United States: 2019: The Dietary Supplements And Cosmetics Year In Review – Mondaq News Alerts

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Federal and state legislatures aimed to bring more scrutiny tocosmetics in 2019 by considering measures that would regulateingredients, limit research methods and grant additional authorityto regulatory agencies.

At the federal level, lawmakers have considered the Safe Cosmetics and Personal Care Products Act of2019 and the Cosmetic Safety Enhancement Act of 2019, whichwould give the U.S. Food and Drug Administration (FDA) moreauthority to recall personal care products. The House Subcommitteeon Health, part of the Committee on Energy and Commerce, held a hearing on December 4, 2019, that focused onthe reasoning behind the proposed bills. "The proposedbipartisan bill currently under consideration in Congress wouldreform the U.S. approach to cosmetics regulation, potentially insignificant ways," Shook Partner LaurieHenrytold Corporate Disputes for the magazine's October-December 2019issue.

Other federal efforts included the November introduction of theNatural Cosmetics Act, which aims to definethe term "natural" as applied to cosmetics. Rep. FrankPallone sent a letter in June urging FDA to provide updated information oninspections of imported cosmetics after he learned that the agencyhad not conducted "any foreign cosmetics inspections in FiscalYear (FY) 2019 and does not intend to conduct any inspections in FY2020." The Children's Product Warning Label Act of2019 was introduced in March following headlines about the identification of asbestos in talc-basedchildren's cosmetics, although the bill has not progressedbeyond introduction.

A bipartisan federal bill to ban animal testing for cosmetics,the Humane Cosmetics Act of 2019, was introduced,coinciding with state legislatures banning the sale of cosmeticsproduced with animal testing; Illinois and Nevada joined California in passing such bans,which take effect January 1, 2020.

In addition, California updated its laws to require safety data sheetsfor cosmetic products, while New York banned 1,4-Dioxane, which can be found incosmetics and other personal care products.

The U.S. Food and Drug Administration promised an increasedfocus on dietary supplements in a February 2019 press announcement from then-CommissionerScott Gottlieb. "[T]oday we are announcing a new plan forpolicy advancements with the goal of implementing one of the mostsignificant modernizations of dietary supplement regulation andoversight in more than 25 years," the announcement stated. FDApromised additional efforts in "communicating to the public assoon as possible when there is a concern about a dietary supplementon the market, ensuring that our regulatory framework is flexibleenough to adequately evaluate product safety while also promotinginnovation, continuing to work closely with our industry partners,developing new enforcement strategies and continuing to engage in apublic dialogue to get valuable feedback from dietary supplementstakeholders." The announcement accompanied the posting of 12warning letters and 5 online advisory letters sent to companiesthat the agency asserted were "illegally selling more than 58products, many that are sold as dietary supplements, which areunapproved new drugs and/or misbranded drugs that claim to prevent,treat or cure Alzheimers disease and a number of otherserious diseases and health conditions." In April, FDA unveiled its Dietary Supplement Ingredient Advisory List, atool intended to alert the public when the agency "identifiesingredients that do not appear to be lawfully marketed in dietarysupplements."

As part of Shook's 60 Seconds of Legal Science video series,Houston Managing Partner Jennise Stubbsnoted FDA's role inreviewing dietary supplements. "As dietary supplementpopularity increases and the number of companies manufacturingthese supplements grows, FDA is reviewing the regulatory frameworkfor these products to ensure its processes and procedures ofoversight are flexible enough to evaluate product safety but alsopromote scientific innovation," she explains.

FDA continued issuing warning letters to companies with productionfacilities the agency deemed to be not up to Current GoodManufacturing Practices, including Hi-Tech Pharmaceuticals, SomaLabs Inc., Nutra Solutions USA and Goldstar Distribution, as well as companiesthat allegedly claimed benefits about their products that wouldamount to the products being unapproved new drugs. A large portionof 2019 warning letters in this category were sent to manufacturersof cannabidiol (CBD) products; in addition, FDA sent severalletters to manufacturers of products containing dimethylhexamine(DMHA), including eight manufacturers that appeared in an April posting of warning letters.

