In the wake of the global pandemic caused by the novel coronavirus, the U.S. Food and Drug Administration (FDA) has issued dozens of warning letters to various companies — including so-called 'affiliate marketers' — asserting that they have fraudulently marketed products that claim to prevent, treat, mitigate, diagnosis or cure COVID-19. These products include vitamin and mineral products, essential oils, colloidal silver, CBD oils and many others.
FDA Guidance
The FDA has stated that it has taken a number of steps to police
fraudulent products in order to protect consumers against scams and
the potential harm in utilizing ineffective products in lieu of
other preventative measures and treatments. Any product coming to
the FDA's attention is likely to result in the FDA publicly
ordering the company and/or its affiliate marketing partners to
correct the violations, including by ceasing the use of such
claims.
Background
If a product is intended to diagnose, prevent, treat, mitigate, or
cure a disease, the product is considered a drug by the FDA. Any
drugs considered to be new drugs, marketed or offered for sale in
the United States require prior approval from the FDA before being
sold to consumers. In contrast, nutritional or dietary supplements
do not require prior approval from the FDA, provided that the
marketing, packaging and sale of such products is compliant with
all applicable regulations.
Marketing Claims About Supplement Products in Relation
to COVID-19
Companies are not allowed to make marketing claims about their
supplement products in relation to COVID-19. Almost any supplement
product statement that explicitly refers to COVID-19 by name is
likely to result in the FDA categorizing the product as an
unapproved drug. Any such product would require specific approval
from the FDA before being marketed or made available for sale in
the United States.
For example, certain dietary supplements are able to be marketed with the claim that such products 'help support the immune system,' provided there is adequate scientific support that the product does, in fact, help support the immune system, and provided the product is in compliance with all other regulations (e.g., among other things, the product packaging must include the disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."). When such circumstances are met, FDA pre-approval is not required.
However, where a supplement product's marketing specifically refers to COVID-19, the otherwise permissible statement will now likely be considered to constitute an impermissible claim that the product can prevent, treat, cure or mitigate COVID-19.
Even if the supplement product does not specifically refer to COVID-19, and instead refers to the product's ability to treat the symptoms of COVID-19, such as shortness of breath, fever, or flu-like symptoms, the FDA will likely determine the product is a drug requiring approval from the FDA.
In the absence of FDA approval for a product to be used as a drug, a product making a claim that it can diagnose, prevent, treat, mitigate or cure COVID-19 (or any other disease) will, if scrutinized by the FDA, be deemed unapproved and/or misbranded.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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