In the current uncertainty over peptide regulation, a growing number of online sellers are marketing synthetic peptide products as “dietary supplements” when the active ingredients may not qualify as dietary ingredients under federal law. The line between a lawful supplement and an unapproved drug is determined by statute, not by what appears on the box, and the U.S. Food and Drug Administration (FDA) has made clear through enforcement actions that it will hold sellers, distributors, and practitioners accountable for getting this distinction wrong.
How Federal Law Distinguishes Drugs from Dietary Supplements
The Federal Food, Drug, and Cosmetic Act (FDCA) defines a “drug” as an article intended to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body. 21 U.S.C. § 321(g)(1).[1] The Dietary Supplement Health and Education Act (DSHEA) defines a “dietary supplement” as a product intended to supplement the diet with a vitamin, mineral, herb, amino acid, or other dietary substance. 21 U.S.C. § 321(ff).[2] A product is not both. If the active ingredient was not marketed as a dietary ingredient before October 15, 1994, and no accepted New Dietary Ingredient notification exists, the product may be treated by the FDA as an unapproved new drug regardless of its label.[3]
A second, independent basis for exclusion applies to ingredients with a clinical drug-development history. Section 201(ff)(3)(B) of the FDCA excludes an article from the dietary supplement definition where the article was authorized for investigation as a new drug for which substantial clinical investigations were instituted and their existence made public, unless the article was already marketed as a food or dietary supplement before that authorization.[4] The FDA has invoked this drug-preclusion clause to exclude NAC, NMN, and CBD from lawful supplement status, and the same analysis applies with equal or greater force to peptides that were the subject of IND-authorized human clinical investigations before appearing in supplement marketing.
Section 503A Compounding and the Category 2 Problem
Section 503A permits licensed pharmacists to compound drugs from bulk substances only if the substance has (1) a USP or NF monograph, (2) is a component of an FDA-approved drug, or (3) appears on the 503A Bulks List. 21 U.S.C. § 353a(b)(1)(A). Because the FDA has not finalized the list, it uses an interim enforcement policy.[5] Category 1 substances may receive enforcement discretion. Category 2 substances do not because the FDA has identified significant safety risks associated with those substances.
Several popular peptides fall outside established lawful compounding pathways. Kisspeptin-10 is Category 2. CJC-1295, AOD-9604, and GHK-Cu were removed from the interim list after nominators withdrew their submissions, and the Pharmacy Compounding Advisory Committee (PCAC) voted against adding them to the Bulks List. Withdrawal from Category 2 removes the formal significant-safety-risk designation, but it does not confer Category 1 status or Bulks List eligibility, and none of the three currently satisfies any of Section 503A’s three qualifying criteria. Absent a change in that status, these substances fall outside any established lawful compounding pathway and are not lawful dietary ingredients, though practitioners should confirm current classification before relying on this conclusion, as the FDA’s bulk-substance determinations continue to evolve.
Peptide Misbranding Violations and FDA Enforcement Actions
A dietary supplement label can itself create a misbranding problem when the ingredient is not a lawful dietary ingredient. Drugs and dietary supplements are misbranded if their labeling is false or misleading. 21 U.S.C. §§ 343, 352(a). A product labeled as a dietary supplement but containing, for example, BPC-157 or CJC-1295 may be deemed to be misbranded and may also violate the FDCA’s prohibition on introducing unapproved new drugs into interstate commerce.[6]
The FDA’s enforcement record reinforces the point. In the Precision Peptides prosecution, the FDA’s Office of Criminal Investigations pursued a seller that used “research use only” disclaimers, which the FDA described as “a ruse to avoid FDA scrutiny.”[7] The owner received house arrest and forfeited more than $2 million. More recently, the FDA has issued coordinated Warning Letters targeting entities that market unapproved drug products, including peptide sellers, compounding pharmacies, and telehealth companies.[8]
Why Healthcare Practitioners Face Enforcement Risk
The risk extends beyond manufacturers. The FDCA prohibits introducing, delivering, or receiving adulterated or misbranded drugs in interstate commerce.[9] A physician who buys these products wholesale and resells them from a clinic may become a distributor, and a practitioner who directs patients to a specific source may be viewed as promoting an unapproved drug.
Criminal penalties under 21 U. S.C. § 333 are tiered. A first-offense misdemeanor carries up to one year of imprisonment. A second offense or a violation committed with intent to defraud or mislead carries up to three years of imprisonment.
State boards may also investigate practitioners and facilities that sell, stock, or administer unapproved substances. The FDA often refers compounding violations to state boards of pharmacy, and Customs and Border Protection has intercepted large peptide shipments at the border.[10] These facts increase the risk that a clinic, medspa, or physician practice could face board discipline, licensing action, malpractice exposure, or referral for criminal investigation.
What Practitioners Should Do Now
The supplement label is not a shield. Practitioners should conduct an ingredient-level regulatory review before purchasing, recommending, or administering peptide products.
Confirm the regulatory status of each active ingredient.
Determine whether it qualifies as a dietary ingredient or can be lawfully compounded under Section 503A.
Request testing and manufacturing documentation.
Do not rely solely on the seller’s label or marketing claims.
Review seller communications.
Statements describing ingredients as “research use only” may increase enforcement risk.
Consult counsel before proceeding.
Peptide and supplement regulation continues to evolve.
How Frier Levitt Can Help
Frier Levitt’s FDA regulatory and healthcare compliance attorneys advise physicians, clinics, compounding pharmacies, and wellness companies on peptide and dietary supplement requirements, including ingredient classification, FDA enforcement risk, labeling compliance, and practitioner involvement in product distribution.
If you have questions about whether a peptide product you are selling or recommending complies with federal law, or if you have received a Warning Letter or inquiry from the FDA, contact Frier Levitt to schedule a confidential consultation.
[1] 21 U.S.C. § 321(g)(1).
[2] 21 U.S.C. § 321(ff).
[3] 21 U.S.C. § 350b; 21 C.F.R. Part 190.
[4] 21 U.S.C. § 321(ff)(3)(B); see also FDA guidance concluding that NAC, NMN, and CBD are excluded from the dietary supplement definition under this provision.
[5] FDA, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act (guidance).
[6] 21 U.S.C. §§ 331(d), 355(a).
[7] U.S. Department of Justice, press materials regarding United States v. Precision Peptides and FDA Office of Criminal Investigations statements concerning research-use-only disclaimers: https://www.justice.gov/usao-md/pr/owner-bodybuilding-drug-companies-admits-selling-misbranded-drugs
[8] FDA Warning Letters concerning unapproved drug products, including peptide-related products, compounding pharmacies, and telehealth companies: https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s
[9] 21 U.S.C. § 331(a), (d).
[10] FDA compounding enforcement materials and U.S. Customs and Border Protection seizure notices involving peptide shipments: https://www.cbp.gov/newsroom/local-media-release/cincinnati-cbp-foils-scheme-smuggle-over-5000-unapproved-peptides-us
