Regulated and Restricted Actives in Oral Films: Status Guide

Why StripWorks publishes a status page

A meaningful share of the inquiries an oral film manufacturer receives are for actives that cannot be sold as dietary supplements at all, or only under a drug or tobacco pathway. Answering each privately wastes the buyer's time and ours; answering vaguely invites a project that dies at scoping. So this page says, active by active, what FDA has stated, what that means for a supplement strip, and where StripWorks draws its line.

FDA positions are cited from fda.gov, the statute, and the regulations. Where a status has moved, the page says so. State law, which matters for hemp cannabinoids, kratom, and nicotine, is outside these sources, and none of this is legal advice. Our own rule is simple: we do not quote drug-pathway or excluded actives as dietary supplement strips. That is a scope decision, not a verdict on an ingredient's merit or a forecast of where regulation goes.

How the classification test works

Two definitions decide most of the rows below. Under 21 U.S.C. 321(g), a drug includes any article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and any article other than food "intended to affect the structure or any function of the body." Under 21 U.S.C. 321(ff), added by DSHEA in 1994, a dietary supplement is a product intended to supplement the diet that contains a dietary ingredient, is intended for ingestion, is not represented as a conventional food, and is labeled as a dietary supplement.

The same section carries the drug-exclusion clause: a dietary supplement does not include an article approved as a new drug, or authorized for investigation as a new drug where substantial clinical investigations have been instituted and made public, unless the article was marketed as a supplement or food before that. Whichever use came first controls. This is the basis of FDA's CBD position, it was the basis of the NMN dispute, and it is why prescription peptides cannot be supplements.

Two more filters apply. An ingredient that is not a vitamin, mineral, botanical, amino acid, or dietary substance is not a dietary ingredient no matter how it is marketed. And a dietary ingredient not marketed in the U.S. before October 15, 1994 is a new dietary ingredient needing a 75-day premarket notification under 21 CFR 190.6.

CBD and hemp cannabinoids

FDA's position is explicit. Asked in its cannabis Q&A whether CBD can be sold as a dietary supplement, the agency answers "No," stating that "FDA has concluded that THC and CBD products are excluded from the dietary supplement definition" under section 201(ff)(3)(B), because CBD is the active ingredient in an approved drug (Epidiolex) and substantial clinical investigations were made public before CBD was marketed as a food or supplement. The same page says it is prohibited under section 301(ll) to introduce into interstate commerce any food to which CBD or THC has been added, and FDA's ingredient directory files CBD under "Excluded from dietary supplement definition."

On January 26, 2023, FDA went further, announcing that "existing regulatory frameworks for foods and supplements are not appropriate for cannabidiol," denying three citizen petitions that asked it to allow CBD in supplements, and saying it "is prepared to work with Congress" on a new pathway. No such pathway has been enacted.

State law for hemp cannabinoids varies and needs counsel state by state. The practical point: a CBD strip labeled as a dietary supplement contradicts FDA's stated position, and a CBD strip marketed sublingually adds the ingestion problem on top. CBD is excluded from StripWorks' U.S. supplement program until federal law or regulation changes and counsel approves the specific project.

THC and delta-8

THC sits in the same FDA answer as CBD: excluded from the supplement definition under 201(ff)(3)(B), and barred from conventional food under 301(ll). Cannabis and THC also fall under federal and state controlled-substance and cannabis-licensing law, which these sources do not cover.

Delta-8 gets its own note because it is sold as a hemp product. FDA's consumer update states that "delta-8 THC products have not been evaluated or approved by the FDA for safe use in any context," reports 104 adverse event reports between December 2020 and February 2022 and 2,362 poison control exposures (41 percent pediatric), and warns that "some manufacturers may use potentially unsafe household chemicals to make delta-8 THC."

An oral strip is small, flavored, and fast-dissolving, which is to say child-appealing by design. Every concern FDA raised about delta-8 products applies with more force to a strip. StripWorks does not manufacture THC, delta-8, or other intoxicating cannabinoid strips in any form; brands in state-legal cannabis markets need a licensed manufacturer inside that state's system.

Kratom and 7-OH

FDA states that kratom "is not appropriate for use as a dietary supplement," is "an unsafe food additive," and "is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food." There are no FDA-approved drugs containing kratom or its alkaloids, kratom has been on import alert, and FDA's ingredient directory lists it under safety communications and NDI concerns.

