Mikey & Momo, Inc.
Volume 166 · 166 F.T.C. 51
deceptive advertisinghealth claimsendorsements
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Mikey & Momo, Inc., 166 F.T.C. 51 (2018). Consumer Law Library, https://consumerlawlibrary.org/decisions/v166-0003
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IN THE MATTER OF MIKEY & MOMO, INC., FORMERLY D/B/A MIKEY & MOMO LLC, ALSO D/B/A AROMAFLAGE, MICHAEL FENSTERSTOCK, AND MELISSA MATARESE FENSTERSTOCK CONSENT ORDER, ETC. IN REGARD TO ALLEGED VIOLATIONS OF SECTION 5 OF THE FEDERAL TRADE COMMISSION ACT Docket No. C-4655; File No. 162 3234 Complaint, August 7, 2018 – Decision, August 7, 2018 This consent order addresses Mikey & Momo, Inc.’s advertising for Aromaflage and Aromaflage Wild sprays and candles. The complaint alleges that the respondents violated Section 5(a) of the FTC Act by representing that their sprays and candles effectively repelled mosquitoes, including mosquitoes that carry Zika virus and other diseases, worked as well as products containing 25% DEET, were effective for 2.5 hours, and that their efficacy was scientifically proven. The complaint also alleges that the respondents violated Section 5(a) by disseminating 5-star reviews by purported ordinary consumers and failing to disclose that certain endorsers had material connections with the respondents and their products, namely that several were close relatives and, in one instance, one of the respondents herself. The consent order prohibits any representation that a covered product repels insects, or about its health benefits, performance, efficacy, safety, or side effects, unless it is non-misleading and supported by competent and reliable scientific evidence.
Participants For the Commission: Mary Johnson, Karen Mandel and Shira Modell. For the Respondents: Spencer Elg, Dana Rosenfeld and Kristi Wolfe, Kelley Drye & Warren.
COMPLAINT The Federal Trade Commission, having reason to believe that Mikey & Momo, Inc. and Michael Fensterstock and Melissa Matarese Fensterstock, individually and as officers of Mikey & Momo, Inc., (collectively, “Respondents”) have violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges:
1. Respondent Mikey & Momo, Inc., formerly doing business as Mikey & Momo LLC, also doing business as Aromaflage, is a Delaware corporation with its principal office or place of business in Englewood, New Jersey.
VOLUME 166 Complaint 2. Respondent Michael Fensterstock is an officer of the Corporate Respondent, Mikey & Momo, Inc. Individually or in concert with others, he formulates, directs, or controls the policies, acts, or practices of the Corporate Respondent. His principal office or place of business is the same as that of the Corporate Respondent. 3. Respondent Melissa Matarese Fensterstock is an officer of the Corporate Respondent, Mikey & Momo, Inc. Individually or in concert with others, she formulates, directs, or controls the policies, acts, or practices of the Corporate Respondent. Her principal office or place of business is the same as that of the Corporate Respondent. 4. Respondents have manufactured, advertised, labeled, offered for sale, sold, and distributed products to consumers, including: Aromaflage and Aromaflage Wild “botanical fragrance & insect repellent” sprays; and Aromaflage and Aromaflage Wild “botanical insect repelling” candles (collectively, “Aromaflage sprays and candles”). 5. The acts and practices of Respondents alleged in this complaint have been in or affecting commerce, as “commerce” is defined in Section 4 of the Federal Trade Commission Act.
6. Respondents advertise their Aromaflage sprays and candles as effective mosquito repellents.
7. Aromaflage sprays and candles are advertised as DEET-free and containing the following:
A. Aromaflage spray contains alcohol, water, and essential oils of vanilla, cedarwood, orange, patchouli, and vanillin (Ex. A at 3); B. Aromaflage Wild spray contains alcohol, water, and essential oils of geranium, lemon grass, cedar leaf, cedarwood, thyme, rosewood, balsam, lavandin, spruce, patchouli, and cardamom (Ex. A at 5); C. Aromaflage candles contain “100% vegan soy wax” with “the same essential oil blend as Aromaflage®” plus “nourishing Vitamin E” (Ex. B at 2); and D. Aromaflage Wild candles contain “all natural soy wax” with “Spicy cardamom, warm cedarwood, & snappy spruce - a spa like scent” (Ex. B at 4).
8. Since at least 2013, Respondents have sold Aromaflage sprays and candles on their website, Aromaflage.com. Respondents also have sold the products in certain retail stores and on Amazon.com. Respondents have charged $30 for an 8 milliliter bottle of spray, $65 for a 50-milliliter bottle of spray, and $40 for a 7.5-ounce candle. 53 MIKEY & MOMO, INC.
Complaint 9. To induce consumers to purchase Aromaflage sprays and candles, Respondents have disseminated or caused to be disseminated advertisements, packaging, and promotional materials, including, but not necessarily limited to, the attached Exhibits A through H. These materials contain the following statements, among others: A. Exhibit A, Selected pages from Aromaflage.com website (captured 9/7/2016, bracketed text supplied) YOU’RE A MOSQUITO MAGNET? enjoy the outdoors with our bug repelling fragrances
THE FRAGRANCE THAT DOES BOTH 2-in-1 fragrance + bug repeller The Bug Spray That Smells Nice
Aromaflage is a 2-in-1 fine fragrance with function. Scientifically tested, effective, and beautiful, Aromaflage® is a new category in beauty and wellness: fragrance with function. Our first line of fine fragrances & candles naturally repels mosquitoes as well as the leading brand.
AROMAFLAGE® 50ML [Tab labeled “Tested and Effective”] THE INTEGRITY OF OUR PRODUCTS Aromaflage has been rigorously tested at one of the world’s leading Universities and found to be as effective at repelling mosquitoes as the leading brand.
Aromaflage repels mosquitoes that may carry Zika, Dengue, Chikungunya, and Yellow Fever.
As effective as 25% Deet over 2.5 hours[.]
AROMAFLAGE® WILD 50ML VOLUME 166 Complaint [Tab labeled “Tested and Effective”] THE INTEGRITY OF OUR PRODUCTS Aromaflage Wild has been rigorously tested at one of the world’s leading Universities and found to be as effective at repelling mosquitoes as the leading brand.
Aromaflage Wild repels mosquitoes that may carry Zika, Dengue, Chikungunya, and Yellow Fever.
As effective as 25% Deet over 2.5 hours[.]
