Few people follow FDA enforcement closer than Asa Waldstein. His Apex Compliance platform serves the dietary supplement industry by tracking marketing language, granting him an up-close view on the latest FDA cases, something he showcases in a Warning Letter Wednesday series.

With dietary supplement brands developing food-based peptides and pushing the edges of claim regulations to align their products with synthetic drug peptides, Peptides Business Wire asked Waldstein about what he’s seeing as the two markets come together.

Let’s dig in.

Have you seen supplement companies exploring the peptides market?

We are also seeing companies develop products around peptides from familiar food sources. GNC has incorporated PeptiStrong, a fava bean-derived peptide ingredient, into its Beyond Raw Dynamic Whey. Ingredient suppliers are exploring other applications as well, including a brown-rice peptide ingredient that Nuritas markets for sleep support. These are examples of the supplement industry exploring peptides beyond the injectable treatments getting so much attention.

From a regulatory perspective, “peptide” is not a permission slip to enter the supplement market. The questions are whether the specific substance qualifies as a dietary ingredient, whether it is reasonably expected to be safe at the proposed dose, and whether a new dietary ingredient notification is required.

I think there is an interesting opportunity to develop well-supported dietary peptide ingredients. But I would encourage companies to understand the regulatory basis for the ingredient they are buying, rather than assuming that because another company sells it, the questions have already been answered. “Someone else is selling it” is useful market research, but not a regulatory strategy.

How closely is FDA watching?

FDA seems to be focusing much of its 2026 enforcement action on compounded GLP-1 online sellers (55 warning letters in 2026), and a major FDA concern appears to be companies suggesting their products were FDA-approved or equivalent to approved medications.

FDA has also sent at least 11 warning letters this year to peptide sellers claiming “research use only” on their product packaging, when in fact they are clearly for human use, and sometimes human-injectable use. FDA seems to be investigating these “research only” claims, such as in one letter where it followed links to a community forum and cited peptide dosing cheat sheets. This is a good reminder that FDA will review more than the product label.

The BioDrive letter I recently covered in Warning Letter Wednesday adds another angle. This is labeled as a dietary supplement, and FDA said the company submitted two new dietary ingredient notifications, received safety objections involving potential toxicity, and marketed its peptide-containing supplement anyway. Becuase the company was marketing a product that apparently lacked solid safety data, FDA considered the product adulterated. This was a dietary-supplement safety case, not the usual research-peptide seller letter.

What legally compliant opportunities do you see for supplement companies arising from the growth of peptide therapy?

I see two areas worth exploring.

The more immediate opportunity may be supporting the nutritional needs of people interested in these protocols, rather than to try to sell peptide treatments themselves. I would focus on protein intake, muscle maintenance, and addressing nutritional gaps with products that haveclaims supported by good science. There is room for thoughtful product development and consumer education here, but supporting someone’s nutritional needs is different from claiming a supplement makes their peptide treatment work better.

I would be particularly careful with “peptide support protocols.” The idea may have commercial potential, but saying a supplement enhances a drug’s therapeutic effects or treats its side effects can create drug-claim problems and calling something “support” does not necessarily solve that. It will be interesting to see if FDA takes a softer approach to this, as they seem to have done with GLP-1 support protocol marketing.

The longer-term opportunity is developing eligible dietary peptide ingredients with a well-supported safety package. The new dietary ingredient (NDI) pathway can be relevant, but the ingredient must first qualify as a dietary ingredient and not be excluded because of its drug-approval or investigational history. Being made from amino acids is not, by itself, the whole regulatory analysis. The specific ingredient, how it is manufactured, and its proposed conditions of use all matter.

When a new dietary ingredient notification (NDIN) is required, companies need to submit it at least 75 days before marketing and have evidence supporting safety under the proposed conditions of use. Filing the notification does not, on its own, establish safety or make the product lawful.

Should supplement companies take confidence from RFK Jr.’s pro-peptide positions and the July advisory committee recommendations?

I can understand why legitimate compounding pharmacies would view these developments with some cautious optimism. Secretary Kennedy has expressed support for broader peptide access, and the July advisory committee recommended several of the peptides it reviewed for inclusion on the 503A compounding list, which is a good policy signal.

However, I would still suggest caution. An encouraging policy direction is obviously not permission to sell a particular product as advisory committee recommendations are non-binding and do not, by themselves, change the compounding rules.

For supplement companies, I would be even more careful about drawing conclusions from these developments. Pharmacy compounding and dietary supplements operate under different legal frameworks. A favorable policy development for compounding pharmacies does not automatically make the same peptide a lawful dietary ingredient.

I think the takeaway is that the regulatory environment may be becoming somewhat more receptive to certain peptides, but supplement companies still need to evaluate each ingredient independently under the dietary supplement framework. I would view the policy direction as interesting and potentially encouraging, but not as a shortcut around the underlying regulatory requirements.