Andrew Lustigman, Chair of Olshan's Advertising, Marketing & Promotions Group and Co-Chair of the firm’s Brand Management & Protection Group, and Claudia Dubón, a partner in the firm’s Corporate/Securities Group, published an article in New York Law Journal entitled “New Cosmetic Regulations Dramatically Changing the Compliance Landscape.” In the article, Andy and Claudia discuss the cosmetics labeling compliance requirements in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Several provisions took effect on July 1, including requiring facilities that process or manufacture cosmetic products to register with the FDA. The product label must also include the contact information of the responsible person(s) for facilitating the reporting of adverse events. “MoCRA is arguably the most significant expansion of the FDA’s regulation of cosmetic products in decades,” Andy and Claudia explain. “These requirements will apply to manufacturers and marketers (among other various parties in the cosmetic space), who will need to carefully consider their and their suppliers’ compliance obligations under these new regulatory requirements.” They add that more MoCRA regulations may be forthcoming, including good manufacturing practices (GMPs) for disclosing fragrance allergens in cosmetic product labeling and establishing and requiring standardized testing methods for detecting asbestos in talc-containing cosmetics. “Given the substantial and expanding compliance obligations, parties in the cosmetic space will need to be mindful of the enhanced regulation requirements to maintain compliance moving forward,” Andy and Claudia write.
Andrew Lustigman, Chair of Olshan's Advertising, Marketing & Promotion's Group and Co-Chair of the firm’s Brand Management & Protection Group, will speak on the panel “Food Marketing, Advertising and Promotion Essentials: Ensuring Claims Compliancy and Meeting Substantiation Standards Relative to Health, Nutrition, Structure and Function” as part of ACI’s Food Law and Regulation Boot Camp virtual conference on July 19, 2023, at 1:45pm (CT). The panel will explore the relationship between food product labels and advertising and promotion, how to distinguish ...
FTC’s Proposed New Rules for Businesses Selling Subscriptions Heighten Compliance Obligations, published in The New York Law Journal
* Rachel Gold is a law clerk in the Corporate/Securities Law practice group.
Following up on its action against other celebrities who have promoted crypto investments without disclosing their compensation interest, the Securities and Exchange Commissions (“SEC”) announced “unlawful touting” charges and Order against reality star Kim Kardashian for promoting a cryptocurrency on social media without acknowledging that she was being compensated for the post. This enforcement action is a reminder that it is not just the Federal Trade Commission (“FTC”) who is enforcing compensation disclosures on social media.
While many marketers of CBD products label such products as “dietary supplements,” the FDA has made clear that it rejects the designation under the current regulatory standards. The FDA’s recent pronouncement is consistent with its previously stated position that such products may not be marketed as dietary supplements because of a drug approval for the ingredient.
The Legal 500 published a Q&A authored by attorneys Andrew Lustigman and Morgan Spina, entitled “United States: Pharmaceutical Advertising”
Andrew Lustigman, head of Olshan’s Advertising, Marketing & Promotions Practice Group, was featured in a Companies Digest article comprising assessments by leading business law attorneys.
The U.S. Securities and Exchange Commission (the “SEC”) filed enforcement actions on May 14, 2020, against two unrelated companies, Turbo Global Partners, Inc. (“Turbo”) and Applied BioSciences Corp. (“APPB”). The SEC charged both companies with securities fraud based on alleged materially misleading statements that the companies were offering and shipping products to combat the coronavirus (COVID-19). These actions taken by the SEC are consistent with approaches taken by other regulators, including the Federal Trade Commission and Food and Drug Administration (the “FDA”), with regard to misleading statements made in connection with coronavirus-related products. On the whole, regulators appear to be particularly cognizant of businesses and individuals seeking to take improper advantage of the circumstances created by the global pandemic, and as such are taking action against such companies and individuals.
