The National Consumers League Calls on FDA to Determine No Clinical Need for Continued Mass Compounding of GLP-1 Weight Loss Drugs

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NCL’s Comment Letter in Support of FDA’s Proposed Rule to Exclude 3 GLP-1 Drugs from the 503B Bulks List Calls This Action “A Defining Moment” in Regulating Compounded GLP-1s

Washington, DC– At a time when poison control centers report a nearly 1,500 percent increase in calls since 2019 about overdosing and serious adverse events related to injectable compounded GLP-1 weight loss drugs, the National Consumers League (NCL) is calling on the Food and Drug Administration (FDA) to act with a sense of urgency in finalizing a rule that will establish “no medical or clinical need” for continued mass compounding of these medicines.

In a comment letter submitted to the federal docket supporting a proposed regulation to exclude the GLP-1 drugs semaglutide, tirzepatide, and liraglutide from the 503B Bulks List, NCL asserted that the rule, if implemented, would be a “a defining moment” in combatting the exploitative market selling untested, unapproved GLP-1 drugs, despite only covering the large 503B outsourcing facilities supplying compounded drugs to hospitals and clinics. This is because the rule will formalize FDA’s finding of no medical or clinical need for continued mass compounding of GLP-1 weight loss drugs, including so-called “personalized” compounded GLP-1 products with added ingredients such as vitamin B-12; drugs with different strengths and doses, such as microdosing; and GLP-1s with different routes of administration, such as sublingual or buccal, that have not been approved.

Additionally, it is NCL’s position that applying the determination of no clinical need to exclude the three GLP-1 drugs from the 503B Bulks List will change health professionals’ attitudes about recommending compounded GLP-s, drive more clinicians to follow medical treatment guidelines, and improve patient safety by reducing the availability of mass produced compounded GLP-1 drugs that were never intended to be marketed permanently.

“While FDA’s proposed rule is not a complete solution to stopping the deceptive marketing practices of telehealth platforms and other sellers promoting compounded weight loss drugs, a determination by FDA of no medical or clinical need for these products will be a gamechanger,” said Nancy Glick, NCL’s obesity policy lead. “The FDA should act swiftly to protect consumers from potentially serious health problems associated with compounded GLP-1 drugs.”

In support of this viewpoint, the NCL comment letter lays out these arguments, all of which underscore the importance of finalizing the proposed rule to help ensure the safe use of GLP-1 drugs:

  • Compounded drugs are not as safe as the FDA-approved versions because they may contain the wrong ingredient or no active ingredient at all, or they may contain too much or too little of the active ingredient. Additionally, “personalized” GLP-1s mixed with additives like vitamins, or sold as microdoses, have not been evaluated for safety or effectiveness in clinical trials.
  • GLP-1 weight loss drugs require medical oversight, which necessitates having a detailed label with information on eligibility criteria, indications and usages, dosage and administration, dosage forms and strengths, and warnings to ensure safe use. Compounded versions are exempt from this requirement, putting consumers’ health at risk.
  • The supply chain for compounded GLP-1 APIs is unreliable. Patient safety experts have warned that the source of the active pharmaceutical ingredients (API) used in compounded GLP-1s is often from China, where quality standards can vary widely and the API may go uninspected.
  • Because deceptive advertising hinders the ability of consumers to be aware of safety risks, consumers are unprotected from the deceptive marketing of unapproved GLP-1 weight loss drugs. As a result, thousands of Americans have experienced serious health problems related to dosing errors and reactions to harmful ingredients in compounded GLP-1 products.
  • Despite the argument from opponents that excluding the three GLP-1 drugs from the 503B Bulks List will eliminate an affordable alternative for patients, NCL counters that the alarming reports of dosing errors, overdoses, and serious reactions to harmful ingredients in compounded GLP-1 products is evidence that price should not be a factor when implementing rules affecting patient safety.

NCL’s comment letter is available here.

About NCL
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.