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 made as dietary supplements at all, or that can only be made under a drug or tobacco pathway. Answering each one privately wastes the buyer's time and ours, and answering vaguely invites a project that has to be cancelled at scoping. This page states, active by active, what FDA has said, what that means for a supplement oral strip, and where StripWorks draws its line.

The framing is deliberately factual. FDA's positions are cited from fda.gov and from the statute and regulations; where a status is contested or has changed, the page says so and marks what should be confirmed. Nothing here is legal advice, and state law (which matters for hemp cannabinoids, kratom, and nicotine) is outside the FDA sources cited. A brand pursuing any of these actives should do so with regulatory counsel and, where a drug or tobacco pathway applies, with a manufacturer operating under that pathway.

StripWorks' position is simple: it does not quote drug-pathway or excluded actives as dietary supplement strips. That is a scope decision, not a judgment about an ingredient's merit or a prediction about future regulation; it keeps the company's supplement work, and its clients' products, on the right side of the definitions explained in the FDA regulation guide.

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), as 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 that is 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 dietary supplement or food before that approval or authorization. This is the race-to-market rule: whichever use came first controls. It is the basis of FDA's CBD position, it was the basis of a dispute over NMN, and it is why prescription peptides cannot be sold as supplements.

Two more filters apply. An ingredient that is not a vitamin, mineral, botanical, amino acid, or dietary substance is not a dietary ingredient at all, whatever the marketing says. And a dietary ingredient not marketed in the US before October 15, 1994 is a new dietary ingredient needing a 75-day premarket notification under 21 CFR 190.6. Each table row below is the result of running the active through those tests using FDA's own statements.

CBD and hemp cannabinoids

FDA's position on CBD is explicit. In its cannabis Q&A, the agency answers whether CBD can be sold as a dietary supplement with "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 states that it is prohibited under section 301(ll) to introduce into interstate commerce any food to which CBD or THC has been added. FDA's ingredient directory lists CBD under the category "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 the agency to allow CBD in supplements, and stating that it "is prepared to work with Congress" on a new pathway. As of this writing no such pathway has been enacted at the federal level.

State law for hemp-derived cannabinoids varies and is outside the FDA sources cited here; evaluate it with counsel state by state. The practical point is that a CBD strip labeled as a dietary supplement contradicts FDA's stated position, and a CBD strip marketed sublingually raises the ingestion problem on top of it. StripWorks does not quote CBD or other hemp cannabinoid strips as dietary supplements.

StripWorks' current rule: CBD is excluded from the standard U.S. dietary-supplement program unless and until federal law or regulation changes and regulatory counsel approves the specific project.

THC and delta-8

THC sits in the same FDA answer as CBD: the agency has concluded that THC products are excluded from the dietary supplement definition under 201(ff)(3)(B), and that THC cannot be added to conventional food under section 301(ll). Cannabis and THC are also subject to federal and state controlled-substance and cannabis-licensing law, which is outside the FDA sources on this page and must be evaluated with counsel.

Delta-8 THC deserves its own note because it is often marketed 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 exposure cases (41 percent involving pediatric patients), says products are "marketed in ways that put the public health at risk," and notes that "some manufacturers may use potentially unsafe household chemicals to make delta-8 THC" through chemical synthesis.

An oral strip is a form that appeals to children by design: small, flavored, and fast-dissolving. That makes the marketing and exposure concerns FDA raised for delta-8 products directly applicable. StripWorks does not manufacture THC, delta-8, or other intoxicating cannabinoid strips in any form. Brands operating in state-legal cannabis markets need a licensed manufacturer within that state system.

Kratom and 7-OH

FDA states that kratom "is not appropriate for use as a dietary supplement," that it is "an unsafe food additive," and that it "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 drug products containing kratom or its alkaloids. Kratom has been on an import alert, and FDA's ingredient directory lists it under safety communication and new dietary ingredient 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 primary alkaloid. On July 29, 2025, FDA announced it was recommending "a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH) products under the Controlled Substances Act," noted that in June it had "issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots," 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 announced the start of a temporary scheduling process for 7-OH above a proposed threshold and three synthetic derivatives.

FDA has said it is targeting concentrated 7-OH, not natural kratom 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 dietary supplement pathway; the DSHEA definition excludes tobacco, and nicotine is not a dietary ingredient. FDA regulates nicotine products under two frameworks, and the marketing decides 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 to help people quit would be a nicotine replacement therapy drug, subject to the OTC monograph or an approved application.