HOW DOES AROMAFLAGE® BOTANICAL FRAGRANCE & INSECT REPELLENT WORK? AROMAFLAGE SCIENTIFIC STUDIES One of our core principles is efficacy. We develop products that work. We’ve tested Aromaflage in a world renowned mosquito University laboratory and demonstrated that Aromaflage outperforms DEET at 7% as well as Citronella. Aromaflage works as well as 25% DEET over 2.5 hours.
Testing also showed that Aromaflage repels mosquitoes that may carry Zika, Dengue, Chikungunya, and Yellow Fever[.] B. Exhibit B, Selected pages from Aromaflage.com website (captured by Internet Archive 9/26/2016, downloaded 8/22/2017, bracketed text supplied) AROMAFLAGE® 7.5OZ CANDLE [Tab labeled “Description”] Aromaflage™ is a fine fragrance that also repels insects Free of DEET, chemicals, and parabens Repels mosquitoes that may carry Zika, Dengue, Chikungunya, and Yellow Fever ABOUT US 55 MIKEY & MOMO, INC.
Complaint Scientifically tested, efficacious, and beautiful, Aromaflage is a new category.
AROMAFLAGE® WILD 7.5OZ CANDLE [Tab labeled “Tested and Effective”] THE INTEGRITY OF OUR PRODUCTS Aromaflage Wild has been rigorously tested at one of the world’s leading Universities and found to be as effective at repelling mosquitoes as the leading brand.
Aromaflage Wild repels mosquitoes that may carry Zika, Dengue, Chikungunya, and Yellow Fever.
Category: best outdoor candle, bug repellent, insect repellent, mosquitoes, natural, natural bug repellent, natural bug spray, travel bug spray Type: Candle C. Exhibit C, Package labeling for Aromaflage spray Aromaflage® botanical fragrance & insect repellent
TESTED & EFFECTIVE NO DEET, NO HARSH CHEMICALS Aromaflage® fragrance with function AROMAFLAGE® IS A FINE FRAGRANCE THAT NATURALLY REPELS MOSQUITOES. SCIENTIFICALLY TESTED, AROMAFLAGE® IS AS EFFECTIVE AS DEET BASED PRODUCTS & WITHOUT ANY HARSH CHEMICALS.
VOLUME 166 Complaint SPRAY LIBERALLY ON EXPOSED SKIN. BEST IF RUBBED INTO SKIN. REAPPLY EVERY 2.5 HOURS TO OPTIMIZE PROTECTION & TO MAINTAIN FRESH SCENT.
D. Exhibit D, Package labeling for Aromaflage candle Aromaflage™ botanical insect repelling candle Repels mosquitoes that may carry Dengue, Chikungunya, & Yellow Fever E. Exhibit E, Amazon.com storefront for Aromaflage Wild spray (captured 2/22/2017, bracketed text supplied) (See Ex. F for similar endorsements) Aromaflage wild-fragrance with function. Aromaflage is a fine fragrance that also repels insects. Scientifically tested and effective. In efficacy studies, aromaflage wild was as effective as 25 percent deet over 2.5 hours. Aromaflage repels mosquitoes that may carry zika, dengue, chikungunya and yellow fever. Free of deet, chemicals, and parabens and other harsh chemicals. . . .
I love Wild. I wear it every day as a ...
By Sheri Matarese on July 26, 2016 Scent Name: Aromaflage Wild Size: 4 Fluid Ounce I love Wild. I wear it every day as a perfume. It also really works to keep the bugs away. It smells very musky and woodsy. Its [sic] an amazing product.
Both men and women love it.
By Stacey Tompkins on July 26, 2016 Scent Name: Aromaflage Wild Size: 4 Fluid Ounce We use this at our lakehouse all summer. Both men and women love it….Our guests are happy and with no bug bites[.]
57 MIKEY & MOMO, INC.
Complaint Finally felt like a lady outdoors By Melissa Matarese on July 26, 2016 Scent Name: Aromaflage Wild Size: 4 Fluid Ounce I wouldn’t have survived my last trip to Nevis without this. Finally felt like a lady outdoors. It works too. no [sic] bites!
Five Stars By Mary Denker on July 28, 2016 Scent Name: Aromaflage Wild Size: 4 Fluid Ounce Was the must have item on my trip to the Costa Rican jungle. F. Exhibit F, Amazon.com storefront for Aromaflage Wild candle (captured 2/22/2017) Aromaflage wild-fragrance with function. A fine candle that also repels insects. Scientifically tested and effective. In efficacy studies, aromaflage wild was as effective as 25 percent deet. Free of deet, chemicals, and parabens and other harsh chemicals. . . .
10. Respondents Michael Fensterstock and Melissa Matarese Fensterstock also personally promoted the efficacy of their Aromaflage sprays and candles. For example, they published a series of YouTube videos in which they promote the products, including one in which they both appear and Melissa Matarese Fensterstock made the following statements: Exhibit G, Transcript of You Tube Video “How to Use Aromaflage Botanical Fragrance and Insect Repellent”
MELISSA FENSTERSTOCK: Unlike other fragrances, Aromaflage needs to be rubbed in. So make sure you do that. It will be effective for about two and a half hours, and then it needs to be reapplied.
So remember to reapply every two and a half hours and to rub it in. 11. Respondent Melissa Matarese Fensterstock also appeared on QVC to promote the Aromaflage candle in a video the Respondents later disseminated on the Aromaflage website and YouTube, in which she stated, among other things, “We’ve done university testing and the VOLUME 166 Complaint product works as well as a number of the leading brands out there.” (Ex. H, Transcript of QVC Video, at 5.) 12. The Respondents commissioned testing of several formulations of the Aromaflage and Aromaflage Wild sprays, including the two marketed versions. The testing also included four commercially-available insect repellents, including an EPA-registered product containing 25% DEET, and water.
A. The test methodology consisted of placing twenty Aedes Aegypti mosquitoes in a static air chamber that contained untreated paper at one end and paper treated with one of the substances listed above at the other end, then comparing how many mosquitoes were in each half of the chamber at timed intervals for 150 minutes.
B. The testing did not: (1) include Aromaflage or Aromaflage Wild candles; (2) use human subjects, even though the Aromaflage products are intended to overcome mosquitoes’ attraction to human odors; or (3) use more than one species of mosquito, even though other species can carry many of the diseases cited in Respondents’ advertising and can react differently to the same repellent.