The U.S. Federal Trade Commission (FTC) has frequently targeteddietary supplement and cosmetics companies for enforcement actions,arguing that companies engage in marketing tactics the agency foundto be misleading or harmful. These actions continued apace in 2019,with challenges focused on unsubstantiated claims,"risk-free" trial offers and undisclosed marketingpartnerships.

FTC settled a number of cases with supplement producers anddistributors, including the makers of Synovia, which was allegedly marketed as atreatment for arthritis. The marketing included a testimonial inwhich the endorser purportedly "gave away his walker"after using Synovia. An aloe supplement maker was alleged to havemisleadingly marketed its products as "effective treatmentsfor a range of conditions affecting seniors, including chronicpain, ulcerative colitis, diabetes, and acid reflux." Under asettlement agreement, the makers will pay $537,000 of an $18.7million judgment. Unsubstantiated claims about cognitive improvements also drew a complaintfrom FTC; 12 corporate defendants settled with the agency afterthey allegedly claimed the products had been shown in "over2,000 clinical trials" to improve focus by "up to121%."

The agency also filed an action against a company that marketed itsbath and beauty products as organic and vegan despite containingnon-organic ingredients that appear "only in lists that areburied among other text on product labels and websites." Someof the company's products also contained honey and lactose,which are not vegan ingredients. In addition, FTC mailed checks to consumers confused bynegative-option marketing for "risk-free" trials of skincare products and sued a supplement company that allegedly ranan illegal pyramid scheme.

FTC continued to focus on supplement and cosmetics companiespartnering with influencers or other non-traditional brandrepresentatives who fail to disclose their paid relationships. InNovember, FTC released "Disclosures 101 for Social MediaInfluencers," a guide aiming to clarify the measures thatsocial media posters must pursue to ensure their audiencesunderstand that a post is an advertisement. The agency also lookedfor misleading reviews and testimonials shown online by seeminglyimpartial users of personal care products. In February, FTC announced "its first case challenging amarketers use of fake paid reviews on an independent retailwebsite," which it brought against the distributor of aGarcinia cambogia supplement. FTC also settled with skin carecompany Sunday Riley following allegations that thecompany's executives directed employees to leave highlypositive reviews on Sephora's website to ensure thecompany's products retained high star ratings.

The National Advertising Division (NAD), which reviewschallenges to marketing claims brought by competitors or advocacyorganizations, considered several dietary supplement and cosmeticsadvertising complaints in 2019, including a complaint brought bythe Council for Responsible Nutrition. The group challenged themarketing for Plavinol, a dietary supplement purported toaid in treating metabolic syndrome, and NAD found that the researchstudy cited by Nexus Formulas LLC lacked credibility "becauseit was unclear who authored it."

The ad board also faced resistance following some of itsdeterminations, including from Guthy-Renker. NAD told the company thatmarketing for its Crepe Erase "antiaging body caresystem" featured misleading numbers on the percentage of userswho saw improvements after using the product and that thetestimonials from a doctor and Dorothy Hamill were misleading. Thecelebrity endorsement did not reflect the evidence in the recordabout the product's efficacy, NAD found, and the doctor'stestimonial implying the product was better than its competitorswas misleading because the doctor did not review competingproducts' efficacy. Guthy-Renker told NAD it intended to appealon several grounds.

Wink Naturals received multiple complaints about its products,which include sleep supplements, anxiety-relief supplements and cough-syrup supplements. The challengeslargely focused on Wink's marketing towards children, includingsuch statements as, "I get asked A LOT if we make an anxietyproduct for kidsWE DO" and "Helps to improve yourchilds school performance: A good night sleep can lead tomore energy, focus, concentration, information retention, andcreative problem solving. NAD determined the latter phrasingcould be slightly modified into separate sentences to highlight thebenefits of sleep and the relationship between the product andsleep, but the board recommended a number of changes to Wink'smarketing throughout all three products' advertisingcampaigns.

