DSHEA, GRAS, MoCRA, organic, Non-GMO Project Verified, FDA Prior Notice, customs documentation, and category-specific compliance — handled by credentialed regulatory science on staff, not outsourced to consultants.
Structure/function claims development, ingredient documentation, label review, and FDA notification preparation. New Dietary Ingredient (NDI) notifications when required. Credentialed regulatory science on staff.
GRAS self-affirmation and GRAS notification dossier preparation. FDA food contact substance compliance. Allergen control programs and HACCP plan integration.
MoCRA registration, facility listing, adverse event reporting, and product safety substantiation. 21 CFR cosmetic GMP compliance anchored by 22 continuous years of cosmetics quality leadership on staff.
USDA Organic certification support, Non-GMO Project Verified support, kosher and halal certification coordination. Documented organic ingredient chain-of-custody.
All three TTB licenses held on premises — Spirits, Malt, and Wine. Formula approval (TTB Form 5100.51), COLA submissions, federal excise tax compliance, and state alcohol registration coordination.
FDA Prior Notice for imports, USDA APHIS documentation, country-specific labeling for 100+ international markets, customs HTS classification, and freight forwarding documentation.
Most brands experience regulatory as friction: the consultant who writes the dossier doesn't talk to the formulator who built the product, and neither talks to the QA team that runs the facility. By the time problems surface — an ingredient that doesn't have organic certification documentation, a structure/function claim that won't survive FDA scrutiny, a foreign label that fails customs — the launch is already weeks behind schedule. McClary integrates these functions under one operations team so problems surface during formulation rather than at the import dock.
Regulatory leadership includes a Certified Food Scientist with 35+ years of R&D and regulatory science tenure across Fortune 500 food, flavor, and ingredient enterprises, plus 14 years as a Research Fellow at a category-defining beverage and ingredients company. Personal care regulatory is anchored by 22 continuous years of cosmetics GMP and 21 CFR experience on staff — relevant for both the long-standing FDA cosmetics framework and the new MoCRA requirements. The team handles DSHEA notifications, GRAS dossier preparation, organic certification chain-of-custody, Non-GMO Project Verified documentation, kosher and halal coordination, and category-specific compliance programs.
On the logistics side, the McClary network holds all three TTB licenses on premises — Spirits, Malt, and Wine — a credential held by very few contract manufacturers. For international shipments, the team manages FDA Prior Notice, USDA APHIS documentation, country-specific labeling requirements, customs HTS classification, and freight forwarder coordination across 100+ international markets. Domestic logistics include EDI integration with major retail channels and full cold-chain documentation for temperature-controlled categories.
Whether you have a formula ready or just an idea — our team responds within 24 hours to discuss fit, format, and the regulatory path.