The novel Coronavirus and the response by federal and state government agencies has been unprecedented in its nature and scope. This is certainly true for the manufacture and sale of dietary supplement products. Below, we summarize some of the regulatory actions taken in response to the pandemic.
FDA Suspends Plant Inspections
The Food and Drug Administration (FDA) has suspended all routine plant inspections amid the COVID-19 disease pandemic caused by the severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2). The FDA explained its decision as being essential to the safety of its own inspection teams, and in reaction to manufacturing plants prohibiting visitors to prevent spread of the virus. The FDA’s announcement that it was temporarily postponing routine inspections of facilities that produce food, medical devices, pharmaceuticals, cosmetics, veterinary products and other products came one week after it suspended foreign inspections.
FDA Commissioner, Stephen Hahn, MD, said manufacturers should continue to follow cGMPs, even if they are not being inspected: “Inspections are just one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA-regulated products; however, inspections are not what cause quality to happen. Safety and quality need to be owned by the industry, and firms have the primary responsibility to reliably produce quality products.”
The move clearly places the great responsibility of safety assurance on the manufacturers. Food and dietary supplement industry companies should devise solid standard operating procedures, while acknowledging a new imperative to adapt as market and regulatory conditions will likely continue to change at a breakneck pace.
COVID-19 Warning Letters
The FDA has issued a series of more than 30 warning letters this month on dietary supplement products marked to cure or prevent COVID-19. The FDA determined these products are unapproved new drugs sold in violation of section 505(a) of the Food, Drug, and Cosmetic Act (FDCA), and are misbranded drugs under section 502. The introduction or delivery for introduction of these products into interstate commerce is prohibited under FDCA section 301(a) and (d).
For example, the FDA sent a warning letter to the host of Infowars.com, Alex Jones, who offers supplements for sale, including “Superblue Silver Immune Gargle,” “SuperSilver Whitening Toothpaste,” “SuperSilver Wound Dressing Gel” and “Superblue Fluoride Free Toothpaste.” Infowars asserted that the silver products would treat or prevent the viral infection. One example the FDA cited was a YouTube video embedded on the Infowars.com website titled “Coronavirus – Is This The Virus that DIDN’T Cry Wolf?” The video went on to say that: “If you are concerned about the Coronavirus or the Flu or the common cold, then I recommend you to go to the Infowars store, pick up a little bit of silver that really acts its way to boost your immune system and fight off infection….” While the examples included were posted in February and early March, the FDA did not send a warning letter until April 9.
The warning letter also stated that:
FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products.
Finally, the warning letter said that it is unlawful under the Federal Trade Commission Act to advertise that a product can prevent, treat, or cure human disease without having competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the Infowars products. Any coronavirus-related prevention or treatment claims regarding such products are not supported by competent and reliable scientific evidence. The FDA warned Infowars to immediately cease making the prohibited claims.
Other recent examples include FDA warning letters sent to companies whom advertised that supplement products containing copper killed Coronavirus and that certain Chinese herbs could decrease the virulence of COVID-19 infections.
State Attorneys General Cease and Desist Letters
State AGs are also sending cease and desist letters to companies selling supplements to treat or prevent COVID-19. For example, Infowars received such a letter from New York Attorney General Letitia James. The letter ordered the company to stop selling the silver based products. The letter noted that while Infowars represented that its Superblue Toothpaste product “kills the whole SARS-Corona family at point-blank range”, there is FDA-approved vaccine to prevent the disease or treatment to cure it and the World Health Organization has also said that there is no specific medicine to prevent or treat this disease.
FTC Chairman Outlined the Agency’s Approach to Safeguarding Consumers during the Coronavirus Pandemic
The Chairman of the Federal Trade Commission, Joe Simons, issued a statement on March 26 outlining how the FTC intended to work to prevent consumer fraud during the Coronavirus pandemic. The statement said that, despite difficult circumstances, staff in the Bureau of Consumer Protection would remain at work. He went on to say that: “We are working closely with federal and state law enforcers, and with other stakeholders, including consumer advocates and the business community, and are devoting significant resources to tackling scammers and unfair and deceptive business practices. We will not tolerate businesses seeking to take advantage of consumers’ concerns and fears regarding coronavirus disease, exigent circumstances, or financial distress.” He also recognized that the pandemic was putting enormous strain on all sectors of commerce. Simons said that “[o]ver the next few weeks, the FTC will remain flexible and reasonable in enforcing compliance requirements that may hinder the provision of important goods and services to consumers. To be clear, by being flexible and reasonable, I am not suggesting that we will tolerate companies deceiving consumers, using tactics that violate well-established consumer protections, or taking unfair advantage of these uniquely challenging times. At all times, good faith efforts undertaken to provide needed goods and services to consumers will be taken into account in making enforcement decisions. The FTC is ready to assist businesses that may seek guidance about compliance obligations on consumer protection issues during this unprecedented time.”
Dietary supplement companies with legal questions regarding Coronavirus can contact Kevin M. Bell, Robert Durkin, or Richard J. Oparil.
Further information regarding the legal aspects of the Coronavirus pandemic, including government loan and business assistance programs, is available at AGG’s Coronavirus Resource Center at https://www.agg.com/news-insights/coronavirus.