FDA Regulatory Framework for Supplements
Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994, which creates specific requirements for product labeling, manufacturing, and claims. While supplements don't require FDA pre-approval like drugs, they must comply with regulations that affect payment processing relationships.
Structure/function claims are permitted for supplements, but disease claims are not. Saying a product 'supports immune health' is acceptable; saying it 'prevents colds' crosses into drug claims. This distinction matters for payment processing because disease claims can trigger regulatory action that affects processor relationships.
Current Good Manufacturing Practices apply to supplement manufacturing. Facilities must meet quality standards for production, testing, and record-keeping. Processors may inquire about manufacturing compliance as part of underwriting, particularly for private label or self-manufactured products.
Adverse event reporting requirements obligate supplement companies to report serious problems to FDA. Compliance with reporting requirements is part of the regulatory posture that sophisticated processors evaluate.
Processing Implications of FDA Compliance
Underwriting for supplement processors often includes regulatory compliance questions. Processors want assurance that products meet FDA requirements for labeling and claims. Evidence of compliance supports application approval and ongoing account stability.
FDA warning letters create processing problems. When FDA issues public warning letters about labeling, claims, or manufacturing violations, processors take notice. Warning letters can trigger account reviews and may result in termination even if violations are subsequently addressed.
Product liability concerns connect to FDA compliance. Non-compliant products face higher liability exposure, which translates to processing risk. Processors consider product liability as part of overall risk assessment.
Documentation of compliance supports processing relationships. GMP certifications, third-party testing, and label review documentation all demonstrate the compliance discipline processors prefer.
How Goodlane Group Supports FDA Compliance
We help supplement companies understand how FDA compliance affects processing relationships. While we're not regulatory attorneys, we understand what processors look for and how compliance posture affects underwriting and account stability.
Our processor recommendations consider compliance documentation requirements. Working with processors who understand supplement regulations smooths underwriting and reduces compliance-related account concerns.
We advise on compliance documentation practices that satisfy processor requirements while supporting regulatory obligations. Organized compliance records serve multiple purposes.
For merchants facing compliance questions from processors, we help address concerns and demonstrate corrective actions that preserve account relationships.