C. The testing results show (1) at the 30-minute mark, more mosquitoes were in the Aromaflage spray-treated half of the chamber than in the untreated half, and at the 60-minute mark, nearly one-third of the mosquitoes were still in the treated half; (2) the Aromaflage spray performed worse than water for the first thirty minutes; and (3) the 25%-DEET product performed better than the Aromaflage and Aromaflage Wild sprays for at least the first ninety minutes.
13. According to the Environmental Protection Agency, DEET [N,N-diethyl-metatoluamide] is the active ingredient in many insect repellent products and “DEET repels . . . mosquitoes from two to twelve hours depending on the percentage of DEET in the product.” (See https://www.epa.gov/insect-repellents/deet, last accessed Oct. 17, 2017.) Count I False or Unsubstantiated Insect Repellency Claims 14. In connection with the manufacturing, advertising, labeling, offering for sale, sale, or distribution of Aromaflage sprays and candles, Respondents have represented, directly or indirectly, expressly or by implication, that:
A. Aromaflage sprays and candles effectively repel mosquitoes, including mosquitoes that may be carrying Zika virus, dengue, chikungunya, and yellow fever;
59 MIKEY & MOMO, INC.
Complaint B. Aromaflage sprays and candles repel mosquitoes as effectively as 25% DEET;
C. Aromaflage sprays effectively repel mosquitoes for 2.5 hours; and D. Aromaflage sprays repel mosquitoes as effectively as 25% DEET for 2.5 hours.
15. The representations set forth in Paragraph 14 are false or misleading, or were not substantiated at the time the representations were made. Count II False Establishment Claims 16. In connection with the manufacturing, advertising, labeling, offering for sale, sale, or distribution of Aromaflage sprays and candles, Respondents have represented, directly or indirectly, expressly or by implication, that:
A. Aromaflage sprays and candles are scientifically proven to effectively repel mosquitoes;
B. Aromaflage sprays and candles are scientifically proven to repel mosquitoes as effectively as 25% DEET;
C. Aromaflage sprays are scientifically proven to repel mosquitoes as effectively as 25% DEET for 2.5 hours.
17. In fact, including for the reasons set forth in Paragraph 12, A. Aromaflage sprays and candles are not scientifically proven to effectively repel mosquitoes;
B. Aromaflage sprays and candles are not scientifically proven to repel mosquitoes as effectively as 25% DEET; and C. Aromaflage sprays are not scientifically proven to repel mosquitoes as effectively as 25% DEET for 2.5 hours.
Therefore, the representations set forth in Paragraph 16 are false or misleading. Count III Deceptive Endorsement Claim 18. Through the means described in Paragraph 9, including but not necessarily limited to Exhibits E and F, Respondents have represented, directly or indirectly, expressly or by VOLUME 166 Complaint implication, that the product reviews posted online by Melissa Matarese, Sherri Matarese, Mary Denker, and Stacey Tompkins reflect the experiences and opinions of ordinary impartial users of Aromaflage sprays and candles.
19. In fact, the product reviews posted online by Melissa Matarese, Sheri Matarese, Mary Denker, and Stacey Tompkins do not reflect the experiences and opinions of ordinary impartial users of Aromaflage sprays and candles because Melissa Matarese is Respondent Melissa Matarese Fensterstock, who has a financial interest in the sale of the product, and Sheri Matarese, Mary Denker, and Stacey Tomkins are her mother and aunts. Therefore, the representation set forth in Paragraph 18 is false or misleading. Count IV Deceptive Failure to Disclose – Material Connections with Consumer Endorsers 20. In connection with the manufacturing, advertising, labeling, offering for sale, sale, or distribution of Aromaflage sprays and candles, Respondents have represented, directly or indirectly, expressly or by implication, that the reviews of Aromaflage sprays and candles posted by Melissa Matarese, Sheri Matarese, Mary Denker, and Stacey Tompkins on Amazon.com, as set forth in Paragraph 9, reflect the experiences and opinions of users of Aromaflage sprays and candles.
21. In instances in which Respondents have made the representation set forth in Paragraph 20, Respondents have failed to disclose that those individuals had material connections with Respondents. Specifically, Melissa Matarese is Respondent Melissa Matarese Fensterstock, who has a financial interest in the sale of the product, and Sheri Matarese, Mary Denker, and Stacey Tompkins are her mother and aunts. These facts would be material to consumers in evaluating the reviews for Aromaflage sprays and candles in connection with a purchase or use decision.
22. Respondents’ failure to disclose the material information described in Paragraph 21, in light of the representation set forth in Paragraph 20, is a deceptive act or practice. Violations of Section 5 23. The acts and practices of Respondents as alleged in this complaint constitute unfair or deceptive acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act.
THEREFORE, the Federal Trade Commission, this seventh day of August 2018, has issued this Complaint against Respondents.
By the Commission, with Commissioner Chopra voting “abstain.” 61 MIKEY & MOMO, INC.
Complaint Exhibit A www.aromaflage.com VOLUME 166 Complaint ood a ker’ IN THE PRESS 0/095 Forbes VOGUE TODAY Town&Country .\éw.Vorx, Marieclaire EheNew York Times |! |, | | COMPANY INFO.
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VOLUME 166 Complaint Exhibit B
MIKEY & MOMO, INC.
Complaint Aromaflage® Wild 7.Soz Candle hitps://web archive org web/'20160926212030/hips://www.aromaflage.c AROMAFLAGE® WILD 7.50Z CANDLE Quantity 40.00 Desception Testad ans Efectve Video BASED ON BEAUTY, FUNCTION, AND EFFICACY @ Aromatiage Wiki fs a fine candle that alsa repets insects “ All hour bum ta Fd ¢ Spicy cantamom, warm cedanemod, & snappy spruce ~ a spa lke scent 4 Al natural sey ware well Weed Mee colon wick 2 GSS 9 4 /OUSALNE Ine Fem ln » Makes & grast git © eee of DEET, parabens, ad offer harsh chereais 2 Complimentary snipping for oxsers over $150 mn Ine USA » States other than NJ Tax few best outdoor candice, bug mpellert, insect repellent, monpatoes, Natural, natural bug repellent, natural bug spray, faved bug spray Candie ¥vrisae Giwnire AREVIEW eenanee SOP A ners es RITE TERY COMPANY INFO MAIN MENU ABOUTUS NEWS & UPDATES Gontact Us ‘Shap Aromadiage & o 24-5 fine fragrance wih) Shan up fo gel the latest maw products and How Aramaflaga Weeks About function Sceewitically tested, eTective, and Promotions and receive 10% off your frst beauttul Asomjafiage® it. 3 mew cap Teatirnarnals Ratailaes aR? Sec beauty and welinsss: fragrance veh func ion Want at Seriee Buzz Cur first kine of fine fragrances & Dtselaamer candies naturally repels moaquitoes as wall Ex. B, Page 4 of 5 lof2 8/22/2017 3:11 PM Aromaflage® Wild 7.502 Candle lot2 COMPANY INFO Contact Us How Aramaflaga Weeks Tecatirrrornals Terms of Serves Disclamer VOLUME 166 MAIN MENU ‘Shap About Retaioes Bure Complaint hitps:/web archive.org web/'20160926212030/hnps://www.aromaflage.c AROMAFLAGE® WILD 7.50Z CANDLE Quantity 340.00 Descrgnon Tasted and Efiectve Video THE INTEGRITY OF OUR PRODUCTS # Avomafiage Yili nas been ngoroushy tested at one of the worlds Jeading Universties aed fovnd 10 be 23 eTecive of repeating Mosw Aes as Ine adeg beard.