A nicotine strip not marketed for cessation is a tobacco product. Since a federal law that "went into effect on April 14, 2022," FDA's authority covers "tobacco products containing nicotine from any source, including synthetic nicotine." FDA states that non-tobacco nicotine products "can only be legally marketed in the United States if it received premarket authorization from FDA," and that 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 (PMTA), which "must provide scientific data that demonstrates a product is appropriate for the protection of public health." FDA authorized 20 nicotine pouch products through that pathway on January 16, 2025, and stated that authorization "does not mean these tobacco products are safe, nor are they 'FDA approved.'"

A dissolvable nicotine film would therefore need 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 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) a product marketed for weight loss is a drug by intended use regardless of ingredient. The only non-approved source is compounding, and FDA is direct about what that means: "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 noted that some compounded products use salt forms such as semaglutide sodium or acetate that "are different active ingredients than are used in the approved drugs."

The broader peptide category is enforcement-heavy. FDA maintains a list of bulk drug substances nominated for compounding that "may present significant safety risks" (category 2), which currently includes peptides such as GHRP-2, GHRP-6, ipamorelin acetate, kisspeptin-10, and ibutamoren mesylate; other well-known research peptides, including BPC-157, AOD-9604, CJC-1295, thymosin beta-4 fragment, and Melanotan II, were nominated for the compounding lists and withdrawn by their nominators. None of these are dietary ingredients, and marketing them in an oral film would be marketing an unapproved drug.

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

NMN, NAD+, and the status nuance

Beta-nicotinamide mononucleotide (NMN) is the clearest example of a status that has moved. In 2022 FDA took the position that NMN was excluded from the dietary supplement definition under the drug-exclusion clause, because it had 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 submitted and reviewed: FDA's published NDIN list shows an NMN notification submitted November 17, 2025 with an FDA response dated January 28, 2026, and a reduced NMN calcium salt notification with a response dated April 17, 2026.

The practical status is that 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. Before quoting an NMN strip, StripWorks asks for the supplier's NDIN reference and documentation; the brand should confirm coverage with regulatory counsel.

NAD+ and its other precursors have different records. Niacinamide is a long-standing vitamin form; nicotinamide riboside appears on FDA's NDIN list (a citrate form notified in July 2025 with a response in 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 documentation are in order, with no efficacy or anti-aging disease claims.

StripWorks will scope NMN projects to a development target of up to 150 mg per strip. A provisional feasibility and price can be quoted first; final acceptance requires supplier-specific regulatory documentation and a current U.S. or destination-market review, and FDA's November 2022 objection is treated as historical position superseded by its September 2025 response.

Melatonin and fat-soluble vitamins: notes on dose

Melatonin is a permitted dietary ingredient in the United States and one of the most common oral strip actives. Two notes apply. First, the route: 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; a strip that dissolves in the mouth and is swallowed does not. Second, dose: none of the FDA sources cited here set a maximum melatonin amount for supplements, but a small flavored strip is a child-appealing format, and melatonin's status differs in several export markets. StripWorks scopes melatonin strips as supplements for ingestion and asks brands to justify the per-strip amount.

Vitamins A and D are permitted dietary ingredients with established Daily Values: FDA lists 900 mcg RAE for vitamin A and 20 mcg for vitamin D for adults and children four years and older. Both are fat-soluble, so very high per-strip amounts (many multiples of the Daily Value) raise label, safety, and substantiation questions even though no supplement ceiling is set in the regulations cited here. A strip is a small, easily repeated dose, which matters for a fat-soluble vitamin. StripWorks reviews high multiples of the Daily Value with the brand before development.

Neither is a restricted active. They are here because they are often requested at doses or with claims that create avoidable problems, and the fix is usually a label and dose decision made early with regulatory counsel.

StripWorks' standard U.S. adult ceiling without escalation is 5 mg melatonin per strip; higher doses require a specific safety and regulatory review, and there is no standard child-targeted melatonin program. Certified child-resistant secondary packaging is available and required wherever law, channel or customer specification calls for it. Export projects receive destination-market review before acceptance and are adult-only by default; a U.S. melatonin supplement is not assumed to be sellable globally.

StripWorks' standard formulation 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.

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, made for brands that will label and market them as supplements. Within that scope, custom and private-label projects can include vitamins, minerals, botanicals, amino acids, and other dietary substances, subject to feasibility review for dose loading, taste, and packaging.

StripWorks does 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 pathway products, and they need a manufacturer operating under that pathway. StripWorks does not describe its own facility as holding any certification or registration on this page; scope and documentation are confirmed in project records.

If an active is borderline, bring the details rather than the category: exact ingredient identity and source, supplier documentation, NDI status if any, intended dose per strip, intended use and claims, and the market. That is what a feasibility review needs to give a clear answer. Statuses on this page 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