Following the passage of the 2018 Farm Bill, which legalized thecultivation of hemp, cannabidiol (CBD) became the star ingredientof 2019, suspended by itself in oil or featured in supplements,beverages and food. The U.S. Food and Drug Administration (FDA)struggled to keep up with the hype; while CBD stayed in legallimbo, U.S. lawmakers and other public officials urged the agency to take action and create alegal framework for a burgeoning industry capitalizing on thepopularity of CBD and its purported calming and healing effects.Several companies went too far in their marketing claims, however,according to the U.S. Food and Drug Administration's andFederal Trade Commission's warning letters focused on the claimed benefits of theproduct. One letter noted that the company sold CBD oil asa dietary supplement; "however, it cannot be a dietarysupplement because it does not meet the definition of a dietarysupplement," the letter advised. "FDA has concluded basedon available evidence that CBD products are excluded from thedietary supplement definition." In November, FDA issued a consumer update clarifying that the agency"is concerned that people may mistakenly believe that tryingCBD cant hurt'" while studies haveidentified possible effects on the liver, male reproductive healthand drug interactions.

Shook's Cannabis Lawpractice, led by Partners Katie Gates Calderonand Greg Wu,helped companies navigate the regulatory minefields of CBD andother cannabis-derived products. Shook also released a white paper,"Wild West or New Frontier? Global Cannabis MarketSpurs Legal Spend Across All Sectors," drawing on feedbackfrom in-house counsel in, among other sectors, health and wellnesscompanies.

Between beachfront jurisdictions banning chemicals that blockultraviolet light and scientific inquiries into the safety ofsunscreen found in the bloodstream, questions about the use ofsunscreen entered the mainstream in 2019. After Hawaii bannedoxybenzone- and octinoxate-containing sunscreens based on theirpurported effects on coral reefs in 2018, additional jurisdictionsfollowed suit, including Key West and the U.S. Virgin Islands. While Outside asked if sunscreen is "the newmargarine," focusing on the importance of vitamin D andsunscreen's role in preventing the skin from making its ownform, the U.S. Food and Drug Administration (FDA) set forth anupdated proposal for sunscreen regulations, includinga proposal to raise the maximum proposed labeled SPF to 60+ from50+, and reported that the agency was unable to deem 12 sunscreenactive ingredients as safe and effective due to a lack of research.A study published in May made headlines by imparting that sunscreen activeingredients can be absorbed into the bloodstream, but FDA emphasized to the public that absorptiondoes not mean the ingredients are unsafe and encouraged thecontinued use of sunscreen. The Personal Care Products Council proposed a work plan to provide safety datafor eight of FDA's questioned ingredients. Although the 2014Sunscreen Innovation Act set a deadline of November 26, 2019, for a finalrule on sunscreen, FDA's proposed monograph remains in draftform.

While some 2019 putative class actions focused on undeclared allergens or missing federal disclaimers, many plaintiffstargeted products that allegedly could not live up to the promisesmade in the marketing. Protein and muscle-building supplements werefrequently challenged, including for the omission of an essential amino acid resultingin an "incomplete protein." BPI Sports and Iovate Health Sciences USA, for example,allegedly sold protein dietary supplements that negatively affectedprotein synthesis, according to putative class plaintiffs.

"Natural" personal care products were also hit withlawsuits alleging they contained synthetic ingredients, includingTarte Cosmetics, Shikai hair and body care products and Thayer's Natural Remedies deodorants,wipes and dry-mouth sprays. Another lawsuit echoed a warning fromthe U.S. Food and Drug Administration about dimethylhexamine(DMHA), arguing that Hi-Tech Pharmaceuticals reformulated itssupplements with DMHA after federal regulations forbade the use ofa similar stimulant the company reportedly said would have the sameeffects as DMHA.

Plaintiffs also targeted skin care products for failing todeliver on promised anti-aging results, such as a putative classaction arguing L'Oral Revitalift is marketed asable to lift and firm skin or repair wrinkles without qualifyingthe benefits as helping "the appearance" of thosetargeted lines. Putative class actions also challenged whether biotin could benefit hair and skin, whether raspberry ketones could help consumers loseweight and whether a supplement can lower cholesterol.

A plaintiff asserted that a hair styling product could not feasibly bemarketed as "no flake" if it contained an ingredient witha "natural tendency to produce flaking," while anotherplaintiff argued that Vitamin Shoppe sells a daily supplementcontaining enough arsenic to harm daily users. S-adenosylmethionine (SAM-e) supplements werealso targeted, and one lawsuit alleged that Nature Medic Fucoidan products could causecancer cells to "self-destruct" and prevent cancer fromspreading in the body.

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United States: 2019: The Dietary Supplements And Cosmetics Year In Review - Mondaq News Alerts