J&J Consulting Group- FDA Regulatory Compliance
- 1101 California Ave Suite 100 Corona CA 92881
- Info@jjccgroup.org
- (800) 999-7781
FDA Regulatory Services for Dietary Supplements
Providing regulatory guidance and quality assurance to ensure dietary ingredients meet safety standards and global market requirements successfully.
Call for Appoinment
800 999 7781
Assurance
Built for brands, manufacturers and online sellers
FDA does not approve dietary supplements before sale. That puts the full burden on you: safe ingredients, a compliant label, truthful claims and a facility that meets Part 111. Our founder held quality and regulatory roles at NBTY, one of the largest U.S. supplement makers. We help you get each piece right the first time.
Our Expertise Covers
Expert Regulatory Consulting Tailored to Your Needs
We offer a comprehensive suite of regulatory services designed to navigate the complex and ever-evolving compliance landscape, from initial strategy development and submission preparation to post-approval lifecycle management. Whether you’re a startup launching your first product or an established organization expanding into new territories, our experts deliver the deep technical knowledge and strategic insight needed to move your projects forward with confidence.
Manufacturing
21 CFR Part 111
Specifications, identity testing, master and batch records, quality control, reserve samples
Labeling
21 CFR Part 101
Supplement Facts panel, statement of identity, net quantity, allergens, domestic contact
Claims
FD&C Act 403(r)(6); § 101.93
Structure/function claims need the FDA disclaimer and notice to FDA within 30 days of marketing
New ingredients
FD&C Act 413; § 190.6
NDI notification at least 75 days before an NDI enters interstate commerce
- Dietary supplement brands
- Nutraceutical companies
- Functional food manufacturers
- Contract manufacturers
- Amazon and eCommerce sellers
- Health & wellness startups
Who we work with
Trusted by Industry Leaders Across Supplements
Supplement brands, contract manufacturers, private-label distributors, Amazon and eCommerce sellers, and startups launching a first product.
Our Advantages
Why choose J&JCC Group for dietary supplement compliance
JJCC Group provides industry-specific regulatory consulting for dietary supplements and nutraceuticals. We deliver tailored compliance strategies, hands-on implementation, and trusted guidance to help brands succeed.
Trusted by industry leaders
We help emerging and established brands achieve market leadership through regulatory guidance and audit readiness.
New Product Launch Support
JJCC Group helps manufacturers and brand names companies in ingredient assessment, GRAS classification and NDI submissions, health claim and readiness checks for market.
Manufacturing & Quality Compliance
We perform cGMP quality audits, create QMS, and provide employee training to ensure consistent compliance to regulation 21 CFR 111, 21 CFR 117, and 21CFR 101.
Global Market Expansion Guidance
We provide expert guidance for Health Canada, EU/EFSA, APAC compliance, including TGA, KFDA, and other international regulations.
Part 111 or Part 117?
Comprehensive Regulatory Services for Dietary Supplement
Finished supplements are made under Part 111. Ingredient makers usually fall under Part 117. A facility that follows Part 111 is exempt from Part 117’s preventive-control and supply-chain subparts (§ 117.5(e)), but still needs Part 117 cGMP for any conventional food it makes.
Best Compliance with 5 Star
99% Happy Clients
Testimonial
What our clients say about JJCC
Leading supplement and nutraceutical companies trust JJCC for reliable regulatory guidance and successful product approvals.
JJCC expertly managed our dietary supplement compliance, ensuring FDA approval, labeling, GMP, and regulatory requirements smoothly.
Faqs
Frequently asked questions
JJCC Group provides clear guidance on dietary supplement compliance, FDA regulations, labeling, manufacturing, and international market requirements.
Our experts assist with ingredient assessments, GRAS and NDI notifications, claim substantiation, GMP audits, SOP development, and global market entry strategies.
Does FDA approve dietary supplements?
No. FDA does not approve supplements or their labels before sale. The company is responsible for safety, labeling and claims, and FDA acts after products reach the market.
What is 21 CFR Part 111?
dietary supplements. It covers personnel, facilities, equipment, specifications, records, quality control and complaints.
What is 21 CFR Part 117, and does it apply to supplements?
Part 117 covers cGMP and preventive controls for human food, including many supplement ingredients. Facilities that comply with Part 111 are exempt from its preventive-control and supply-chain subparts.
Who must comply with Part 111?
Anyone who manufactures, packages, labels or holds dietary supplements, including contract manufacturers and brand owners that release product.
Is a brand owner responsible if a contract manufacturer makes the product?
Yes. FDA holds the brand owner responsible for its product. You must qualify your manufacturer and review its records.
What testing does Part 111 require?
How long must supplement records be kept?
Keep Part 111 records for 1 year past the shelf-life date, or 2 years past distribution of the last batch if there is no shelf-life date.
What is a structure/function claim?
t describes how a nutrient affects the body's structure or function, such as "supports joint health." It needs the FDA disclaimer and a notice to FDA within 30 days of marketing.
What claims turn a supplement into a drug?
Claims to diagnose, treat, cure, mitigate or prevent disease. "Lowers blood pressure" is a disease claim; "supports healthy circulation" may be a structure/function claim.Claims to diagnose, treat, cure, mitigate or prevent disease. "Lowers blood pressure" is a disease claim; "supports healthy circulation" may be a structure/function claim.
