Supplements Compliance
Dietary supplement compliance support for US manufacturers and brands, from cGMP programs to FDA labeling review.
Dietary Supplement Compliance and FDA Support
The dietary supplement industry faces complex and evolving regulatory requirements. Our team provides specialized expertise to ensure your products meet all FDA regulations and state-specific requirements.
From facility registration to cGMP compliance and labeling review, we provide comprehensive support to help supplement manufacturers maintain full regulatory compliance.
Under the Dietary Supplement Health and Education Act of 1994, manufacturers and distributors are responsible for evaluating the safety and labeling of their products before marketing. FDA explains that it can take action against an adulterated or misbranded supplement after it reaches the market, so compliance has to be built in from the start.
Our label reviews follow the FDA Dietary Supplement Labeling Guide, and we can pair them with the dietary supplements version of our federal policy pack. To talk through your products, contact our team.
Supplement Compliance Services
Dietary supplement compliance support for manufacturers, brands and distributors
cGMP Compliance Programs
Implementation and maintenance of current Good Manufacturing Practices for dietary supplements.
FDA-Compliant Labeling
Review and development of compliant product labels meeting all FDA requirements. We check the statement of identity, nutrition labeling, ingredient list and any claims on the label.
Adverse Event Reporting
Setup and management of the adverse event reporting systems FDA requires, a core part of dietary supplement compliance.
California Prop 65 Compliance
Ensure compliance with California's Proposition 65 requirements.
Facility Registration & Inspections
FDA facility registration and preparation for regulatory inspections.
Product Development Support
Regulatory guidance during new product development to ensure compliance. If a formula uses a new dietary ingredient, we flag the FDA premarket notification process early.
Strengthen Your Supplement Compliance
Contact us today to discuss your dietary supplement compliance needs and regulatory challenges.
