Short answer: Every supplement maker must be registered with FDA (registration is free) and follow FDA's supplement manufacturing rules in 21 CFR Part 111; cosmetic facilities must register under MoCRA and renew every two years. NSF, USP, USDA Organic, kosher and halal are voluntary and depend on your formula, your claims and the retailers you sell to. [1] [4] [6]
What is a manufacturing certification?
Definition: A manufacturing certification is an independent organization's written confirmation, after a review or audit, that a facility or product meets a named standard. It is not the same as a legal requirement: FDA registration and good manufacturing practice (GMP) rules are the law, while marks like NSF, USP, organic, kosher and halal are earned voluntarily.
Brands often ask a manufacturer "are you certified?" as one question. It is really three: what the law requires, what an outside auditor has checked, and what you want to print on your label.
Key stats
- $0: FDA charges no fee to register a food or supplement facility (21 CFR 1.231(c)), and FDA does not issue registration certificates. (FDA) [1]
- Under 20 ppm: the gluten limit for any FDA-regulated food labeled "gluten-free," including dietary supplements. (FDA) [15]
- 95% and 70%: the minimum organic content for a product labeled "organic" and for one labeled "made with organic ingredients" under USDA rules. (USDA AMS) [12]
- Every 2 years: how often cosmetic facility registrations under MoCRA must be renewed. (Foley & Lardner, 2026) [6]
- 14,299 and 992,907: active cosmetic facility registrations and product listings reported as of January 6, 2026. (Foley & Lardner, 2026) [6]
- December 2024: the MoCRA deadline for FDA to propose cosmetic GMP rules, which was missed; final rules are not expected in 2026. (EcoMundo, April 2026) [7]
Which certifications are actually required by law?
Dietary supplements. The facility must be registered with FDA as a food facility. There is no fee, and FDA states it "does not issue a certificate of registration," nor does it recognize registration certificates sold by private businesses. [1] Manufacturing must follow the supplement GMP rule, 21 CFR Part 111, which requires specifications "for the identity, purity, strength, and composition" of each finished batch and limits on contamination, plus tests or examinations to confirm those specifications are met. [2] [3] [4]
Cosmetics (skincare, hair care, body care). Under the Modernization of Cosmetics Regulation Act (MoCRA), manufacturers and processors must register each facility with FDA, renew every two years and list each product. [6] FDA has not yet issued cosmetic GMP rules. [7] In the meantime, a facility can follow, and be certified against, the international guideline ISO 22716, which covers "the production, control, storage and shipment of cosmetic products." [8] See our guide to who the responsible person is under MoCRA.
OTC drugs (for example, sunscreen and acne products). Under 21 CFR 330.1, an OTC monograph product must be made under drug GMPs (21 CFR Parts 210 and 211) in a registered establishment, and the product must be listed with FDA. This is a step up from cosmetic or supplement production. [5]
What do NSF, USP and other GMP certifications prove?
FDA registration comes with no certificate, so retailers and buyers may ask for an independent audit as proof of good manufacturing practice. [1]
- NSF GMP (NSF/ANSI 455-2): a standard for auditing supplement facilities that measures compliance with 21 CFR 111 and adds retailer requirements. [10]
- USP Verified Mark: a product-level mark. USP says a verified product contains the listed ingredients in the declared potency and amounts, does not contain harmful levels of specified contaminants, breaks down and releases in the body within a specified time, and was made according to FDA GMPs. [11]
- ISO 22716 certification: an audit by a certification body (Kiwa is one) against the cosmetics GMP guideline, useful while U.S. cosmetic GMP rules are pending. [9]
Have a product in mind? Ask us directly.
How do organic, kosher, halal and gluten-free claims work?
