FDA Issues Five Warning Letters to Makers of Knockoff GLP-1 Drugs

On December 17, 2024, the FDA published five (5) warning letters previously issued to makers of knockoff GLP-1 drugs. Four of the five warning letters were to companies (specifically, Xcel Research, Prime Vitality, Summit Research Peptides, and Swisschem) that claimed to distribute GLP-1s “for research use only” in spite of ample evidence to the contrary. The fifth, issued to Verony, was based on its manufacturing and distribution of oral GLP-1s that it falsely claimed were approved by FDA.

There should be no controversy or confusion about these warning letters. The companies which received them are not compound pharmacies, and therefore had no authority to manufacture or distribute these drugs based on the well-publicized shortage impacting the GLP-1 market. Thus, these products were not legitimate compounded copies authorized by federal law – they were simply knockoffs, as stated in the title of this article. Similarly, in spite of the fact that many GLP-1 drugs are approved by FDA, none of these companies had an FDA approval or, for example, a license to manufacture and distribute them from the drug companies that do. Ultimately, as FDA explains in the letters, these were simply adulterated, misbranded, unapproved new drugs.

Although the violations observed in the warning letters are easily understood, the letters reveal two important lessons that companies sometimes take too long to learn.

First, FDA can inspect a company without ever entering the company’s facility. Specifically, in each of these cases, FDA was able to observe serious regulatory violations based only on a review of the companies’ websites and social media posts. FDA routinely conducts similar, web-based inspections, which are well suited to reveal a product’s “intended use” – often the determining factor in whether a product is a “drug.” See 21 CFR § 201.128 (intended use can be derived from a broad array of “objective” factors, including “labeling claims, advertising matter, or oral or written statements.”) See also 21 USC § 321(g) (defining “drug” based on, inter alia, its intended use). Once FDA establishes the intended use, FDA can review its own records to determine that the company is not registered with FDA and/or has no drug approval, at which point the product is an “unapproved new drug.” Adulteration and misbranding violations follow in line, both of which are based on statutes carrying civil and criminal penalties.

Second, claiming that a product is for “research use only” – when in reality it is not – is no defense to otherwise clear regulatory violations. For instance, in each of the warning letters to Xcel Research, Prime Vitality, Summit Research, and Swisschem, FDA observed that the companies marketed their products as for “research use only,” but also observed from the companies’ websites and social media pages that the companies intended the products to be used by human patients. Again, FDA can establish a product’s intended use without stepping foot in a facility, and “research use only” disclaimers are easily overwhelmed by other publicly available evidence.

This is not a new phenomenon, and there are many prior examples of FDA running roughshod over similar “research” claims. For example, in this case, a Maryland man was criminally prosecuted for selling bodybuilding peptides with “research/laboratory use only” claims, which the government explained were used “as a ruse to avoid FDA scrutiny.” This case saw the same result, with the government explaining that the defendants “employed the bogus “research chemicals” disclaimer to conceal that they and others were distributing misbranded drugs and unapproved new drugs for use by their customers.”

Ultimately, GLP-1s are a relatively new phenomenon presenting many novel legal issues for FDA and stakeholders. These warning letters, however, pave no new ground, but should still be reviewed and understood by describing regulatory violations which companies are well advised to avoid.