USDA Organic supplement manufacturer
HBM holds USDA Organic certification at its Tampa Bay facilities, covering both gummy and liquid production.
HBM is a USDA Organic supplement manufacturer operating from Tampa Bay, FL. Certification is held under 7 CFR 205, the federal standard administered by USDA's National Organic Program. The label requires at least 95% organic content by weight, excluding water and salt. HBM's certification is renewed annually through a USDA-accredited certifier. Coverage spans both the St. Petersburg gummy facility and the liquid facility, so a brand can run a USDA Organic gummy and a USDA Organic tincture under one quality system. USDA Organic is one of 8 certifications HBM holds, alongside FDA Registration, NSF, Non-GMO Project Verified, Ecocert, Health Canada, Florida DBPR, and Made in USA.
What USDA Organic means for a supplement SKU
USDA Organic is a federal standard under 7 CFR 205. It governs how ingredients are grown, handled, and processed. Three label tiers exist. “100% Organic” requires every ingredient to be certified organic. “USDA Organic” requires at least 95% organic content by weight, excluding water and salt. “Made with organic ingredients” requires 70% to 94% organic content and cannot carry the USDA seal. For a supplement, the math is tighter than it sounds. Excipients, flow agents, natural colors, and natural flavors all count toward the non-organic 5%. A formula that looked organic on paper can fall short once the full ingredient deck is built. HBM’s R&D process flags this at formula review, before bench samples run.
How the certification works at HBM
Annual audit by a USDA-accredited certifier. The audit covers ingredient sourcing documentation and the organic system plan. It also covers segregation procedures between organic and conventional runs, sanitation between runs, and traceability from raw material to finished unit. Segregation is the operational load. HBM’s St. Petersburg gummy facility runs both organic and conventional SKUs through four continuous depositing stations rated at 300KG/hour each (two run at a time). Changeover between an organic run and a conventional run follows a documented clean-down, with verification logged in the batch record. The same logic applies to the liquid facility’s 2,500L of mixing capacity.
USDA Organic vs. Non-GMO Project Verified
These two certifications often get conflated. They are not the same thing. USDA Organic prohibits GMO inputs as part of the broader organic standard. Non-GMO Project Verified is a standalone third-party verification with a <0.9% GMO threshold per ingredient. HBM holds both. A SKU can be USDA Organic only, Non-GMO Project Verified only, or both. The Non-GMO Project mark is more recognized on US retail shelves. USDA Organic carries more weight in natural channels and on Amazon's organic filters. R&D scopes which marks make sense per project at the discovery call.
Practical formulation constraints
Several common supplement inputs are difficult or impossible to source as certified organic. Synthetic vitamins (most B vitamins, vitamin D3, vitamin K2) are not eligible for organic certification because they are synthesized. They can be included under the National List of allowed non-organic ingredients, but they count toward the 5% non-organic cap. Natural colors, natural flavors, and pectin can be sourced as certified organic, but the supply chain is thinner and pricing runs higher. HBM’s sourcing team confirms organic availability before the formal preliminary estimate. Lead times on organic raw materials can add 1-2 weeks compared to conventional inputs.
Documentation a buyer receives
Per-batch documentation includes the COA, the batch record, and the organic compliance attestation tying the lot to the organic system plan. The COA covers identity, potency, and contaminant testing. The batch record traces every input lot back to its certified-organic source documentation. On audit request, HBM provides the full chain from raw material certificate to finished unit lot code.
Frequently asked questions
Is HBM a certified USDA Organic supplement manufacturer?
Yes. HBM holds USDA Organic certification under 7 CFR 205. Coverage spans both the St. Petersburg gummy facility and the Tampa Bay liquid facility. Certification is renewed annually through a USDA-accredited certifier. USDA Organic is one of 8 certifications HBM maintains. The others are FDA Registration, NSF, Non-GMO Project Verified, Ecocert, Health Canada, Florida DBPR, and Made in USA.
Can HBM make a USDA Organic gummy?
Yes. HBM runs USDA Organic gummies on the same continuous depositing lines used for conventional production. Changeover between organic and conventional runs follows a documented clean-down with batch-record verification. Standard MOQ is 300,000 gummies, or 600,000 at smaller mold sizes. Lead times on organic raw materials can add 1-2 weeks versus conventional inputs. R&D confirms organic ingredient availability before the formal preliminary estimate.
What's the difference between USDA Organic and Non-GMO Project Verified?
USDA Organic is a federal standard under 7 CFR 205 covering how ingredients are grown and processed. It prohibits GMO inputs as part of the broader organic rule. Non-GMO Project Verified is a standalone third-party verification with a <0.9% GMO threshold per ingredient. HBM holds both. A buyer can carry one mark, the other, or both. R&D scopes the right combination at the discovery call.
Can synthetic vitamins be in a USDA Organic supplement?
Synthetic vitamins are allowed under the National List of permitted non-organic ingredients. They count toward the 5% non-organic cap allowed under the USDA Organic label. Most B vitamins, vitamin D3, and vitamin K2 are synthesized and fall under this category. HBM's R&D team flags non-organic inputs at formula review. The check happens before bench samples run, so the label tier is locked early.
What documentation does HBM provide for a USDA Organic batch?
Per-batch documentation includes the COA, the batch record, and the organic compliance attestation. The COA covers identity, potency, and contaminant testing. The batch record traces every input lot back to its certified-organic source. On audit request, HBM provides the full chain from raw material certificate through finished unit lot code. Records are retained per cGMP for the product shelf life plus one year.
Related pages
Scoping a USDA Organic SKU?
HBM's R&D team confirms organic ingredient availability and label tier before bench samples. Run an organic gummy program or organic liquid program under one quality system.
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