USDA Organic. Products made with agricultural ingredients, including cosmetics and personal care products, may be eligible for certification under the National Organic Program. Growers, handlers and the final product manufacturer must all be certified by a USDA-accredited certifying agent. "Organic" requires at least 95% organic ingredients; "made with organic ingredients" requires at least 70% and cannot carry the USDA seal. [12]
Kosher. Certified by private kosher agencies. At OU Kosher, for example, the steps include an application, a review of every ingredient, a plant visit by a rabbinic field representative, a contract, and ongoing visits at intervals. [13]
Halal. Also issued by private certifiers. The halal certifier IFANCA, for example, certified hundreds of a U.S. supplier's food and supplement ingredients after inspecting its manufacturing facilities. [14]
Gluten-free. A legal definition applies: a supplement labeled "gluten-free" must contain less than 20 parts per million of gluten. [15]
Cruelty-free and vegan. FDA says "there are no legal definitions" for "cruelty free" or "not tested on animals." Ask which standard or certifier backs the claim, and apply the same question to "vegan." [16]
Certification comparison table
| Certification or requirement | Required or voluntary | Who checks it | What it shows | Applies to |
|---|---|---|---|---|
| FDA facility registration | Required | FDA (no fee, no certificate) | Facility is on file with FDA (not an approval) | Supplements, cosmetics, OTC |
| Supplement GMP (21 CFR 111) | Required | FDA inspections | Specs and testing for identity, purity, strength, composition | Supplements |
| Drug GMP (21 CFR 210/211) | Required | FDA inspections | Drug-grade production controls | OTC drugs |
| MoCRA registration and listing | Required | FDA | Facility registered, product listed | Cosmetics |
| NSF/ANSI 455-2 GMP | Voluntary | NSF auditors | Facility audited against 21 CFR 111 plus retailer requirements | Supplements |
| USP Verified Mark | Voluntary | USP | Product meets label potency, contaminant and dissolution checks | Supplements |
| ISO 22716 | Voluntary | Third-party auditors | Cosmetic GMP guideline followed | Cosmetics |
| USDA Organic | Voluntary, but rules apply once claimed | USDA-accredited certifying agents | 95% / 70% organic content rules met | Products with agricultural ingredients |
| Kosher / Halal | Voluntary | Private religious certifiers (e.g., OU, IFANCA) | Ingredients and plant reviewed and inspected | Foods, supplements, some cosmetics |
| Gluten-free | Voluntary claim with a legal limit | FDA rule (less than 20 ppm) | Gluten below the limit | Supplements and foods |
| Cruelty-free / Vegan | Voluntary | Varies (no legal definition for cruelty-free) | Depends on the standard used | Mostly cosmetics |
The 3-Layer Certification Check: how should a brand vet a manufacturer?
- 3 · THE CLAIM (what you print)
USDA Organic (95% / 70%) · Kosher · Halal · Gluten-free (under 20 ppm) · Vegan / Cruelty-free
- 2 · THE AUDIT (voluntary proof)
NSF/ANSI 455-2 · USP Verified · ISO 22716
- 1 · THE LAW (required)
FDA registration · GMP rule (21 CFR 111 supplements / 210-211 OTC) · MoCRA registration + listing (cosmetics)
- 1.Layer 1, the law: confirm the facility's FDA registration (and MoCRA registration for cosmetics, or drug establishment registration for OTC) and ask how it meets the GMP rule for your category.
- 2.Layer 2, the audit: ask for current audit certificates (NSF, ISO 22716 or similar) if your retailers require them, and check the scope covers your product format.
- 3.Layer 3, the claim: for every word you plan to print (organic, kosher, halal, gluten-free, vegan, cruelty-free), confirm which certifier backs it and that it covers your exact formula and facility.
Printable checklist: questions to ask before you sign
Download the fillable checklist (PDF)
Questions to ask before you sign
- Which facility will make my product, and is it registered with FDA for this category?
- How does the facility meet 21 CFR 111 (supplements) or 21 CFR 210/211 (OTC)? Does it follow ISO 22716 for cosmetics?
