Dietary Supplements

The U.S. Food and Drug Administration (FDA) plays a pivotal role in overseeing dietary supplements to ensure they are safe, wholesome, and accurately labeled before reaching consumers. Unlike conventional foods and drugs, dietary supplements do not require FDA pre-market approval. However, manufacturers are obligated to ensure that their products are safe, produced under Current Good Manufacturing Practices (CGMP), and that any health claims are truthful and not misleading.

The FDA actively monitors and inspects supplement manufacturing facilities, evaluates the labeling of these products, and takes enforcement actions against products that pose health risks to consumers. In addition to federal requirements, products offered in the stream of commerce may also be subject to additional requirements by specific U.S. states.

At Asebey Life Science Law, we provide specialized legal services to help clients comply with the intricate regulatory landscape governing dietary supplements. We have expertise in advising on compliance with CGMPs, crucial for maintaining the identity, purity, strength, and composition of dietary supplements. We also assist clients in responding to FDA enforcement actions, conducting facility audits, and ensuring that all product claims are substantiated, accurate, and compliant with regulations.

Our aim is to empower our clients to successfully market their products while adhering to the highest standards of safety and compliance, thereby fostering public health and consumer confidence.

Services Provided

  • General compliance with the Dietary Supplement Health and Education Act (DSHEA)
  • Label, website, and advertising reviews for FDA compliance
  • 30-day notification letters to FDA for structure / function claims
  • FDA Warning Letters and 483 responses to FDA
  • Regulatory opinions regarding novel dietary supplement products
  • New Dietary Ingredient Notifications (NDIN) preparation and submission
  • Management of national recalls of dietary supplement products
  • General compliance with the Food Safety Modernization Act (FSMA), Foreign Supplier Verification Program (FSVP), Hazard Analysis and Risk-based Preventive Controls (HARP-C)
  • California Prop 65 defense
  • Management of importation of dietary ingredients and dietary supplements

Representative Matters

  • Assisted a Danish company in creating a dossier in support of a New Dietary Ingredient Notification (NDIN) for submission to FDA
  • Provided regulatory opinion regarding use of hemp-derived cannabinoids in dietary supplements
  • Guided a US company in the development of dietary supplement beverages containing novel botanicals
  • Provided guidance to a dietary supplement company seeking to generate data for claim substantiation under §403(r) of the Food, Drug and Cosmetics Act (FD&CA)
  • Performed label, advertising, and social media review for Kava and Kratom-containing beverages
  • Filed 30-day notice with FDA for client’s structure / function claims
  • Managed national recall of dietary supplements and interfaced with FDA
  • Responded to FDA Warning letters and 483s on behalf of numerous dietary supplement clients

Schedule a consultation and ensure your dietary supplements meet all regulatory standards.

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