FDA registered supplement manufacturer
Facility-level FDA registration for HBM's Tampa Bay, FL dietary supplement plants.
HBM is an FDA registered supplement manufacturer operating 3 facilities in Tampa Bay, FL. Facility registration is held under the Bioterrorism Act and FSMA. It is renewed every two years on the biennial cycle. FDA registration is one of HBM's 8 certifications. The other 7 are NSF, Non-GMO Project Verified, USDA Organic, Ecocert, Health Canada, Florida DBPR, and Made in USA. FDA does not approve dietary supplement products. FDA registers the facility that makes them. HBM owns the registration directly. Most US contract manufacturers route gummy production to a partner facility whose registration the brand never sees.
Buyers ask about FDA registration on the first call. The question usually means one of two things. Either they want confirmation that HBM is on the FDA’s facility roster, or they want to know whether their finished SKU will be FDA-approved. The first answer is yes. The second answer is no, and not because of HBM. FDA does not approve dietary supplements. This page explains what HBM’s registration covers, what it does not cover, and how it stacks with the other 7 certifications.
What FDA registration means for a supplement manufacturer
FDA registration is a facility-level filing required under the Bioterrorism Act of 2002 and reinforced under FSMA. Every food facility selling into US commerce must register. Dietary supplement plants fall under the food facility category. HBM’s Tampa Bay, FL sites are registered directly under the HBM legal entity. The registration is renewed on the biennial schedule in even-numbered years. FDA can inspect a registered facility announced or unannounced. Inspection scope covers 21 CFR Part 111 (cGMP for dietary supplements): batch records, identity testing, complaint handling, recall readiness, and facility cleanliness.
What FDA registration does not mean
FDA does not approve dietary supplements. There is no product-level FDA stamp for a vitamin C gummy or a liposomal mineral shot. Brands that claim “FDA-approved” on a supplement label are out of compliance with DSHEA. What FDA does is register the facility, inspect it against cGMP, and enforce against false claims. The distinction matters when a buyer writes label copy. HBM can confirm facility registration on the COA package and in the batch record chain. HBM cannot confirm product approval, because product approval does not exist in this category.
How HBM's registration is structured
Registration is held by Health and Beauty Manufacturing, LLC. The St. Petersburg gummy facility and the liquid facility are covered. Two buildings of 30,000 sq ft each plus the 3,000 sq ft R&D lab are inside the registered footprint. 100% of the gummy facility is temperature-controlled, which matters for cGMP environmental controls. The DUNS number on file is 118669232. Buyers conducting their own supplier verification can pull HBM directly from the FDA Food Facility Registration database using the legal entity name.
How registration interacts with the other 7 certifications
FDA registration is the regulatory floor. It establishes that HBM is on the federal roster and subject to inspection. The other 7 certifications layer on top. NSF certifies against NSF/ANSI 173 for dietary supplements. The full [quality certifications](/quality/) stack is third-party verified annually. Non-GMO Project Verified covers ingredient sourcing at the <0.9% threshold. USDA Organic covers the 7 CFR 205 standard at ≥95% organic content. Ecocert covers European-market organic and natural standards. Health Canada Site License authorizes shipment of NHPs into Canada. Florida DBPR is the state-level food establishment license. [Made in USA](/quality/made-in-usa/) is the FTC designation for "all or virtually all" US-made product. Each cert is held under the same HBM legal entity. None are sub-contracted.
What buyers receive on every batch
Every batch ships with a COA showing identity, potency, and contaminant test results. The batch record is retained per cGMP, which is the shelf life of the product plus one year minimum. Lot codes on packaging tie back to the batch record. That chain is the basis for [recall readiness](/quality/recall-readiness/). Buyers can request batch records directly under NDA. HBM’s [audit batch records](/quality/audit-batch-records/) page covers the document set in detail.
Frequently asked questions
Is HBM an FDA registered supplement manufacturer?
Yes. HBM holds facility-level FDA registration for its Tampa Bay, FL plants. The registration is held directly by Health and Beauty Manufacturing, LLC. It covers the St. Petersburg gummy facility and the liquid facility. Renewal is biennial in even-numbered years per the FSMA schedule. FDA registration is one of HBM's 8 certifications. Buyers can verify it in the FDA Food Facility Registration database using the legal entity name.
Does FDA approve HBM's supplement products?
No. FDA does not approve dietary supplement products. This is true for every supplement on the US market, not just HBM's. DSHEA, the 1994 law that governs the category, does not include a pre-market approval step. What FDA does is register the facility and inspect it against 21 CFR Part 111. HBM's registration and cGMP compliance cover the facility. Brand-level claims remain the brand's responsibility under FDA and FTC enforcement.
How often is HBM's FDA registration renewed?
Every two years. FDA facility registration runs on a biennial cycle and is renewed in even-numbered years. HBM maintains the registration directly for its Tampa Bay, FL facilities. The renewal window runs from October 1 through December 31 of the renewal year. Missing the window suspends a facility's authority to ship product into US commerce. HBM tracks this on the quality calendar alongside the other 7 certifications.
Can buyers see proof of HBM's FDA registration?
Yes. HBM provides registration confirmation as part of the standard supplier qualification package. The document set includes the FDA registration confirmation, the cGMP audit summary, and the certifications register. Buyers can also pull HBM directly from the FDA Food Facility Registration database using "Health and Beauty Manufacturing, LLC" as the entity name. The DUNS number on file is 118669232. Full document review happens under NDA.
What's the difference between FDA registration and cGMP compliance?
FDA registration is the filing. cGMP compliance is the operating standard. Registration puts HBM on the federal roster and makes the facility inspectable. cGMP under 21 CFR Part 111 governs how the facility actually runs: batch records, identity testing, cleanliness, recall readiness. HBM holds both. Registration is renewed biennially. cGMP compliance is verified through third-party audits annually. The two work together: registration without cGMP compliance is a paperwork problem waiting for an inspection.
Related pages
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