- Which third-party audits are current, and when do they expire?
- Does the audit scope include my format (capsules, gummies, lotions, liquids)?
- Can you provide organic, kosher or halal certificates that name this facility and my formula?
- Who certifies the organic content, and does the formula reach 95% or 70%?
- If I claim gluten-free, how is the under-20-ppm limit verified?
- What standard backs any vegan or cruelty-free claim?
How does Product Management Group handle certifications?
PMG manufactures through FDA-registered, GMP-compliant partner facilities, with MoCRA-compliant operations for cosmetics. Across that network, USDA Organic, Kosher, Halal, vegan formulations, Cruelty-Free, Gluten-Free and allergen-controlled manufacturing are available. Certifications are held by PMG's partner manufacturing facilities and are confirmed per product and per facility before production. See Certifications & Compliance and Nutraceuticals & Supplements. [17] Private label starts at 1,000 units and custom formulas at 5,000 units per SKU, and a private label launch typically takes about 60 to 90 days from contract to first production run. For more questions to ask, read How to Choose a Private Label Manufacturing Partner, or start a project.
Frequently asked questions
Is “FDA approved” the same as “FDA registered”?
No. Registration is a filing with FDA, not an approval or endorsement. FDA does not issue registration certificates, and it does not recognize registration certificates issued by private businesses. [1]
Is NSF certification required to sell supplements?
No. The legal requirement is FDA's GMP rule, 21 CFR Part 111. NSF/ANSI 455-2 is a voluntary audit against that rule plus retailer requirements; some retailers ask for it. [4][10]
Do cosmetics need GMP certification?
Not yet. MoCRA requires facility registration and product listing, but FDA has not issued cosmetic GMP rules. A facility can be certified against the international guideline ISO 22716 in the meantime. [6][7][8]
Can a skincare product be USDA organic?
Yes, if it is made with agricultural ingredients and meets National Organic Program standards, with every handler and the final manufacturer certified by a USDA-accredited agent. [12]
What does a gluten-free supplement claim require?
The product must contain less than 20 parts per million of gluten under FDA's gluten-free rule, which covers dietary supplements. [15]
Glossary
- cGMP: current good manufacturing practice, the FDA rules for how products are made and controlled.
- 21 CFR Part 111: FDA's GMP rule for dietary supplements.
- 21 CFR Parts 210/211: FDA's GMP rules for drugs, including OTC products.
- MoCRA: the Modernization of Cosmetics Regulation Act, the law that added facility registration and product listing for cosmetics.
- ISO 22716: the international GMP guideline for cosmetics.
- NSF/ANSI 455-2: an audit standard for supplement GMPs.
- USP Verified Mark: USP's product-level quality mark for supplements.
- Accredited certifying agent: an organization USDA authorizes to certify organic operations.
Have a product in mind? Ask us directly.
What Has to Be on a Private Label Supplement Label? Supplement Facts, Claims, Disclaimer and Allergens
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Read the article →Who Is the Responsible Person Under MoCRA When You Private Label a Cosmetic?
Under MoCRA, the company named on a private label cosmetic's label is the responsible person. See who registers, lists and reports adverse events.
Read the article →Is Your Massage Oil or Muscle Rub a Cosmetic or an OTC Drug?
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Read the article →Can You Private Label Hotel Amenities? Body Wash, Shampoo and Lotion for Boutique Hotels and Spas
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Read the article →What Is a Pilot Batch, and Can Your First Production Run Be Under 1,000 Units?
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Read the article →Can You Private Label Essential Oils and Aromatherapy Kits for Amazon?
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Read the article →Can You Make Sugar-Free Pectin Gummies with Allulose?
How the gel changes without sugar, allulose vs sugar alcohols vs monk fruit and stevia, what a sugar-free label needs, and realistic minimums.
Read the article →How to Choose a Private Label Manufacturing Partner
10 questions to ask before you sign, plus a free evaluation checklist.