7-hydroxymitragynine (7-OH) is a minor kratom alkaloid that, in FDA's description, "comprises less than 2% of the total alkaloid content in natural kratom leaves" but "demonstrates substantially greater mu-opioid receptor potency" than the main alkaloid. On July 29, 2025, FDA recommended "a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH) products under the Controlled Substances Act," noted it had "issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots" in June, and stated that "there are no FDA-approved 7-OH drugs, 7-OH is not lawful in dietary supplements and 7-OH cannot be lawfully added to conventional foods." FDA's 7-OH page, updated July 13, 2026, reports that on July 1, 2026 the DEA began a temporary scheduling process for 7-OH above a proposed threshold and three synthetic derivatives.

FDA has said its target is concentrated 7-OH rather than natural leaf, but its position on kratom as a supplement ingredient is unchanged. StripWorks does not manufacture kratom, kratom extract, or 7-OH strips.

Nicotine

Nicotine has no supplement pathway. DSHEA excludes tobacco from the definition and nicotine is not a dietary ingredient. Two FDA frameworks apply, and the marketing picks which. Per FDA's tobacco products page, "nicotine pouches, nicotine gels, and dissolvable tobacco products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by FDA through the Center for Drug Evaluation and Research (CDER) as drugs." A nicotine strip sold for quitting is a nicotine replacement therapy drug under the OTC monograph or an approved application.

A nicotine strip not marketed for cessation is a tobacco product. Since a law that "went into effect on April 14, 2022," FDA's authority covers "tobacco products containing nicotine from any source, including synthetic nicotine." A non-tobacco nicotine product "can only be legally marketed in the United States if it received premarket authorization from FDA"; without it "a product is in violation of the FD&C Act and is subject to FDA enforcement." The route is a premarket tobacco product application, which "must provide scientific data that demonstrates a product is appropriate for the protection of public health." FDA authorized 20 nicotine pouch products that way on January 16, 2025, and said authorization "does not mean these tobacco products are safe, nor are they 'FDA approved.'"

A dissolvable nicotine film needs a PMTA marketing order or a drug application before sale. Neither is a supplement project. StripWorks does not manufacture nicotine strips.

Prescription peptides and GLP-1s

Semaglutide, tirzepatide, and the other GLP-1 receptor agonists are approved prescription drugs. Under the drug-exclusion clause they cannot be dietary ingredients, and under 21 U.S.C. 321(g) any product marketed for weight loss is a drug by intended use whatever is in it. The only non-approved source is compounding, and FDA is direct about that: "compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed." Compounding is for patients whose "medical need cannot be met by an FDA-approved drug," done by licensed pharmacies or outsourcing facilities under sections 503A and 503B, not by contract manufacturers. FDA has also flagged compounded products using salt forms such as semaglutide sodium or acetate that "are different active ingredients than are used in the approved drugs."

The wider peptide category is enforcement-heavy. FDA's list of bulk drug substances nominated for compounding that "may present significant safety risks" (category 2) includes GHRP-2, GHRP-6, ipamorelin acetate, kisspeptin-10, and ibutamoren mesylate; BPC-157, AOD-9604, CJC-1295, thymosin beta-4 fragment, and Melanotan II were nominated and withdrawn by their nominators. None are dietary ingredients. Putting one in an oral film is marketing an unapproved drug.

The peptide oral film feasibility guide describes what a legitimate peptide-adjacent supplement looks like: food-derived peptide fractions with a dietary ingredient history. StripWorks does not quote semaglutide, tirzepatide, or research peptides as supplement strips and does not manufacture compounded drugs.

NMN, NAD+, and the status nuance

Beta-nicotinamide mononucleotide is the clearest case of a status that moved. In November 2022 FDA took the position that NMN was excluded from the supplement definition under the drug-exclusion clause, having been authorized for investigation as a new drug before, in the agency's then view, it was marketed as a supplement. Trade reporting indicates that in letters dated September 29, 2025 FDA reversed that position after concluding NMN had been marketed as a supplement first. What can be verified on fda.gov today is that NMN notifications are being filed and reviewed: the published NDIN list shows an NMN notification submitted November 17, 2025 with a response dated January 28, 2026, and a reduced NMN calcium salt notification with a response dated April 17, 2026.

So NMN is treated as a new dietary ingredient. A notification must be on file, or a supplier's notification must cover the same ingredient and conditions of use, and a no-objection response is not an approval. StripWorks scopes NMN to a development target of up to 150 mg per strip. A provisional feasibility view can come first, but acceptance requires the supplier's NDIN reference and documentation and a current U.S. or destination-market review, and the 2022 objection is treated as superseded.

