Retail & Consumer Products

On August 7, 2023, the Food and Drug Administration (FDA) published Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (the Draft Guidance), which provides much-needed clarifications to the registration and listing requirements that will soon apply to cosmetics companies under the Modernization of Cosmetics Regulation Act (MoCRA), for review and public comment. MoCRA was signed into law in December 2022 (see our prior post here) and added significant new provisions on cosmetic products to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under Section 607 of the amended FD&C Act, facilities that manufacture or process a cosmetic product for distribution in the United States must register with FDA and submit a cosmetic product listing, and the Draft Guidance answers basic and essential questions about who must register and list, what information must be included, and how to submit information to FDA. This post summarizes key takeaways from the Draft Guidance and discusses its implications as the December 29, 2023 initial registration and listing deadline approaches.

Homeopathic drugs have an unusual status in the United States. On the one hand, they are incorporated into the Federal Food, Drug, and Cosmetic Act (FD&C Act) within the definition of “drug,” which specifically includes articles recognized in the official Homoeopathic Pharmacopoeia of the United States (a historical perspective can be found in this ScienceInsider article from 2015, when government scrutiny was beginning to increase). But on the other hand, there is growing consensus that the effectiveness of such products is not supported by scientific evidence and that they are, in many cases, mere placebos that do not actually treat the patient’s medical conditions; in the worst cases, they contain harmful ingredients that may cause serious injury.

Since the late December 2022 seismic shift in the legal landscape for cosmetic companies – when Congress passed and President Biden signed the Modernization of Cosmetics Regulation Act, or MOCRA, into law (see our prior post here) – the Food and Drug Administration (FDA) has been relatively subdued in providing guidance to the affected industries regarding questions around “what happens next.” The most significant public announcements made by FDA since the law was passed are arguably that: (1) the voluntary cosmetic establishment registration program would be shuttered in favor of the yet-to-be-explained mandatory registration and listing system for cosmetic facilities; and (2) cosmetic manufacturers that want to report adverse events to the agency now should do so via the existing MedWatch program, which is currently used for drugs, biologics, and medical devices.

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive and diverse piece of legislation called the Food and Drug Omnibus Reform Act (FDORA). This latest addition to the rich history of amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes a variety of new and important changes to the laws governing therapeutic products and medical devices, clinical trials, and (in a much rarer occurrence) cosmetics and other personal care products. Many of the statutory changes had been requested by the Food and Drug Administration (FDA), whether formally via budget requests or more informally via its leadership. The agency also received an increase of $226 million (or 6.5%) in its congressional appropriation for fiscal year 2023 as compared to its funding level for fiscal year 2022, suggesting continued bipartisan support for its public health mission.  

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.

The U.S. Food and Drug Administration (FDA), industry, policymakers, and consumers share a common goal of ensuring that the foods and beverages Americans eat and drink are safe, and the law has long prohibited the adulteration of a food that “contains any poisonous or deleterious substance which may render it injurious to health.” As science and technology advance, so too does our collective understanding of what that famous statutory phrase from the Food, Drug, and Cosmetic Act should mean. Accordingly, FDA’s mission in overseeing the safety of the food supply is constantly subject to change. One excellent example of that is playing out in real time, because due to enhanced methods of detecting toxic elements in food, consumer interest groups and Congress have raised questions about FDA’s apparent lack of interest in looking for potential contaminants in our foods (even as available data show that the levels of some metals, like lead, have been in a general decline in the food supply as manufacturing also becomes more sophisticated and controlled and industry invests in better detection methods in the advancement of the shared goal of food safety).

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

On May 14, FDA announced that it issued five Warning Letters to companies that manufacture and market homeopathic drugs for human use. The letters all cite cGMP deficiencies relating to inspectional observations and conclude that the products are misbranded prescription drugs under the Federal Food, Drug, and Cosmetic Act because “in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs” and they are not labeled for prescription use only.

In 2019 so far, FDA has issued Warning Letters to eleven separate homeopathic drug manufacturers, including the five letters referenced above. All of the Warning Letters, except one, cite observations from inspections and focus on cGMP and quality violations at the manufacturing facilities, including contamination and varying amounts of active ingredients, that could lead to consumer harm.