Peptide NDI Safety Concerns Lead to Warning Letter

Peptides!!! This company submitted two new dietary ingredient notifications (NDINs) for a peptide ingredient in its GLP-1 biomimetic supplement. In both responses, FDA raised safety objections, and according to the warning letter, the company marketed the product anyway. This is an interesting one.

This is the labeling according to the warning letter

• Saccharomyces cerevisiae S288C EV-1 Peptide

At first, I wondered whether EV1-Peptide was just Saccharomyces cerevisiae with a more exciting name in the SFP but according to the company’s patent application, the yeast is genetically engineered to produce a novel peptide. This leads me to think it is not a standard nutritional yeast with a fancy name.

Interestingly, FDA recognizes the ingredient as a dietary ingredient. This letter does not allege that the product is an unapproved drug because of disease claims or that it contains an undeclared drug ingredient. Instead, FDA found the safety information inadequate, identified potential toxicity concerns, and considered the supplement adulterated. This distinction is important.

From warning letter. “You proceeded to market Evolv GLP-1 Biomimetic despite FDA’s objections due to safety concerns.”

Asa comments: I do applaud this company for going through the NDIN process. There is time and expense involved, and some fly-by-night companies do not bother. However, submitting the notifications and addressing the safety concerns are different things.

I went down a rabbit hole last night looking at the product’s website, and the claims are bold. For example, one video testimonial calls it an “over-the-counter GLP-1,” and another says “no harmful side effects.” These are claims I would be very cautious about, especially in light of FDA’s safety concerns.

I believe the NDIN process provides a good structure for evaluating safety before products reach consumers, but my pessimistic side wonders: if this company had never submitted either NDIN, would FDA have found them in the sea of peptides being sold as supplements?

This is not to suggest that companies should avoid submitting well-researched NDINs. Submitting a notification and addressing FDA’s safety concerns are different things. But I would also like to see more safety-focused enforcement against companies that never submit required notifications.

I welcome more “where is the safety evidence?” warning letters. Companies doing the work should not feel they are drawing extra scrutiny while others avoid the process altogether.

What do you think?

Read the warning letter.