Food, drugs, cosmetics and medical devices are highly regulated by the Food and Drug Administration (FDA). The FDA regulates both dietary supplement products and dietary ingredients under a different set of regulations than those covering “conventional” foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed. The dietary supplement manufacturer is faced with numerous regulatory issues that could prove costly or disastrous to the dietary supplement manufacturer if not advised properly. A dietary supplement lawyer can advise as to:
- Compliance with FDA/DSHEA Regulations
- The Legal Status of Dietary Ingredients
- Marketing and Advertising Claims
- Current Good Manufacturing Practices (cGMPs)
- Preparing and Filing New Dietary Ingredient Notifications (NDI)
- Label Content and Label Claims
- Substantiation Requirements
- Adverse Event Reporting
- Seizures and Import Detentions
- FDA Inspections
- FDA Warning Letters
- Federal Trade Commission (FTC) Inquires and Challenges
A dietary supplement lawyer will have the industry-specific experience to advise dietary supplement manufacturers and nutraceutical companies how to maintain compliance with a variety of statutory and regulatory requirements.
The law firm of Charles C. Weller A.P.C. & Associates provides cutting-edge advice and cost-effective legal solutions for clients in the nutritional supplement industry. For more information on a Dietary Supplement Lawyer, please see https://cweller.com/Practice-Areas/Dietary-Supplement-Lawyer.html.