Dietary Complement and Private Care Product Regulatory and Litigation Highlights – March 2021

Welcome to our curated selection of highlights of the regulatory and procedural developments in the dietary supplement and personal care product industry for March 2021. In case you’re wondering what pain relief, teeth whitening and CBD have in common (and who doesn’t?) It seems a year into the beginning the pandemic, the advertising battles will be fought in several forums. Continue reading…

National advertising department

NAD responded to some unique OTC drug superiority and comparison claims when it found that Hisamitsu America, Inc. supported its duration claims that Salonpa’s Pain Relief Patch Large “works for up to 12 hours” and “for up to 12 hours Provides relief. “However, NAD noted that comparative claims such as” All OTC pain relievers, including Voltaren, have one thing in common. None has proven to be stronger or more effective against pain than Salonpa’s Pain Relief Patch Large “and” only pain relievers marked for the relief of mild to severe, moderate pain “and” the most marked topical OTC pain reliever “were not substantiated and recommended that they be discontinued. This is an interesting discussion of comparative advertising for two FDA cleared products where the claims in question were outside of FDA clearances. Anyone who wants to understand how NAD is handling this jurisdiction issue should review this decision.

NAD broadened its already robust tooth whitening claims precedent by having the Colgate-Palmolive Company endorse claims that its Optic White Renewal toothpaste had “unparalleled whitening power,” “3% hydrogen peroxide,” and “most.” Hydrogen peroxide in a toothpaste for whitening. However, NAD recommended that Colgate abandon claims that their product “removes yellow stains for 10 years”. Colgate appeals to this recommendation.

Colgate’s advertising campaign for Optic White Renewal Toothpaste cleverly highlights some dubious fads of the past decade (jeggings and shake weights, anyone?). However, NAD’s concerns about Colgate’s justification for claiming 10 years of yellow stain removal was that Colgate did not consider negative control results on two NAD-agreed studies that were otherwise reliable. In relation to a third study, NAD raised concerns about its reliability in moving to a year-long calculation of yellowing. Many beauty and personal care companies are keen to provide claims of years of impact on their products. This case provides insight into what to consider for these types of claims.

With regards to dietary supplements, NAD has re-addressed the issue of energy claims related to vitamin B12 and recommended that Goli Nutrition modify its claim “Vitamin B12 to aid energy production” to make it clear that Goli relates to cellular energy and transmission of energy to avoid the impression that consumers who take their apple cider vinegar gums feel a noticeable increase in energy or become more energetic. “NAD also recommended that Goli discontinue claims that folic acid is beneficial for skin health as unfounded.


The FDA announced two warning letters to manufacturers of topical CBD products labeled as OTC drugs. In light of facility inspections that have identified significant manufacturing compliance concerns, the key takeaways in this round of CBD enforcement are as follows: The FDA does not believe that CBD is an appropriate inactive ingredient in OTC drugs , a position we do not believe the agency has previously publicly articulated. Additionally, the FDA reiterates a position the agency has previously claimed and disapproves of companies that use terms such as “FDA registered” to implicitly suggest agency approval. Read our blog post on these warning letters.

Process developments

At CBD, another CBD class action lawsuit was suspended pending the FDA lawsuit. This Dasilva complaint against Infinite Product Co. LLC (CD Cal.) Alleges that the FDA previously sent a letter to the defendant indicating that a variety of its CBD products were “unapproved new drugs” and “Incorrectly labeled drugs” are said to be in violation of the law on food, drugs and cosmetics, and that consumers would not have bought the defendant’s products if they had been aware of the misleading labeling. The court, along with a number of previous courts, upheld the defendant’s motion to remain under primary jurisdiction doctrine, noting that the FDA and Congress had separately expressed an interest in regulating the CBD and that it was unclear how the court would act The lack of clarity as to whether the products are drugs, dietary supplements or food was able to decide on the claims asserted by the plaintiffs. In particular, the court found that upcoming laws or regulations apply retrospectively and may inform the court of the merits of the dispute.

