Regulatory & logistics, integrated. — McClary Industries
How We Work · 03

Regulatory
& logistics, integrated.

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.

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How We Work

Regulatory as a discipline, not a checklist.

Most contract manufacturers treat regulatory as a documentation handoff: you handle the paperwork, we make the product. McClary integrates regulatory science directly into formulation, manufacturing, and fulfillment — led by a Certified Food Scientist with Research Fellow-level industry tenure and senior R&D leadership across Fortune 500 food, flavor, and ingredient enterprises. For dietary supplements, functional foods, personal care, and TTB-licensed beverages, the regulatory work happens in-house alongside the product.
Regulatory Disciplines

Regulatory disciplines

DSHEA & dietary supplements

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 & food safety

GRAS self-affirmation and GRAS notification dossier preparation. FDA food contact substance compliance. Allergen control programs and HACCP plan integration.

MoCRA & personal care

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.

Organic & Non-GMO certification

USDA Organic certification support, Non-GMO Project Verified support, kosher and halal certification coordination. Documented organic ingredient chain-of-custody.

TTB & alcohol licensing

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.

International compliance

FDA Prior Notice for imports, USDA APHIS documentation, country-specific labeling for 100+ international markets, customs HTS classification, and freight forwarding documentation.

By the Numbers

Credentialed regulatory science, on staff.

CFS
Certified Food Scientist on staff
3
TTB licenses on premises
100+
International markets served
4
Layers of quality organization
How It Works

Regulatory integrated, not outsourced.

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.

Regulatory Disciplines at a Glance

DSHEA Notifications
structure/function claims · NDI notifications · label review
GRAS Support
self-affirmation · FDA notification dossiers · food contact
MoCRA Registration
facility listing · safety substantiation · adverse event
Organic & Non-GMO
USDA Organic · Non-GMO Project · kosher · halal
TTB Licensing
all three licenses on premises · formula approval · COLA
International Compliance
FDA Prior Notice · APHIS · country labeling · customs
Related Capabilities

Capabilities to know about.

Formulation & R&D

Career-track formulation chemists and a Certified Food Scientist — regulatory built into formulation from day one.

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Fulfillment

International distribution to 100+ countries with full customs and regulatory documentation.

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Certifications

Site-level certifications: GFSI-aligned food safety, USDA Organic, NSF, kosher, halal, and category-specific GMP.

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Get Started

Tell us what you're building.

Whether you have a formula ready or just an idea — our team responds within 24 hours to discuss fit, format, and the regulatory path.

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