«Cur products are camtaly formutaied by the finest tragrance housac wih the tnghes! Quatly injreuients + Avonafiage Wid repels mosquitoes that may carry Dba, Dengue, Chinengunye, and Yellow Fewer best cufdoor candle bug ropeliont, imsact rapaliant, mosquitces, natura’, natural Gag fapellent, natura Gug spray. tavet bug spray Canale ¥ eos een ABOUTUS NEWS & UPDATES Aromadlage 1s a 2.3 fine fragrance wey Sean up fo gel the latest paw products and function Sceewitically tested, eTective, and Promotions and receive 10% off your ist beauttul Asorattiage® ito mew caheQory in purchase brauty and wellness: fragrance vet func ion Cen first ine of fine fragrances & candies naturally repels mosquitoes as well Ex. B, Page Sof 5 8/22/2017 3:11 PM 73 MIKEY & MOMO, INC.
Complaint Exhibit C VOLUME 166 Complaint Exhibit D 75 MIKEY & MOMO, INC.
Complaint Exhibit E
719 MIKEY & MOMO, INC.
Complaint Amazon.com: Aromaflage botanical fragrance and insect repellent 0.250z: Luxury Beauty | | 3 i 9 https://www.amazon.com/Aromatlage-botanical-tragrance-insect-repellent/dp/B01AH4SUEQ'r... = me ee be i) eo Aromraftage Eau de Toteite = vornafiaga Sloap Eau de ‘All Natural Masquer Mesquitavort Al Natural EO Producis Broath Soray, -Arorrmifiage Wild Candie, Nator! Women's Kiddan Spray Toilette Spray, 03 A. oz. Ropollert Bracalets Value Mosquito Repellent Organic Refrash, 0.33 TBoz. Glamour Full Contour reais wows Pack Twetve (12) Pack (2 ‘Bracelets - Five (5) Pack - Ounce wiirirws Underwire Bra. $3000 Prime $30 00 Prime Packs of 6) - Deet Free Deet Free - Deters Bugs rears $40.00 Prime wwiewt 16s RRRET 16 geese Ma $24.38 - $133 22 315.90 Prime 99.90 “Prime Set up an Amazon Giveaway Amazon Giveaway allows you to run promotional @veaways in order lo Geate buzz, reward your audience, ard attract new followers and customers. | 2am more about Amazon Giveaway This em Aromanage botanical Fragrance and insect repellent 0 2502 ‘Setup agiveaway Diecaimar: Whi we work co encura that product information i correct, on occasion mamfacturars may aker thek grader lees. Actual product packaging and matarisk may contain more andlor dffarum information thse that shown on ou Web ste. We recommend thac you do not solely rely on the nformetion presented and that you always read Bbet, wamings, and rectors before wing or comzumme 3 product, For addtoral efermaton sbout 3 product, sleaze cortact the manfactwrer. Comment on the ste for reference purposes and © mot imtended to substtute for advica givan by a phiysidin, pharmack, er othur kensed hashh-care professional. You chowd cet usu thé: ifermiztion as aulf-dagnosis or for weating a heath problem or dence. Contact your haakh-care provider immadately f you suspect that yau have 2 medical problem. Information and statements regarding demsry tunpiements have not been evaluated by the Food and Drug Admnetrstin and are not intended to dgnose, treat, cure, or prevent any disease or heath condten, Amazon.com assames no shity for Raccumces or mestatements about products. Ex_E, Page 5 of 5 Sof7 2/22/2017 2:05 PM VOLUME 166 Complaint Exhibit F
Amazon.com: Aromaflage Wild Candle, 7.5 oz.: Luxury Beauty 30f 6 Customer Reviews wii s 5.0 out of 5 stars + 5 star WY 100% 4star o% 3star O% 2 star 0% 1 star 0% See all verified purchase reviews + Top Customer Reviews ‘Share your thoughts with other customers Write a customer reviery Op its also great that you can use as a wine glass when... By Mary Denker on July 28, 2016 VOLUME 166 Complaint https://www.amazon.com/Aromaflage-Wild-Candle-7-5-0z/dp/BO1COOTI7E/ref=pd_sim_510... ae Eucalyptus Essential Oil - An All Season Favorite £ Creation Pharm Eucalyptus Oil, 30 mb wkedd v2 $A $8.97 Prine Add to Cart Search Customer Reviews:
Luxurious and effective as far as keeping the bugs away! The scent is really refreshing. its also great that you can use as a wine glass when finished. Although a it took awhile to bum he en ire candle which is great _) Comment Wasthis reviewhelptul to you? Yes | No Report abuse Torr’ We burn these all summer long on our patio. ._ By She Matarese on july 26, 2016 Customer Questions & Answers ‘We bum these all summer long on our patio. The scent does not interfere with dinner at all and it really works. | also burn il in the kitchen near our fruit basket where here are often fruit ies Comment (One: person found this hejpmul. Was this review etptulto you? | Yes re ww we Five Stars By Retly Weaver on August 1, 2015 Vented Purchase great fragrancell! does a good job keeping bugs away Comenent One person found this helpful. Was this rewiew helpful to you? | Yes | hh Five stars By Stacey Tompkins on May 16, 2015, Awesome product! Lave it and works great.