A judge in the Eastern District of New York has partially granted and partially denied a motion to dismiss claims against Bactolac Pharmaceutical, which manufactures the All Day Energy Greens supplement marketed and sold by co-defendant NaturMed, Inc., that the supplement for human consumption was unsure as Bactolac did not follow NaturMed’s contractual instructions by adding substandard ingredients. The court dismissed six breaches of warranty and consumer protection claims, but ruled that the remaining 15 claims must be discovered. The court also denied Bactolac’s motion to comply with plaintiffs’ request for punitive damages

Class litigation settlements

Reckitt Bensicker LLC agreed to resolve two parallel class action lawsuits (one in California and one in Illinois) alleging that the company was falsely promoting the health benefits of its “Move Free Advanced” glucosamine supplement. After four years of litigation, including being granted a class certification in June 2019 and denying the defendant’s motion to summarize the judgment in March 2020, the defendant agreed to pay $ 53 million to a statewide class of buyers that the plaintiffs identified as ” the largest “designated dietary supplement class action lawsuit” was ever reached. “The settlement provides for a cash refund for up to three purchases for a total of $ 66 ($ 22 per purchase) or up to a maximum of $ 225 for a variety of consumer goods at the option of the class member ($ 75 per purchase). Any funds remaining after all applications have been processed will be distributed to the Orthopedic Research Society in accordance with the Cy-Pres Doctrine. The settlement also provides that the named plaintiffs will receive up to $ 7,500 for attending and that the defendant would not object to the class attorney’s motion for attorney fees as long as the motion does not exceed $ 12.5 million. The plaintiffs’ application for preliminary approval is still pending.

Bayer Healthcare and Beiersdorf agreed to pay $ 2.25 million to settle a class action lawsuit in California alleging that their Coppertone mineral-based sunscreen products misled consumers into believing the products were only mineral-based when they actually contained chemical agents. Class members who submit proof of purchase may receive $ 2.50 per unit purchased with no restrictions. Consumers who do not provide proof of purchase may receive $ 2.50 per unit purchased, up to a maximum of four units per household. The settlement also provides that the named plaintiffs can apply for service awards of up to USD 5,000 each from the settlement fund, that the class attorney can apply for an attorney’s fee that does not exceed one-third of the total fund, and that the costs of notification and administration also come from the Fund up to a maximum of USD 530,000 plus postage to be paid. Any remaining funds will be paid out to the non-profit organization Look Good Feel Better. The defendants also agreed to end mineral-based labeling and other injunctive relief. A preliminary hearing for approval is scheduled for April 21, 2020.

New class actions / trends

A new alleged class action lawsuit has been filed in California State Court challenging “oil-free” claims related to various Smashbox cosmetic products. This filing follows a number of similar cases.

A number of new class action lawsuits have been filed in the southern borough of New York against Tom’s of Maine and Colgate Palmolive regarding their charcoal-activated toothpaste products. The complaints allege that Defendants’ products are marketed as contributing to “healthy gums” and provide “enamel-safe whitening” and “gentle cleaning” when they actually shave tooth enamel and gums and pose other safety risks. A similar lawsuit has also been filed in Missouri State Court against Proctor & Gamble.

Five new class action lawsuits were filed in the Northern District of California alleging that “maximum strength” or “maximum strength” lidocaine products contained 4% lidocaine, when most similar prescription patches actually contained 5% lidocaine. Three lawsuits have been filed against Sanofi-Aventis US LCC and two against Hisamitsu America Inc.

In March there was also an increase in class action lawsuits for pet products. Three lawsuits have been filed in California against Elanco Animal Health Inc. alleging that the flea and tick product Seresto contained pesticides and other ingredients that cause seizures, thyroid damage and the in the dogs and cats the products were marketed to Death caused other harm to humans. These filings followed a March report discussing the EPA’s failure to issue warnings about Seresto products.

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Thank you for coming back this month. See you in May!

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