Andrew Lustigman, head of Olshan’s Advertising, Marketing & Promotions Practice Group, was quoted in a Bloomberg Law article on the coordinated attack on coronavirus scams led by The Justice Department (“DOJ”), the Federal Trade Commission (“FTC”), and the Food and Drug Administration (“FDA”). All three agencies have filed charges against and have sent warning letters to people and companies for advertising unapproved COVID-19 treatments or preventatives. Given the import that these efforts have to public health during the pandemic, the agencies’ attention is intensely focused on preventing coronavirus fraud, so while the DOJ is investigating a wide range of fraudulent activity, the FTC and the FDA are evaluating false claims about treatments and cures. “That intensity is shown by how quickly the agencies are taking cases to court and asking for orders to stop the fraudsters,” said Mr. Lustigman. Wasting no time, the DOJ has filed at least four civil lawsuits against people allegedly selling fraudulent cures/treatments, obtaining temporary restraining orders against three of the defendants. The FTC and FDA, meanwhile, have sent warning letters both to sellers of unapproved treatments and to multi-level marketing companies for unsubstantiated claims made by their independent distributors.
The FDA and FTC have issued joint warning letters to companies selling products that they claim are able to treat or prevent coronavirus. The regulators sent the first set of such warning letters to several companies on March 6, 2020 and have continued to send such warning letters since.
Happy holidays! As we enter a new year, Olshan’s Advertising & Branding groups share their list of current hot topics in advertising law. In no particular order (drum roll please), here is our top 10 list:
The U.S. Food and Drug Administration (“FDA”) has announced its intent to withdraw its Compliance Policy Guide 400.400 (1988) (“CPG 400.400”) for homeopathic drug products pursuant to which such products have been permitted to be marketed without having to comply with the new drug, adulteration and misbranding requirements that are otherwise applied to all drug products. Under CPG 400.400, homeopathic drug products were permitted to be manufactured and marketed without the FDA approval applicable to all other drug products. However, due to certain incidents involving improperly manufactured homeopathic drug products, in 2017 the FDA announced its intention to switch to a risk-based enforcement approach for unapproved homeopathic drug products.
As we have discussed in a prior post, the FTC and FDA have been involved in a joint effort to curb non-compliant labeling and/or advertising of e-liquids for use in e-cigarettes. For the most part, the agencies have been focused on protecting children and young people from the dangers of nicotine and tobacco products by cautioning manufacturers, distributors and retailers of e-liquid products against using labeling, packaging and/or advertising that resembles children’s food products, like juice boxes, candies or cookies.
The Food and Drug Administration (“FDA”) and Federal Trade Commission (“FTC”) have issued joint warning letters focusing on disease claims being made by dietary supplement marketers. In addition, the FDA announced new steps it is undertaking with a goal toward protecting the public from potentially harmful products and unapproved claims.
The recently enacted Farm Bill amends the Controlled Substances Act so that hemp and CBD products containing trace amount of THC are not classified as Schedule 1 controlled substances. While many are excited about this amendment, the law does not change FDA’s regulatory requirements for CBD-containing products under its regulatory jurisdiction.
The FDA and FTC together have recently issued 13 warning letters to manufacturers, distributors, and retailers, cautioning against the sale of e-liquids for use in e-cigarettes using labeling and/or advertising that is similar to that which is found on children’s food products, like juice boxes, candies, or cookies. The warning letters were sent in furtherance of the FDA and FTC’s efforts to protect young people from the dangers of nicotine and tobacco products.
With consumers ever more ingredient-conscious, brands must be careful of how they describe them, particularly when the product may be positioned as a “healthy” version.
What the FDA considers “healthy” remains a major source of contention. The FDA has started a public process to redefine the “healthy” claim on food labeling to update existing food choices which will hopefully bring clarity to the issue.
FDA regulations prohibit making drug claims for dietary supplement products even if such claims are supported by scientific evidence. A recent FDA enforcement action involving dietary supplement products promoted to address high cholesterol, hypertension, diabetes, depression and muscle pain claims show that the agency is prepared to take significant steps where manufacturers continue to make drug claims for dietary supplement products, particularly where the facility fails to meet CGMP requirements.
A Final Rule has been issued by the FDA amending its regulations for registration of foreign and domestic food facilities.
FDA issued letters to KIND, LLC over its use of the terms "healthy and tasty" in connection with its listing of product ingredients.
The creation of a new web-based tool for developers of health-related mobile apps.
Olshan Advertising, Marketing & Promotions Practice Group Leader Andrew Lustigman was extensively quoted in the Electronic Commerce & Law Report published by Bloomberg BNA addressing the outlook of social media advertising.
Brands must actively monitor the posts by social media influencers, particularly where there is a business relationship, either directly or indirectly, between them.
In the United States District Court for the Eastern District of New York, pharmaceutical sales representative Alfred Caronia was convicted of conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor.