Fenton Nelson counsels manufacturers and resellers of nutraceuticals, which include dietary supplements, medical foods, and other non-pharmaceutical products that prevent and treat illness and disease. Nutraceuticals have been a growth area within health care industry, and many healthcare providers have incorporated nutraceutical products into their practices. Clients count on our experience in California and our ability to respond with speed and agility when issues arise.
Providers and regulators alike are often confused about the rules and regulatory requirements governing the manufacture and sale of nutraceuticals. There are distinct categories, including traditional drugs, traditional foods, supplements (which make no specific health claims), and medical foods (which are intended for the nutritional management of a specific disease under physician supervision). Legal and compliance issues that call for careful attention include labeling and advertising claims and content, mandatory and voluntary submissions, product manufacturing and packaging.
Fenton Nelson advances and defends our clients’ interests with respect to nutraceuticals before courts and federal and state enforcement officials (including the FDA and California Board of Pharmacy). We frequently advise clients in anticipating and addressing issues before they bloom into full fledged problems of regulatory enforcement or negative publicity. We assist clients in FDA and other audits and inspections. While we advise many physician organizations who are merely resellers of nutraceuticals, we are also regularly contacted by large national firms that are concerned by the geographic limits of their FDA counsel on the East Coast and outside of California. When necessary, we have collaborative relationships with leading Washington, D.C. FDA boutiques for federal lobbying and submission purposes.
Recent examples of representative matters we have handled include:
- advising an online start-up medical food business on compliance with FDA requirements
- defending a Board of Pharmacy action involving enteral nutrition (infant formula) products
- auditing a physician group to ensure compliance with federal and state requirements in nutraceuticals sales
- defending FDA investigations of dietary supplement manufacturer