FDA Registration & Compliance for Food & Dietary Supplements
Lisa Capote is an FDA Lawyer helping businesses register their food & dietary products with the FDA and for all compliance matters related to the FDA
The FDA regulates all foods distributed in the United States and regulates foods for safety, contamination, and proper labeling. Capote Law Firm conducts label and ingredient reviews for all foods and dietary supplement in accordance with FDA regulations. We help clients with obtaining FDA approval for food additives.
The Dietary Supplement Health and Education Act of 1994 gives the FDA jurisdiction over these products, which are treated as foods. As a result:
- Dietary supplements manufacturers, storage facilities, and packers are subject to FDA regulations under FDA Food Facility Registration rules
- Manufacturers are responsible for maintaining compliance under the Food Canning Establishment and Scheduled Process Identification rules for liquid supplements
We provide regulatory compliance with the Nutrition Labeling and Education Act, including health claims, nutrient content claims, and label formatting, as well as advertising rules and regulations under FTC. Our staff will also consult on the use of new qualified health claims for conventional foods, ensuring compliance for medical foods and formulas, as well as packaging materials. Knowing in advance what to expect and how to prepare time and money, allowing you to focus on your business and provide valuable products to consumers.
Dietary supplements are allowed to have structure and function claims, but not health claims. We can help you transition your dietary supplement from concept to market in the smoothest way possible. We will also provide advertising guidance for your product to ensure conformance with regards to testimonials, disclaimers, amount of evidence to support certain claims and various other FTC regulations. We will also file your 30 Day Structure/Function Notification with FDA.
Certain information must appear on dietary supplement and food labels, like ingredients, net quantity of ingredients, and statements of identity. This information, however, must be properly formatted to be in line with regulations. Unless allowed under regulation, companies are forbidden from making claims on labels that a product can prevent, cure, mitigate, or diagnose a disease. We work with you to review all of your labels to ensure they comply with FDA standards and that you have filed the proper paperwork for your products in order to go to market.
Have you received an FDA Warning Letter? Have you been audited by FDA? Let Capote Law Firm advise you on the best course of action with each of these.