Against the backdrop of a change in administration and a pandemic, most discussion of the Food and Drug Administration has focused on the selection of a commissioner, vaccine approval, and managing the safety of food and drug products amidst global shortages.
But a review of this summer’s legislative agenda illuminates efforts to transform the agency’s authority, as well as the food and cosmetic products we see on shelf post-pandemic. Specifically, efforts focus on the FDA’s policy on the use of cannabis in conventional food and dietary supplements and the expansion of FDA authority over cosmetics.
Proposed federal cannabis and cosmetic legislation reflect efforts that would greatly change the FDA’s regulation of conventional food, dietary supplements, and cosmetics, and are important reminders of the role the legislature can play in addressing concerns over FDA authority. The question now, is which concern—consumer access to CBD or cosmetic safety—will be addressed first?
Regulating Cannabis in Conventional Food and Dietary Supplements
With the explosion of CBD “edibles,” there has been a concerted push for the FDA to expand its limited view of its authority over cannabis, including its two most-known compounds delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
The FDA’s current position is that, generally, marketing food or dietary supplements containing THC or CBD in interstate commerce violates sections 201(ff)(3)(B) and 301(ll) of the Food, Drug and Cosmetics Act (FD&C Act). The FDA recognizes that it has the authority to grant exceptions by issuing a regulation permitting the use of a pharmaceutical ingredient in a food or dietary supplement.
For example, in December 2018, the FDA issued generally recognized as safe (GRAS) notices for three hemp seed-derived ingredients, allowing these ingredients to be added to human food. In August, however, the FDA objected to two new dietary ingredient (NDI) notifications for full-spectrum hemp extract containing CBD, renewing pressure for Congress to provide the FDA with explicit authority over cannabis products.
VIDEO: How do states legally get around the federal ban on cannabis, and what unique legal challenges do attorneys and businesses in the marijuana industry face?
Congress is considering two different approaches to expanding the FDA’s authority to regulate cannabis in dietary supplements and food.
First, it is considering targeted amendments to the FD&C Act, which address the FDA’s objections under sections 201(ff)(3)(B) and 301(ll) of the act. For example, the Hemp Access and Consumer Safety Act (S. 1698) would allow for hemp-derived CBD in both food and dietary supplements, while the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021 (H.R. 841) is limited to dietary supplements only. These proposals, generally, have bipartisan support.
The second approach goes further by creating a new regulatory framework for cannabis products within the FDA. The Senate Democratic leadership proposed this in the Cannabis Administration & Opportunity Act, a comprehensive cannabis reform bill floated this summer. Title V would create a “Center for Cannabis Products,” which would have jurisdiction over nearly all FDA-regulated products that contain cannabis (except drugs).
Although the draft bill would not permit cannabis in dietary supplements, cannabis products could bear “structure/function claims” that describe the role of a cannabis constituent intended to affect the normal structure or function of the human or animal body. This proposal’s partisan nature, as well as intraparty divisions on cannabis reforms, present obstacles to passage.
Regulating Cosmetics Safety
In contrast to Congressional efforts to bypass the FDA’s current regulatory approach toward cannabis, other Congressional activity is intended to further empower the agency to actively regulate cosmetics.
For example, even though the FDA cannot compel manufacturers to register with the agency or report adverse events, the FDA has established a Voluntary Cosmetic Registration Program and encourages companies to report adverse events to the Center for Food Safety and Applied Nutrition (CFSAN).
Additionally, during a 2019 hearing before the House Energy & Commerce Health Subcommittee, CFSAN Director Susan Mayne recognized the “rapid evolution” in the cosmetics industry and expressed a willingness to work with Congress to expand the agency’s authority.
This summer, leading members in both chambers introduced legislation that would strengthen the FDA’s authority over cosmetics. On June 17, Sens. Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) reintroduced the Personal Care Products Safety Act (S. 2100). This bill would require manufacturers to register with the FDA, report serious adverse events, and maintain certain records. It would also require the FDA to issue current good manufacturing practices for cosmetics, as well as authorize the agency to seize counterfeit foods.
On July 29, Energy & Commerce Subcommittee on Consumer Protection and Commerce Chair Jan Schakowsky (D-Ill.), introduced the Safer Beauty Bill Package. The package consists of four bills that focus on increasing transparency of the ingredients in cosmetics and personal care products.
Schakowsky has not yet reintroduced the Safe Cosmetics and Personal Care Products Act, a broad-ranging cosmetics reform bill which she has introduced during nearly every congressional session since 2010.
While cosmetics safety legislation passed the Energy & Commerce Health Subcommittee during the 116th Congress, there has not been any committee action during the 117th Congress. Several issues remain unresolved—making passage unlikely in the near-term—including whether to preempt existing state laws and potential burdens on smaller manufacturers.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
Raqiyyah Pippins is a partner at Arnold & Porter who focuses on the FDA’s regulation of food, dietary supplement, cosmetic, drug and medical-device products sold directly to consumers, as well as FTC and state regulation of the marketing and sale of consumer products. She co-leads the firm’s Consumer Products & Retail industry group.
Pari Mody is a senior associate at Arnold & Porter who counsels clients on legal and policy matters related to health-care and FDA-regulated products, including pharmaceuticals, medical devices, foods, dietary supplements, and cosmetics.