Comment | One person found this heiptul. Was this review neipful to you? | Yes _| veer Five stars By Amazon Customer on July 29, 2016 This is a must have for surnmer bbqs! Comment Was this revewhelpfultoyou? Yes | No Report abuse Wee ww Nice candle! By Elizabeth on May 16, 20° Verified Purchase I like this Candie. | con't know if It repels mosquito’s, but it Is nice. No - Report abuse No Report abuse No Report abuse Ex. F, Page 3 of 3 2/22/2017 2:13 PM 83 MIKEY & MOMO, INC.
Complaint Exhibit G
VOLUME 166 Complaint Exhibit H
101 MIKEY & MOMO, INC.
Decision and Order DECISION AND ORDER The Federal Trade Commission (“Commission”) initiated an investigation of certain acts and practices of the Respondents named in the caption. The Commission’s Bureau of Consumer Protection (“BCP”) prepared and furnished to Respondents a draft Complaint. BCP proposed to present the draft Complaint to the Commission for its consideration. If issued by the Commission, the draft Complaint would charge the Respondents with violation of the Federal Trade Commission Act.
Respondents and BCP thereafter executed an Agreement Containing Consent Order (“Consent Agreement”). The Consent Agreement includes: 1) statements by Respondents that they neither admit nor deny any of the allegations in the Complaint, except as specifically stated in this Decision and Order, and that only for purposes of this action, they admit the facts necessary to establish jurisdiction; and 2) waivers and other provisions as required by the Commission’s Rules.
The Commission considered the matter and determined that it had reason to believe that Respondents have violated the Federal Trade Commission Act, and that a Complaint should issue stating its charges in that respect. The Commission accepted the executed Consent Agreement and placed it on the public record for a period of 30 days for the receipt and consideration of public comments. The Commission duly considered any comments received from interested persons pursuant to Commission Rule 2.34, 16 C.F.R. § 2.34. Now, in further conformity with the procedure prescribed in Commission Rule 2.34, the Commission issues its Complaint, makes the following Findings, and issues the following Order: Findings 1. The Respondents are:
a. Respondent Mikey & Momo, Inc., formerly doing business as Mikey & Momo LLC, also doing business as Aromaflage, is a Delaware corporation with its principal office or place of business in Englewood, New Jersey. b. Respondent Michael Fensterstock is an officer of the Corporate Respondent, Mikey & Momo, Inc. Individually or in concert with others, he formulates, directs, or controls the policies, acts, or practices of the Corporate Respondent. His principal office or place of business is the same as that of the Corporate Respondent.
c. Respondent Melissa Matarese Fensterstock is an officer or member of the Corporate Respondent, Mikey & Momo, Inc. Individually or in concert with others, she formulates, directs, or controls the policies, acts, or practices of the Corporate Respondent. Her principal office or place of business is the same as that of the Corporate Respondent. VOLUME 166 Decision and Order 2. The Commission has jurisdiction over the subject matter of this proceeding and over the Respondents, and the proceeding is in the public interest. ORDER Definitions For purposes of this Order, the following definitions apply: A. “Clearly and conspicuously” means that a required disclosure is difficult to miss (i.e., easily noticeable) and easily understandable by ordinary consumers, including in all of the following ways:
1. In any communication that is solely visual or solely audible, the disclosure must be made through the same means through which the communication is presented. In any communication made through both visual and audible means, such as a television advertisement, the disclosure must be presented simultaneously in both the visual and audible portions of the communication even if the representation requiring the disclosure (“triggering representation”) is made through only one means. 2. A visual disclosure, by its size, contrast, location, the length of time it appears, and other characteristics, must stand out from any accompanying text or other visual elements so that it is easily noticed, read, and understood.
3. An audible disclosure, including by telephone or streaming video, must be delivered in a volume, speed, and cadence sufficient for ordinary consumers to easily hear and understand it.
4. In any communication using an interactive electronic medium, such as the Internet or software, the disclosure must be unavoidable. 5. On a product label, the disclosure must be presented on the principal display panel.
6. The disclosure must use diction and syntax understandable to ordinary consumers and must appear in each language in which the triggering representation appears.
7. The disclosure must comply with these requirements in each medium through which it is received, including all electronic devices and face-toface communications.
8. The disclosure must not be contradicted or mitigated by, or inconsistent with, anything else in the communication.
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Decision and Order 9. When the representation or sales practice targets a specific audience, such as children, the elderly, or the terminally ill, “ordinary consumers” includes reasonable members of that group.
B. “Close proximity” means that the disclosure is very near the triggering representation. For example, a disclosure made through a hyperlink, pop-up, interstitial, or other similar technique is not in close proximity to the triggering representation.
C. “Cosmetic” means (1) articles to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof intended for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such article; except that such term shall not include soap.
D. “Covered product” means any product purported, designed, or intended to repel insects, including Aromaflage botanical fragrance & insect repellent spray, Aromaflage botanical insect repelling candle, Aromaflage Wild botanical fragrance & insect repellent spray, and Aromaflage Wild botanical insect repelling candle.
E. “Device” means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:
1. recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, 2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals, or 3. intended to affect the structure or any function of the body of humans or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
F. “Drug” means: (a) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; (b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; (c) articles (other than food) intended to affect the structure or any function of the body of humans or other animals; and VOLUME 166 Decision and Order (d) articles intended for use as a component of any article specified in (a), (b), or (c); but does not include devices or their components, parts, or accessories. G. “Food” means: (a) any article used for food or drink for humans or other animals; (b) chewing gum; and (c) any article used for components of any such article. H. “Including” means including but not limited to. I. “Respondents” means the Corporate Respondent and the Individual Respondents, individually, collectively, or in any combination.
1. “Corporate Respondent” means Mikey & Momo, Inc., formerly doing business as Mikey & Momo LLC, also doing business as Aromaflage, a corporation, and its successors and assigns.
2. “Individual Respondents” means Michael Fensterstock and Melissa Matarese Fensterstock.
I.
Prohibited Misleading and Unsubstantiated Representations About Insect Repellency IT IS ORDERED that Respondents, and Respondents’ officers, agents, employees, and attorneys, and all other persons in active concert or participation with any of them, who receive actual notice of this Order, whether acting directly or indirectly, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any covered product must not make any representation, expressly or by implication, including through the use of a product name, endorsement, depiction, or illustration: A. That such product is an effective mosquito or insect repellent; B. That such product repels mosquitoes or other insects that may be carrying Zika virus, dengue, chikungunya, yellow fever, or any other disease; C. That such product repels mosquitoes or other insects for a specified period of time;
D. That such product repels mosquitoes or other insects better than or as well as DEET or any other product or ingredient; or E. About the health benefits, performance, efficacy, safety, or side effects of such product;
unless the representation is non-misleading, including that, at the time such representation is made, Respondents possess and rely upon competent and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted by experts in the field of 105 MIKEY & MOMO, INC.
