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 may seem like eons ago from where we are sitting now, but the year began with the federal government in shutdown mode, and newspapers across the country were running articles with titles along the lines of “What does the FDA do and why does the shutdown matter?” Such articles may have caused some dismay among all of us food and drug lawyers, who feel like everyone should know what the FDA does (and should appreciate the work dedicated public servants at the agency do every day to keep consumers safe). But the shutdown that ended on January 25, 2019, certainly provided a teachable moment to explain the critical role of the agency to a wider swath of the general public.
The rest of 2019 continued to provide similar opportunities for FDA to teach the public and non-traditional stakeholders about some of the agency’s statutory mandates and how it balances benefits and risks in its regulatory decision-making. The rest of this post summarizes several (but certainly not all) ongoing challenges facing the agency in the consumer products space over the past year for which it both took significant actions and issued complementary informative statements designed for the general public. It’s also worth noting that advertising for all of these consumer product categories is subject to the oversight of the Federal Trade Commission (FTC), and in some cases FDA took its actions in conjunction with the FTC, increasing the level of public attention to the consumer protection issues the two agencies are confronting.
OTC Homeopathic Drug Products
In October 2019, after a slow build-up over the past few years (and an FTC enforcement policy for this industry that was issued in November 2016, which you can read more about here), FDA withdrew its 1988 Compliance Policy Guide on homeopathic drugs. The agency announced its determination that the 1988 policy was inconsistent with its current risk-based approach to enforcement in the area of unapproved drugs, reiterating that homeopathic drug products must be manufactured and labeled in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and agency regulations. Our prior post on this agency action is available here. We would expect to see an uptick in FD&C Act enforcement in the homeopathic drug space next year as a result of this significant FDA policy change.
Cannabis-Derived Ingredients Including Cannabidiol (CBD)
Former FDA Commissioner Scott Gottlieb issued a public statement immediately following enactment of the 2018 Farm Bill on December 20th of last year regarding how the agency would approach hemp-derived ingredients and products subject to FDA oversight. Dr. Gottlieb let the public know that although Congress had acted to remove hemp (as defined in the law) from the Controlled Substances Act, it had not amended the FD&C Act or FDA’s authorities over any prescription or non-prescription products. In April, as one of his last public statements before stepping down as FDA Commissioner, Dr. Gottlieb announced several new steps and actions taken by the agency “to advance [its] consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under [its] existing authorities.” Those steps included convening a public hearing on May 31, 2019 (see our post about the hearing here) and issuing a request for submissions to a public docket, which received over 4,000 written comments from the public, as well as creating a high-level internal working group to “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.”
Dr. Gottlieb also announced several Warning Letters that went to “companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations,” which happened several times during 2019 including in October when FDA and the FTC issued a joint Warning Letter to one such company (see each agency’s announcement here and here). The FTC has also taken solo action in this area based on the failure of such companies to have competent and reliable scientific evidence that their products can prevent, treat, or cure disease as conveyed by their advertising; an example of a solo FTC press release is available here. In addition to Warning Letters and coordinating enforcement activities with the FTC to maximize their resources, FDA has also been publishing educational materials for the public such as this page entitled "What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding."
Most recently, just before Thanksgiving, FDA made additional public announcements related to its ongoing work on this legally complex and politically challenging area, which we wrote about here. One of those actions was the issuance of another 15 Warning Letters to companies marketing unlawful CBD-containing products in different forms and for a wide array of uses. With the escalation of these kinds of enforcement actions over the course of the past year and FDA’s stated position that it does not have enough safety data on CBD and other cannabinoids to allow it to create a framework for the widespread use of these ingredients in all classes of consumer products, we expect much more to come in 2020. FDA’s announcements on unsafe or unlawful CBD-containing products have also begun to lead plaintiffs and shareholders to file class action lawsuits against marketers of such products, making it even more important for anyone who does business with these entities to conduct a robust diligence process that includes a comprehensive regulatory risk assessment.
Tobacco and Other Nicotine Delivery Products
Congress granted FDA authority over tobacco products in 2009 with the Family Smoking Prevention and Tobacco Control Act, which amended the FD&C Act. In mid-2016, the agency finalized regulations to extend those authorities to non-traditional tobacco products including cigars, hookah tobacco, and electronic nicotine delivery systems, or ENDS, which includes e-cigarettes. As recently as December 10, 2019, a three-judge panel of the U.S. Circuit Court of Appeals for the District of Columbia rejected arguments made by the ENDS industry that FDA’s final regulations are unconstitutional and that the agency violated the Administrative Procedure Act in developing them.
