James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Axios, in “Supplement Makers Try to Latch On to GLP-1 Boom,” by Maya Goldman. (Read the full version – subscription required.)
Following is an excerpt:
Some supplement companies are vying to get into the booming GLP-1 space, adding a new layer of complexity to accessing anti-obesity treatments.
Why it matters: GLP-1s are expensive and in short supply. Supplements promoted with similar claims may be easier to come by, but experts warn they don't have to meet the same regulatory requirements and likely will never be as effective. ...
Yes, but: Supplements aren't subject to the same level of oversight as pharmaceuticals.
- GLP-1 drugs are put through three phases of clinical trials to prove safety and effectiveness before the FDA allows them to be sold. The agency also monitors safety concerns once they're on the market.
- Supplements, on the other hand, are regulated through the FDA's food apparatus.
- They're supposed to use ingredients that are already found in the food supply, and aren't tested or reviewed by the FDA before they come to market. There also aren't effectiveness standards for the products, said James Boiani, a lawyer at Epstein Becker Green specializing in FDA law.
- Supplement manufacturers are allowed to make health benefit claims about their products if they're substantiated — but the FDA generally doesn't approve supplement claims before a product launches, per the agency. ...
What we're watching: Many of President-elect Donald Trump's picks to run federal health agencies are vocally pro-supplement. That's likely to create an even more favorable environment for the weight-loss supplement market.
- Boiani expects the next administration to give supplement manufacturers even more latitude to tout purported health claims of their products, provided they're using safe ingredients, he said.
