The U.S. Food and Drug Administration (FDA) is issuing Warning Letters to companies selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure coronavirus disease (COVID-19).
We advise you to review your websites, social media platforms, product labels, and other labeling and promotional materials to ensure that your unlicensed, unapproved, and unauthorized products are not represented as safe and effective, for a COVID-19-related use.
The United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) will at some point review your corporate website, your social media platforms at www.facebook.com, www.linkedin.com, www.twitter.com, www.instagram.com, www.pinterest.com, www.youtube.com, as well as www.amazon.com, www.ebay.com, and learn that you market or distribute products in the U.S. to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
It is unlawful under the Federal Trade Commission Act (FTC Act), to advertise that a product can prevent, treat, or cure human disease unless you possess 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.
In order to market a drug that is also a biological product, a valid biologics license application (BLA) must be in effect under the Public Health Service Act (PHS Act).
The Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits, among other things, the introduction or delivery into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.
Misbranding applies to
- False or misleading information
- Lack of required information
- Conspicuousness and readability of required information
- Misleading packaging
- Improper packaging and labeling of color additives
This means that nearly all companies involved in interstate commerce, such as manufacturers, packers, distributors, and retailers, are responsible for assuring that they are not dealing in adulterated or misbranded products, even if someone else caused the adulteration or misbranding in the first place.
The law applies to components and packaging as well as to finished products. The Fair Packaging and Labeling Act (FPLA) requires specific label information. Violations of the FPLA result in misbranding.
FDA launched Operation Quack Hack in March 2020 staffed with a team of consumer safety officers, special agents and intelligence analysts that review thousands of websites, social media posts, and online marketplace listings. Following a preliminary investigation, the Operation Quack Hack team sends an abuse complaint to the domain name registrars or a report to online marketplaces.
Once illegally marketed products are identified, enforcement action would typically involve one or more of the following:
- taking down the websites
- requesting voluntary compliance
- a Federal Register notice
- issuing an untitled letter
- issuing a Warning Letter
- initiating a seizure, injunction, or other proceeding
Companies (establishments) that are involved in the production and distribution of medical devices intended for use in the United States, are required to register and list their products with the U.S. Food and Drug Administration, then renew their registration between October 1 and December 31, each year.
Before you export any drugs to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.
Manufacturers are also required to list their products and indicate all U.S. importers, annually.
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