Retail & Consumer Products

As the 2022 calendar year ended, the Consolidated Appropriations Act, 2023 was signed into law by President Biden. The massive piece of legislation included the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), comprising a long-awaited update to the nation’s cosmetic laws. MOCRA amends Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act). As noted by one of the bill’s co-sponsors, Senator Dianne Feinstein, after its passage, it finally brings the federal government’s “oversight tools” for cosmetics and personal care products “into the 21st century.”

Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts. Those looking ahead have raised concerns about women’s continued access to the wide array of birth control options that have been approved for use in the United States by the Food and Drug Administration (FDA). This post provides a brief historical background on how OTC birth control pills have been regulated under the Federal Food, Drug, and Cosmetic Act and reviews the FDA's Additional Conditions for Nonprescription Use (ACNU) Proposed Rule.

By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill, which was included as part of the Coronavirus Aid, Relief, and Economic Security Act that was signed on March 27, 2020 (see our prior posts here and here).

As we’ve reported previously, at the end of 2020, the Office of Non-Prescription Drugs (ONP) of the Food and Drug Administration (FDA), launched a webpage for its brand new user Over-The-Counter Monograph User Fee Program (OMUFA) – available here – published programmatic fee rates for Fiscal 2021 (which ended on September 30, 2021), and subsequently posted a public arrears list of facilities that did not make their FY2021 facility payments as was required to be done by May 10, 2021. Drugs produced by those in-arrears facilities are considered misbranded under the law.

A recent decision by the United States District Court for the Southern District of New York highlights directors’ fiduciary duty to evaluate all aspects of multi-stage transactions, including those portions to be effectuated post-closing by successor directors.

In early January, after referral by the CPSC to the Department of Justice (and probably the subject of an Acting Chair Adler public comment), fire extinguisher manufacturer Kidde reached a settlement with the government to pay a $12 million civil penalty for underreporting to the CPSC the scope and nature of defect, failure to report timely, making misrepresentations to the CPSC, and misusing a registered safety certification mark. The civil penalty seems to have signaled the start of a more aggressive approach to CPSC enforcement.

There’s a new class action trend consumer product companies need to be aware of that is not only causing additional stress when faced with a recall but also increased expense and adverse publicity.

California is the first state in the nation to ban certain ingredients – including formaldehyde, parabens, phthalates, per- and polyfluoralkyl substances (PFAS) and mercury – from cosmetics and personal care products. The Toxic-Free Cosmetics Act, signed into law by Governor Gavin Newsom on September 30, 2020, is aimed at chemicals often linked to cancer, reproductive harm, birth defects and endocrine disruption.

The food industry has been upended by the recent COVID-19 pandemic – restaurants and bars are scrambling to adjust to a new way of life after governors across America issued statewide “stay at home” orders in response to the coronavirus pandemic. Restaurants are now only permitted to serve take-out or drive-thru orders, and some restaurants have transformed themselves into neighborhood markets, or bodegas, selling food items not labeled for retail.

In the latest challenge to Section 6(b), Congressman Bobby Rush has introduced HR 5565, the Safety Hazard and Recall Efficiency Information Act, which would amend Section 6(b) by stripping it of its most basic due process, as well as increasing enormously the penalties for late reporting.

In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020. The website serves to streamline information regarding agriculture biotechnology products, which are regulated by FDA, USDA, and EPA. The implementation of the website is in response to the June 2019 Executive Order issued by President Donald Trump on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The Unified Website for Biotechnology Regulation complements prior joint actions such as the Coordinated Framework for the Regulation of Biotechnology, an Obama administration effort to reform the biotechnology regulatory process by enhancing transparency, predictability, and efficacy.

This is our third year-end post for 2019 related to the Food and Drug Administration (FDA), focusing on the agency’s activities in the widely divergent area of “consumer products.” (You can find our two prior posts on medical devices and prescription therapeutic products here and here, respectively.) In taking a wide-lens view of the past year, we see it as having presented a huge number of opportunities for the FDA to educate the public about its role in regulating non-prescription products sold directly to consumers. Most of the educational opportunities we highlight below came in concert with some other agency actions, like the issuance of Warning Letters to specific firms, but we’ve decided to cover only the key issues in the interest of keeping this post from turning into a long list of hyperlinks given the post’s already broad scope. Consumer products that fall within FDA’s jurisdiction include over-the-counter (OTC) drugs and OTC homeopathic drug products; tobacco and other nicotine delivery products; dietary supplements; foods and beverages for both humans and animals (technically, there is no such thing as an animal “dietary supplement”); cosmetics (sort of); and a wide variety of cannabis-derived consumer products that exploded onto the national landscape during 2019 and essentially cross into all of the aforementioned product categories.

It was confirmed that Commissioner Bob Adler was elected Vice-Chairman of the CPSC. Because there is no permanent CPSC Chairman at this time, Commissioner Adler will become the Acting Chairman of the agency until a permanent Chairman is confirmed. Commissioner Adler—a Democratic Commissioner—has served on the Commission since 2009.

In a press release this afternoon, Acting Chairman Ann Marie Buerkle announced that she would be withdrawing her nomination to be the permanent Chairman of the CPSC, as well as her nomination for an additional 7 year term, which would have expired in October 2025