The number of cases of SARS-CoV-2 corona virus infection, and COVID-19, the disease caused by virus, continues to increase in the United States—both in number and in location (real-time map). At the same time, the number and severity of symptoms post-infection can vary by age and other risk factors (CDC Report). High level politicians have been reported to be infected by, hospitalized for, and recovering from the virus. And there is no U.S. Food and Drug Administration (FDA) approved or licensed cure for COVID-19 (other than time, supportive measures as necessary, and a healthy immune system). "Although there are investigational COVID-19 vaccines and treatments under development, these investigational products are in the early stages of product development and have not yet been fully tested for safety or effectiveness."
Against this backdrop, consumers would like to avoid contracting COVID-19, and if that fails, are looking for treatments that might be effective to lessen the severity or duration of the disease. Some companies are offering products with unproven claims related to treating or preventing COVID-19. Consumers are buying these products, and for a variety of reasons, are reporting the companies and their products to the FDA and the U.S. Federal Trade Commission (FTC). The FTC recently posted a data summary indicating that the agency has received over 18,000 COVID-19 related complaints, amounting to over $13.4 million in total fraud, costing each consumer on average over $557.
Not surprisingly, the FTC and the FDA have recently issued about 30 warning letters to companies making, among other things, ingestible, inhalable, and device products that are improperly indicated for treating COVID-19. The products can harm people (or animals) in several ways. Some of the products are dangerous if used as directed. Others may deter consumers from timely seeking medical attention.
An example of a product that falls under the dangerous if used as directed (warning letter) is "for chlorine dioxide products indicated for treating or preventing COVID-19 in adults and children." This is especially concerning "since children are a vulnerable population that may be at greater risk for adverse reactions from consuming chlorine dioxide." Chlorine dioxide is used, for example, for bleaching paper and disinfecting swimming pools, and can decompose "extremely violently" when "separated from diluting substances" such as water.
The FDA notes that ingestion of chlorine dioxide can induce significant adverse events including:
- Respiratory failure caused by a serious condition where the amount of oxygen carried through the blood stream is greatly reduced (methemoglobinemia);
- Changes in the electrical activity of the heart (QT prolongation), which may lead to potentially fatal abnormal heart rhythms;
- Life-threatening low blood pressure caused by dehydration;
- Acute liver failure;
- Low blood cell counts, due to the destruction of red blood cells faster than the body can make it (hemolytic anemia), which required a blood transfusion;
- Severe vomiting; and
- Severe diarrhea.
The agency's warning letter "request[s] that the seller take immediate action to cease the sale of such unapproved and unauthorized products for the cure, mitigation, treatment, or prevention of COVID-19."
An example of a product that may delay consumers from timely seeking medical treatment is a CBD containing product (warning letter). The use of CBD in dietary supplements and foods and beverages, is an area of regulatory tension for the FDA. However, when CBD containing products are marketed as unapproved drugs for treating COVID-19, the agencies will act. In this case, the vendor made claims for treating COVID-19 associated inflammation with a CBD containing product, as evidenced by the following advertising copy:
Unless you are living in a cave, you know what Corona Virus is … Some medical researchers are finding the disease effects the lungs … Inflammation is the problem here … We have been saying on our blog since the beginning about the powerful anti-inflammatory effects of CBD … CBD has been found to decrease inflammations naturally, and through communicating with your endocannabinoid system.
Other examples of COVID-19 product violative claims include:
A kit indicated for increasing immunity and protecting against COVID-19 virus;
An air purifier advertised to be scientifically proven to efficiently prevent the spread of air-borne viruses;
A food indicated for preventing COVID-19; and
A dietary supplement indicated for slowing or stopping the coronavirus with high doses of vitamin C.
At least three take-aways emerge from the warning letter list. First, that a broad range of products—for dietary supplements to devices—are improperly being indicated for treating and preventing COVID-19 infections.
Second, that in some cases, the genesis of some of these improper indications may be press reports or clinical trial postings (see, for example, this posting for a to-be-run COVID-19 vitamin C clinical trial, or this article indicating that vitamin D may play a role in treating COVID-19). Dietary supplement manufactures should understand that anecdotal evidence, medical speculation in the press, or an unfinished clinical trial, do not provide basis for making such claims.
Third, and importantly for all manufacturers, that the FDA and FTC are stepping up their enforcement actions against products indicated for treating or preventing COVID-19 infections. Along these lines, the agencies have required that the companies and their products who are the subject of warning letters "take immediate action to correct the violations …" including reviewing websites, product labels, and other labeling and promotional materials" to ensure you are "not representing your products for a COVID-19 related use" for which they "have not been approved by FDA." Failure to "immediately correct the violations … may result in … seizure and injunction."
Conclusion
Because of unique socio-economic circumstances of the COVID-19 pandemic, and conflicting anecdotal press reports on efficacy of various products for treating COVID-19, we expect to see the agencies issue more joint warning letters. Consumer goods and dietary supplement companies should carefully scrutinize any claims that are, or could be interpreted as being, related to the treatment and prevention of COVID-19. Companies should also refrain from generating COVID-19 claims based on conflicting or anecdotal press reports or clinical trial postings. Seeking the advice of counsel when responding to a COVID-19 related warning letter, or when contemplating new product claims, is also strongly recommended.