Decision and Order insect repellency, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. For purposes of this Provision, “competent and reliable scientific evidence” means tests, analyses, research, or studies that (1) have been conducted and evaluated in an objective manner by experts in the field of insect repellency; (2) are generally accepted by such experts to yield accurate and reliable results; and (3) are human clinical testing of the covered product, when such experts would generally require such human clinical testing to substantiate that the representation is true.
In addition, when such tests or studies are human clinical testing, all underlying or supporting data and documents generally accepted by such experts as relevant to an assessment of such testing as set forth in the Provision entitled Preservation of Records Relating to Competent and Reliable Human Clinical Tests or Studies must be available for inspection and production to the Commission.
II.
Prohibited Misrepresentations Regarding Tests, Studies, or Other Research IT IS FURTHER ORDERED that Respondents, and Respondents’ officers, agents, employees, and attorneys, and all other persons in active concert or participation with any of them, who receive actual notice of this Order, whether acting directly or indirectly, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any covered product must not make any misrepresentation, expressly or by implication, including through the use of a product name, endorsement, depiction, or illustration: A. About the existence, contents, validity, results, conclusions, or interpretations of any test, study, or other research, including that the product is proven to effectively repel mosquitoes or other insects, to effectively repel mosquitoes or other insects that carry disease or a specified disease, to effectively repel mosquitoes or other insects for a specified period of time, or to repel mosquitoes or insects as well as or better than DEET or any other product or ingredient; or B. That the performance or benefits of the product are scientifically or clinically proven or otherwise established.
VOLUME 166 Decision and Order III.
Preservation of Records Relating to Competent and Reliable Human Clinical Tests or Studies IT IS FURTHER ORDERED that, with regard to any human clinical test or study (“test”) upon which Respondents rely to substantiate any claim covered by this Order, Respondents must secure and preserve all underlying or supporting data and documents generally accepted by experts in the field as relevant to an assessment of the test, including: A. All protocols and protocol amendments, reports, articles, write-ups, or other accounts of the results of the test, and drafts of such documents reviewed by the test sponsor or any other person not employed by the research entity; B. All documents referring or relating to recruitment; randomization; instructions, including oral instructions, to participants; and participant compliance; C. Documents sufficient to identify all test participants, including any participants who did not complete the test, and all communications with any participants relating to the test; all raw data collected from participants enrolled in the test, including any participants who did not complete the test; source documents for such data; any data dictionaries; and any case report forms; D. All documents referring or relating to any statistical analysis of any test data, including any pretest analysis, intent-to-treat analysis, or between-group analysis performed on any test data; and E. All documents referring or relating to the sponsorship of the test, including all communications and contracts between any sponsor and the test’s researchers. Provided, however, the preceding preservation requirement does not apply to a reliably reported test, unless the test was conducted, controlled, or sponsored, in whole or in part by (1) any Respondent; (2) any Respondent’s officers, agents, representatives, or employees; (3) any other person or entity in active concert or participation with any Respondent; (4) any person or entity affiliated with or acting on behalf of any Respondent; (5) any supplier of any ingredient contained in the product at issue to any of the foregoing or to the product’s manufacturer; or (6) the supplier or manufacturer of such product.
For purposes of this Provision, “reliably reported test” means a report of the test has been published in a peer-reviewed journal, and such published report provides sufficient information about the test for experts in the relevant field to assess the reliability of the results. For any test conducted, controlled, or sponsored, in whole or in part, by Respondents, Respondents must establish and maintain reasonable procedures to protect the confidentiality, security, and integrity of any personal information collected from or about participants. These procedures must be documented in writing and must contain administrative, technical, and 107 MIKEY & MOMO, INC.
Decision and Order physical safeguards appropriate to Respondents’ size and complexity, the nature and scope of Respondents’ activities, and the sensitivity of the personal information collected from or about the participants.
IV.
Prohibited Representations Regarding Endorsements IT IS FURTHER ORDERED that Respondents, and Respondents’ officers, agents, employees, and attorneys, and all other persons in active concert or participation with any of them, who receive actual notice of this Order, whether acting directly or indirectly, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any covered product, or any food, drug, device, or cosmetic for which health-related benefit, efficacy, performance, or safety claims are made, must not make any misrepresentation, expressly or by implication, about the status of any endorser or person providing a review of the product, including a misrepresentation that the endorser or reviewer is an independent or ordinary user of the product.
V.
Required Disclosures of Material Connections IT IS FURTHER ORDERED that Respondents, and Respondents’ officers, agents, employees, and attorneys, and all other persons in active concert or participation with any of them, who receive actual notice of this Order, whether acting directly or indirectly, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any covered product, or any food, drug, device, or cosmetic for which health-related benefit, efficacy, performance, or safety claims are made, must not make any representation, expressly or by implication, including through the use of a product name, endorsement, depiction, or illustration, about any consumer or other endorser of such product without disclosing, clearly and conspicuously, and in close proximity to that representation, any unexpected material connection between such endorser and (1) any Respondent; or (2) any other individual or entity affiliated with the product.
For purposes of this Provision, “unexpected material connection” means any relationship that might materially affect the weight or credibility of the testimonial or endorsement and that would not reasonably be expected by consumers.
VI.
Acknowledgments of the Order IT IS FURTHER ORDERED that each Respondent, within 10 days after the effective date of this Order, must submit to the Commission an acknowledgment of receipt of this Order sworn under penalty of perjury.
VOLUME 166 Decision and Order VII.
Compliance Reports and Notices IT IS FURTHER ORDERED that Respondents make timely submissions to the Commission:
A. One hundred and eighty days after the issuance date of this Order, each Respondent must submit a compliance report, sworn under penalty of perjury, in which:
1. Each Respondent must: (a) identify the primary physical, postal, and email address and telephone number, as designated points of contact, which representatives of the Commission, may use to communicate with Respondent; (b) identify all of that Respondent’s businesses by all of their names, telephone numbers, and physical, postal, email, and Internet addresses; (c) describe the activities of each business, including the goods and services offered, the means of advertising, marketing, and sales, and the involvement of any other Respondent (which Individual Respondents must describe if they know or should know due to their own involvement); (d) describe in detail whether and how that Respondent is in compliance with each Provision of this Order, including a discussion of all of the changes the Respondent made to comply with the Order; and (e) provide a copy of each Acknowledgment of the Order obtained pursuant to this Order, unless previously submitted to the Commission.