NAD+ and its other precursors have their own records. Niacinamide is a long-standing vitamin form; nicotinamide riboside appears on the NDIN list (a citrate form notified July 2025, response September 2025); NAD+ as a direct dietary ingredient has a thinner record. Each is a supplier-documentation question, not a category prohibition. StripWorks scopes NMN, NR, and NAD+ strips as supplements where NDI status and supplier files are in order, with no anti-aging disease claims.

Melatonin, caffeine, and fat-soluble vitamins: notes on dose

Melatonin is a permitted dietary ingredient and one of the most common strip actives. Two notes. Route first: FDA's February 5, 2019 warning letter on a sublingual melatonin product stated that a product intended to enter the body through the mucosal tissues is not intended for ingestion and so is not a dietary supplement. A melatonin strip labeled for sublingual absorption has the same problem; one that dissolves in the mouth and is swallowed does not. Dose second: none of the FDA sources here set a maximum, but a small flavored strip is a child-appealing format and melatonin's status differs across export markets. StripWorks' standard U.S. adult ceiling without further review is 5 mg per strip; there is no child-targeted melatonin program; export projects are adult-only by default and get destination-market review; and child-resistant secondary packaging is available where law, channel, or customer specification requires it.

Caffeine is permitted and easy to over-specify in a strip. FDA's consumer guidance says that for most adults "the FDA has cited 400 milligrams a day" as "an amount not generally associated with negative effects," about two to three 12-ounce cups of coffee. A strip is a repeatable dose that is easy to take several of. StripWorks' standard ceiling is 80 mg per strip, and multi-strip servings are reviewed against that daily figure.

Vitamins A and D are permitted with established Daily Values: 900 mcg RAE for vitamin A and 20 mcg (800 IU) for vitamin D for adults and children four and older. Both are fat-soluble, so high multiples per strip raise label, safety, and substantiation questions even though the regulations cited set no supplement ceiling. StripWorks' standard ceilings before additional safety review are 2,000 IU vitamin D3 and 900 mcg RAE vitamin A per strip; higher doses are considered only after the intended population, daily serving, and applicable upper-intake limits are reviewed. None of these three is a restricted active. They are here because they are so often requested at doses or with claims that create avoidable problems.

What StripWorks will and will not quote

StripWorks quotes oral dissolving strips as dietary supplements for ingestion, with dietary ingredients whose status and supplier documentation can be verified, for brands that will label and market them as supplements.

We do not quote, as supplement strips, any active FDA has stated is excluded from the supplement definition or not lawful in supplements (CBD and other cannabinoids, THC, kratom, 7-OH), any active that is a drug or tobacco product by definition (nicotine, prescription peptides, GLP-1 agonists, research peptides), or any product marketed for sublingual or buccal absorption or with disease claims. Those are drug, tobacco, or state-cannabis products and need a manufacturer operating under that pathway. Nothing on this page is a claim about StripWorks' facility certifications or registrations; scope and documentation are confirmed in project records.

If an active is borderline, send the details, not the category: exact ingredient identity and source, supplier documentation, NDI status if any, dose per strip, intended use and claims, and market. That is what a feasibility review needs. Statuses reflect FDA sources as of September 2026 and will be updated as they change.

Common questions

Primary sources

• 21 U.S.C. 321 — definitions of 'drug' (g) and 'dietary supplement' (ff) (Office of the Law Revision Counsel)
• Public Law 103-417, Dietary Supplement Health and Education Act of 1994 (GovInfo, Statutes at Large)
• 21 CFR 190.6 — Requirement for premarket notification (GovInfo)
• FDA — New Dietary Ingredient (NDI) Notification Process
• FDA — Submitted 75-Day Premarket Notifications for New Dietary Ingredients
• FDA — Information on Select Dietary Supplement Ingredients and Other Substances
• FDA — FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD): Questions and Answers
• FDA — FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol (January 26, 2023)
• FDA — 5 Things to Know about Delta-8 Tetrahydrocannabinol (May 4, 2022)
• FDA — FDA and Kratom
• FDA — FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers (July 29, 2025)
• FDA — Hiding in Plain Sight: 7-OH Products (updated July 13, 2026)
• FDA — Other Tobacco Products (nicotine pouches, dissolvables)
• FDA — Regulation and Enforcement of Non-Tobacco Nicotine (NTN) Products
• FDA — Premarket Tobacco Product Applications
• FDA — FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products (January 16, 2025)
• FDA — FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (updated September 1, 2026)
• FDA — Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
• FDA Warning Letter — DK Vitamins (sublingual melatonin), February 5, 2019
• FDA — Daily Value on the Nutrition and Supplement Facts Labels
• FDA — Questions and Answers on Dietary Supplements
• FDA — Spilling the Beans: How Much Caffeine is Too Much? (updated August 28, 2024)