Supplements
A Balanced Approach
Supplement Support
Gardner Law advises and supports companies with their dietary supplements and medical foods. We assist clients in navigating complex regulations to ensure their products are marketed legally and effectively. Our varied experience allows us to represent our clients’ best interests while navigating the FDA. With years of dedicated practice, Gardner Law provides the essential support your business needs u to achieve compliance and market success.
Representative Matters Include:
- New Dietary Ingredient (NDI) submissions
- Supplement Facts and labeling reviews
- 21 CFR 101.93 compliance, structure-function claims, CFSAN notices
- Consent decree negotiation with FDA and DOJ
- Reviewing website and mobile apps, terms of use
- Privacy and cybersecurity policies and procedures
- Privacy and security incidents
- Privacy officer and data protection officer services
- Privacy training for organizations, including case coverage and complaint handling
- FDA quality requirements
- Privacy and cybersecurity audits
- Recalls, corrections, and removals
- Litigation and enforcement actions
- Product liability strategy and counseling
- Advertising and promotional review
- Due diligence review for FDA-regulated companies