In addition to continuing to defend various tobacco-related actions in Federal court, FDA is also struggling to define its response to what the U.S. Centers for Disease Control and Prevention (CDC) calls “the e-cigarette epidemic among youth.” Although a discussion of those efforts and the political challenges associated with them is beyond the scope of this blog post, it seems fair to assume that anyone with even a tangential nexus to the health care industry recognizes the challenges FDA is facing related to these products. In 2019, the agency took some notable enforcement action in this area – including in partnership with the FTC – and it took every opportunity to issue consumer-facing statements to further educate the public about it, such as this one from July 2019.
However, ENDS are not the only tobacco products that FDA regulates and this year included some significant milestones under the new Tobacco Control Act authorities. In October 2019, the agency cleared the first-ever modified risk orders for eight snus smokeless tobacco products, which means that the products can be advertised with specific information about the lower risks of certain health effects using the products compared to smoking cigarettes. Then in mid-December, it authorized the sale of the first two reduced-nicotine combustible cigarettes, noting in its announcement of the action that this was the first company “to successfully demonstrate [to FDA] the potential for these types of tobacco products to help reduce nicotine dependence among addicted smokers.” FDA used that opportunity to further educate the public about the difference between a modified risk tobacco product application, which asks the agency for authorization to market tobacco products with specific claims about their reduced health risks, versus a premarket tobacco product application, which asks the agency for permission to sell the products. As with all agency announcements related to tobacco products, the statement included the important information for consumers: “While today’s action permits the new tobacco products to be legally sold or distributed in the U.S., it does not mean these products are safe or ‘FDA-approved.’”
We expect to see continued activity in 2020 from FDA both to educate consumers about its tobacco product authorities and to address the youth vaping epidemic in conjunction with other federal agencies like the FTC and the CDC.
More to Come: Legislative Outlook for 2020
Although all of the public health challenges summarized above that FDA has been grappling with all year will certainly continue to be high-priority areas in 2020, we are also watching closely for legislative changes that will require the agency to shift some of its focus towards implementing new authorities. Most notably, on December 10th, by a vote of 91-2, the Senate passed an OTC Drug Monograph reform bill (S. 2740) that coincides on major points – for example, on the inclusion of a user fee program and an 18-month marketing exclusivity period – with legislation approved by the House of Representatives last year. With OTC Monograph reform a bipartisan goal as well as an area that has had significant industry and advocacy group support for several years now (see our post on these efforts from 2017), and the House and Senate seemingly on the same page about how to modernize this long-neglected agency program, this may be a goal that gets done in 2020. If it does, it will bring significant changes to regulators and the OTC drug industry alike.
In a similar vein, cosmetic regulatory reform has been a long-standing priority for several members of Congress, and FDA leadership has been supportive of those efforts as well based on recent high-profile recalls and contamination incidents with cosmetic products that have shined more public light on the agency’s lack of authority over this industry. Most recently, the House Committee on Energy and Commerce’s Subcommittee on Health held a hearing on December 6th on this topic and heard from Dr. Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition, which (oddly enough) has responsibility for overseeing cosmetic safety today. Everyone, including members of industry, is in agreement that FDA’s authorities over cosmetic products are lacking and need to be modernized for today’s global marketplace, as this is one product category for which the FD&C Act has not been amended since its birth over 80 years ago. Some big issues still need to be ironed out, such as the scope of federal preemption of state cosmetic laws, but there may be momentum for cosmetic reform going into 2020 if political pressures allow for this to move forward. Other legislation that would affect cosmetic products, including a bill called the Natural Cosmetics Act that would create a Federal definition in the FD&C Act for the claim “natural,” has also been introduced in recent months, showing the increased attention policymakers are giving to the cosmetic industry more generally.
All in all, it’s never a dull moment for leadership at the FDA and it is sure to be an eventful 2020 with a brand-new, confirmed Commissioner. Dr. Stephen Hahn was confirmed for this job by the Senate on December 12th and was sworn in as the 24th Commissioner of Food and Drugs on December 17, 2019, just in time to take us into the New Year. We wish Dr. Hahn the best in his transition to this important role and also wish happy holidays to all of our readers!