2. Additionally, each Individual Respondent must: (a) identify all his or her telephone numbers and all his or her physical, postal, email and Internet addresses, including all residences; (b) identify all his or her business activities, including any business for which such Respondent performs services whether as an employee or otherwise and any entity in which such Respondent has any ownership interest; and (c) describe in detail such Respondent’s involvement in each such business activity, including title, role, responsibilities, participation, authority, control, and any ownership.
B. For 3 years after the issuance date of this Order, each Respondent must submit a compliance notice, sworn under penalty of perjury, within 14 days of any change in the following:
1. Each Respondent must submit notice of any change in: (a) any designated point of contact; or (b) the structure of Corporate Respondent or any entity that Respondent has any ownership interest in or controls directly or indirectly that may affect compliance obligations arising under this Order, including: creation, merger, sale, or dissolution of the entity or any 109 MIKEY & MOMO, INC.
Decision and Order subsidiary, parent, or affiliate that engages in any acts or practices subject to this Order.
2. Additionally, each Individual Respondent must submit notice of any change in: (a) name, including alias or fictitious name, or residence address; or (b) title or role in any business activity, including (i) any business for which such Respondent performs services whether as an employee or otherwise and (ii) any entity in which such Respondent has any ownership interest and over which such Respondent has direct or indirect control. For each such business activity, also identify its name, physical address, and any Internet address.
C. Each Respondent must submit notice of the filing of any bankruptcy petition, insolvency proceeding, or similar proceeding by or against such Respondent within 14 days of its filing.
D. Any submission to the Commission required by this Order to be sworn under penalty of perjury must be true and accurate and comply with 28 U.S.C. § 1746, such as by concluding: “I declare under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on: _____” and supplying the date, signatory’s full name, title (if applicable), and signature.
E. Unless otherwise directed by a Commission representative in writing, all submissions to the Commission pursuant to this Order must be emailed to [email protected] or sent by overnight courier (not the U.S. Postal Service) to: Associate Director for Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580. The subject line must begin: In re Mikey & Momo, Inc., C-4655. VIII.
Recordkeeping IT IS FURTHER ORDERED that Respondents must create certain records and retain each such record for 5 years. Specifically, Corporate Respondent and each Individual Respondent for any business that such Respondent, individually or collectively with any other Respondents, is a majority owner or controls directly or indirectly, must create and retain the following records:
A. Accounting records showing the revenues from all goods or services sold; B. Personnel records showing, for each person providing services in relation to any aspect of the Order, whether as an employee or otherwise, that person’s: name; addresses; telephone numbers; job title or position; dates of service; and (if applicable) the reason for termination;
VOLUME 166 Decision and Order C. Records of all consumer complaints and refund requests concerning the subject matter of the Order, whether received directly or indirectly, such as through a third party, and any response;
D. A copy of each unique advertisement or other marketing material making a representation subject to this Order;
E. For 5 years from the date of the last dissemination of any representation covered by this Order:
1. All materials that were relied upon in making the representation; and 2. All tests, studies, analysis, demonstrations, other research, or other such evidence in Respondent’s possession, custody, or control that contradicts, qualifies, or otherwise calls into question the representation, or the basis relied upon for the representation, including complaints and other communications with consumers or with governmental or consumer protection organizations; and F. All records necessary to demonstrate full compliance with each Provision of this Order, including all submissions to the Commission.
IX.
Compliance Monitoring IT IS FURTHER ORDERED that, for the purpose of monitoring Respondents’ compliance with this Order:
A. Within 10 days of receipt of a written request from a representative of the Commission, each Respondent must: submit additional compliance reports or other requested information, which must be sworn under penalty of perjury, and produce records for inspection and copying.
B. For matters concerning this Order, representatives of the Commission are authorized to communicate directly with each Respondent. Respondents must permit representatives of the Commission to interview anyone affiliated with any Respondent who has agreed to such an interview. The interviewee may have counsel present.
C. The Commission may use all other lawful means, including posing through its representatives as consumers, suppliers, or other individuals or entities, to Respondents or any individual or entity affiliated with Respondents, without the necessity of identification or prior notice. Nothing in this Order limits the Commission’s lawful use of compulsory process, pursuant to Sections 9 and 20 of the FTC Act, 15 U.S.C. §§ 49, 57b-1.
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Concurring Statement D. Upon written request from a representative of the Commission, any consumer reporting agency must furnish consumer reports concerning Individual Respondents, pursuant to Section 604(2) of the Fair Credit Reporting Act, 15 U.S.C. § 1681b(a)(2).
X.
Order Effective Dates IT IS FURTHER ORDERED that this Order is final and effective upon the date of its publication on the Commission’s website (ftc.gov) as a final order. This Order will terminate on August 7, 2038, or 20 years from the most recent date that the United States or the Commission files a complaint (with or without an accompanying settlement) in federal court alleging any violation of this Order, whichever comes later; provided, however, that the filing of such a complaint will not affect the duration of:
A. Any Provision in this Order that terminates in less than 20 years; B. This Order’s application to any Respondent that is not named as a defendant in such complaint; and C. This Order if such complaint is filed after the Order has terminated pursuant to this Provision.
Provided, further, that if such complaint is dismissed or a federal court rules that the Respondent did not violate any Provision of the Order, and the dismissal or ruling is either not appealed or upheld on appeal, then the Order will terminate according to this Provision as though the complaint had never been filed, except that the Order will not terminate between the date such complaint is filed and the later of the deadline for appealing such dismissal or ruling and the date such dismissal or ruling is upheld on appeal.
By the Commission, with Commissioner Chopra voting “abstain.” STATEMENT OF COMMISSIONER ROHIT CHOPRA In the Matter of Aromaflage Commission File Number 1623234 Today, the Federal Trade Commission is approving a settlement with Melissa and Michael Fensterstock to address their conduct that exploited the recent Zika epidemic. The VOLUME 166 Concurring Statement settlement includes no restitution for consumers, no disgorgement of their ill-gotten gains, and no admission of facts or liability.
