Driven by a paradigm shift in lifestyle trends and health habits, the expanding market for nutraceuticals/dietary supplements is balanced by regulatory pressures and headline-grabbing intellectual property/trade secret, and litigation issues. Nutraceutical companies choose Nelson Hardiman as their business and litigation counsel because of our broad healthcare capabilities and our deep commitment to transformative innovation and entrepreneurial opportunities.
Our healthcare-centric attorneys understand the nuanced complexities of FDA and DSHEA regulatory requirements, advising nutraceutical manufacturers and resellers in California and nationwide. We counsel established and emerging nutraceutical businesses on strategic considerations, regulatory concerns, intellectual property and other legal issues, actuating our clients’ success in one of the fastest-growing healthcare sectors.
Our Work Includes:
- California Board of Pharmacy Defended a Board of Pharmacy action involving enteral nutrition (infant formula) products.
- FDA Compliance Utilized collaborative relationships with leading Washington, D.C. FDA boutique firms for federal lobbying and submission purposes.
- FDA Investigations Defended FDA investigations of a dietary supplement manufacturer.
- FDA Requirements Advised an online start-up medical food business on compliance with FDA requirements.
- Intellectual Property Engaged in trademark disputes involving nutraceuticals.
- Litigation Advance and defend nutraceutical clients before courts and federal and state enforcement officials, including the FDA and California Board of Pharmacy.
- Regulatory Compliance Audited a physician group to ensure compliance with federal and state requirements in nutraceuticals sales.