Read the article →MOQ and Manufacturing Volume: What Actually Matters
Why minimums exist, what they cost below volume, and how to plan a first run you can sell through.
Read the article →How Much Does It Cost to Manufacture Supplements?
A phase-by-phase breakdown of R&D, ingredients, production, packaging, and compliance costs.
Read the article →What Does It Take to Manufacture an OTC Acne Product?
Allowed actives and strengths, Drug Facts labeling, NDCs and registration, and realistic OTC minimums and timelines.
Read the article →Sources and references
- 1.FDA, Questions Regarding Whether Food Facilities Are Required to Pay Registration Fees and Private Businesses Claiming or Suggesting an Affiliation with FDA https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/questions-regarding-whether-food-facilities-are-required-pay-registration-fees-and-private
- 2.21 CFR 111.70, What specifications must you establish? (Cornell LII) https://www.law.cornell.edu/cfr/text/21/111.70
- 3.21 CFR 111.75, What must you do to determine whether specifications are met? (Cornell LII) https://www.law.cornell.edu/cfr/text/21/111.75
- 4.FDA, Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements
- 5.21 CFR 330.1, General conditions for general recognition as safe, effective and not misbranded (eCFR) https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-330/subpart-A/section-330.1
- 6.Foley & Lardner, How MoCRA Is Reshaping FDA Oversight of Cosmetics in 2026 (March 2026) https://www.foley.com/insights/publications/2026/03/how-mocra-is-reshaping-fda-oversight-of-cosmetics-in-2026/
- 7.EcoMundo, MoCRA Update 2026: What Cosmetic Companies Should Expect (April 2026) https://www.ecomundo.eu/en/blog/mocra-update-2026
- 8.ISO 22716:2007, Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices https://www.iso.org/standard/36437.html
- 9.Kiwa, ISO 22716 Cosmetics GMP certification https://www.kiwa.com/en/services/certification/iso-22716-cosmetics-gmp-guidelines-on-good-manufacturing-practices/
- 10.NSF/ANSI 455-2, Good Manufacturing Practices for Dietary Supplements (ANSI Webstore) https://webstore.ansi.org/standards/nsf/nsfansi4552024
- 11.USP, USP Verified Mark https://www.usp.org/verification-services/verified-mark
- 12.USDA AMS, Cosmetics, Body Care Products, and Personal Care Products (fact sheet) https://www.ams.usda.gov/sites/default/files/media/OrganicCosmeticsFactSheet.pdf
- 13.OU Kosher, Steps for Kosher Certification https://oukosher.org/get-certified-application/
- 14.BI Nutraceuticals receives Halal certification from IFANCA (2007) https://www.nutraceuticalsworld.com/breaking-news/bi-nutraceuticals/
- 15.FDA, Gluten and Food Labeling https://www.fda.gov/food/nutrition-education-resources-materials/gluten-and-food-labeling
- 16.FDA, Cruelty Free/Not Tested on Animals https://www.fda.gov/cosmetics/cosmetics-labeling-claims/cruelty-freenot-tested-animals
- 17.Product Management Group, Certifications & Compliance and homepage https://productmgmtgroup.com/services/certifications-and-compliance
Fact-checked: 43 claims verified against sources; 7 adjusted.
Manufacturer Certification Checklist
A fillable 1-page checklist with the 3-Layer Certification Check and all 8 questions to ask before you sign.
PDF · 1 page
About Product Management Group
PMG is a full-service private label manufacturing partner for skincare, nutraceuticals, supplements, personal care, and wellness brands. We handle everything from R&D and formulation through manufacturing, packaging, regulatory compliance, and fulfillment, working with FDA-registered, GMP-compliant partner facilities in Florida, North Carolina, Texas, Minnesota, and Arizona. We work with everyone from first-time founders to established retail brands, with minimums starting at 1,000 units.