The Fensterstocks claimed that their fragrance would protect customers from Zika and other insect- borne diseases as effectively as traditional repellants. Based on facts uncovered in our staff’s thorough investigation, the Fensterstocks had reason to know this claim was not only baseless, but actually contradicted by the research they commissioned. The Fensterstocks grew their business by exposing their customers to health risks related to the Zika virus, including serious birth defects.
The Fensterstocks were extremely successful at promoting this ploy, doubling down on their deception at every turn. In the New York Times, Melissa Fensterstock spoke about how the company fielded daily calls from customers about Zika. In an interview with the Guardian, she noted that Aromaflage was “selling very well, especially given the scare.” In a television interview on Bloomberg, she claimed her “scientific background” helped her “really understand what we can and cannot say about our product . . . .” (She studied neuroscience at Johns Hopkins, bioscience enterprise at the University of Cambridge, and holds an MBA from Harvard Business School.) Aromaflage was featured by the style editor of the Today show, and was even listed as one of Oprah’s Favorite Things.
I don’t believe the Fensterstocks purposely sought to expose their customers to serious health risks. Instead, it seems the thrill and allure of attention and financial success got the best of them. At the same time, their misconduct was extremely serious. Given all these factors, I believe our settlement is too lenient and does not do enough to fence in the Fensterstocks. In other cases involving egregious misconduct,1 the FTC has sought permanent injunctions2 and significant relief for consumers in federal court. While I respect the ongoing concerns within the Commission about our extremely scant resources, I worry that this is not a just outcome. As the Fensterstocks pursue new business ventures, their investors and customers will need to keep a watchful eye over them.
Thousands of entrepreneurs and business owners work hard and play by the rules, including in the health and beauty products sectors. These honest businesses are harmed when they have to compete with companies that cheat their customers. The Federal Trade Commission must protect these honest business owners and operators from unfair business practices by ensuring that those who break the law are fully held to account. 1 The investigation suggests that the Fensterstocks actually misrepresented the results of a study they commissioned, thereby placing the health of their customers at risk. See Compl. ¶ 12. In my view, this makes the Fensterstocks’ conduct more egregious than what is found in typical substantiation cases. 2 The order finalized today is valid only for twenty years. In my view, a court-ordered permanent injunction against false and misleading claims about health and safety would have been more appropriate given the particular facts and circumstances in this matter.
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Analysis to Aid Public Comment ANALYSIS OF CONSENT ORDER TO AID PUBLIC COMMENT The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an agreement containing a consent order as to Mikey & Momo, Inc., Michael Fensterstock, and Melissa Matarese Fensterstock (“respondents”).
The proposed consent order (“order”) has been placed on the public record for 30 days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the order and the comments received, and will decide whether it should withdraw the order or make it final. This matter involves the respondents’ advertising for Aromaflage and Aromaflage Wild sprays and candles. The complaint alleges that the respondents violated Section 5(a) of the FTC Act by deceptively representing that their sprays and candles effectively repelled mosquitoes, including mosquitoes that carry Zika virus and other diseases, worked as well as products containing 25% DEET, were effective for 2.5 hours, and that their efficacy was scientifically proven. The complaint also alleges that the respondents violated Section 5(a) by disseminating 5-star reviews by purported ordinary consumers and by deceptively failing to disclose that certain endorsers had material connections with the respondents and their products, namely that several were close relatives and, in one instance, one of the respondents herself. The order includes injunctive relief that prohibits these alleged violations and fences in similar and related conduct. The provisions related to efficacy claims apply to any “covered product,” which is defined as any product purported, designed, or intended to repel insects. The provisions related to endorsements apply to covered products as well as any food, drug, device, or cosmetic for which health-related benefit, efficacy, performance, or safety claims are made. Part I prohibits any representation that a covered product repels insects, or about its health benefits, performance, efficacy, safety, or side effects, unless it is non-misleading and supported by competent and reliable scientific evidence. Such evidence must consist of tests or studies that (1) have been conducted and evaluated in an objective manner by experts in the field of insect repellency; (2) are generally accepted by such experts to yield accurate and reliable results; and (3) are human clinical testing of the covered product, when such experts would generally require such human clinical testing to substantiate that the representation is true. Part II prohibits, in connection with the sale of a covered product, any misrepresentation about any test or study, or that the performance or benefits of such product are scientifically or clinically proven or otherwise established.
Part III, triggered when the human clinical testing requirement in Part I applies, requires the respondents to secure and preserve all underlying or supporting data and documents generally accepted by experts in the relevant field as relevant to an assessment of the test, such as protocols, instructions, participant-specific data, statistical analyses, and contracts with the test’s researchers. There is an exception for a “Reliably Reported” test, defined as a test that is published in a peer-reviewed journal and that was not conducted, controlled, or sponsored by any respondent or by any supplier of the respondents. Also, the published report must provide VOLUME 166 Analysis to Aid Public Comment sufficient information about the test for experts in the relevant field to assess the reliability of the results.
Part IV prohibits, in connection with the sale of a covered product or any food, drug, device, or cosmetic for which health-related benefit, efficacy, performance, or safety claims are made, any misrepresentation about the status of any endorser or person providing a review of the product, including that he or she is an independent or ordinary user of the product. Part V prohibits, in connection with the sale of a covered product or any food, drug, device, or cosmetic for which health-related benefit, efficacy, performance, or safety claims are made, any representation about any consumer or other endorser of such product without disclosing, clearly and conspicuously, and in close proximity to that representation, any unexpected material connection between such endorser and any respondent, or other individual or entity affiliated with the product. The order defines the terms “clearly and conspicuously” and “unexpected material connection.”
Part VI requires the respondents to submit signed acknowledgments that they received the order.
Part VII requires the respondents to file compliance reports with the Commission; and to notify the Commission of bankruptcy filings or changes in corporate structure that might affect compliance obligations.
Part VIII contains recordkeeping requirements for accounting records, personnel records, consumer correspondence, advertising and marketing materials, and claim substantiation, as well as all records necessary to demonstrate compliance or non-compliance with the order.
Part IX contains other requirements related to the Commission’s monitoring of the respondents’ order compliance.
Part X provides the effective dates of the order, including that, with exceptions, the order will terminate in 20 years.
The purpose of this analysis is to facilitate public comment on the order, and it is not intended to constitute an official interpretation of the complaint or order, or to modify the order’s terms in any way.
115 NECTAR BRANDS LLC Complaint