FDA Dietary Supplements Guidance

“This statement has not been evaluated by the Food and Drug Administration.” When you see this disclaimer on the label of a dietary supplement, you might think the FDA does not regulate what you can or cannot say about functional foods or dietary supplements. You are not alone in this feeling. Many companies, including large and well-established ones, have misinterpreted the disclaimer. The FDA does regulate functional foods (like fortified food and drinks) and dietary supplements/natural remedy products distributed in the United States. In fact, the FDA has recently stepped up its enforcement efforts against companies for safety and labeling violations, which included issuance of warning letters, product seizures, and civil and even criminal penalties. It’s more important than ever to be sure that your products comply with applicable regulations.

Our firm provides a broad range of international legal and regulatory services related to the production and marketing of dietary supplements.

Labeling Review:FDA regulations require that certain information appear on food and dietary supplement labels, such as statement of identity, net quantity of contents, and ingredient information. The information must also be formatted in accordance with the regulations. By law, companies may make three types of claims on their products: health claims,structure/function claims, and nutrient content claims. Different requirements generally apply to each type of claim. Unless specifically allowed by regulation, a company is prohibited from making labeling claims that imply its food products diagnose, cure, mitigate or prevent disease.

Our firm conducts label and ingredient reviews for all functional foods and dietary supplements in accordance with FDA regulations. This includes review of structure/function claim, health claims, and nutrient content claims, as well as the formatting of the labeling.

The firm also can help you file a 30-Day Structure/Function Claim Notification with the FDA for your dietary supplements.

Advertising Review: Our firm provides advertising counseling for your functional foods and dietary supplements to ensure conformance with regards to third-party testimonials and websites, social media, claim substantiation (amount of scientific support) and various other Federal Trade Commission (FTC) regulations.

Facility Registration and Prior Import Notice: The FDA requires facilities that manufacture, process, pack or store foods and dietary supplements marketed in the U.S. file registrations with FDA. Under theBioterrorism Act, foreign food and dietary supplement manufacturers must also register with the FDA and provide prior notice of import before their products arrive in the U.S. We can assist you with registration and  filing Prior Import Notices and will work closely with your Customs broker to ensure compliance with the Bioterrorism Act and Prior Import Notice requirements.

Adverse Event Reporting & Record Keeping: Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a dietary supplement company whose name appears on the product label must report to the FDA certain adverse events associated with the product and maintain reports of adverse events. Our firm helps clients develop process and standard operating procedures (SOPs) for identifying and reporting adverse events, train monitoring staff on the process, and conduct audits to assess compliance.

Export Certificates: Struggling to determine whether you need a n Export Certificate to  Foreign Governments, Certificate of Exportability, or Certificate of a Pharmaceutical Product? Not sure whether to use Form 3613a or 3613b? We can help you apply for the right export certificate for your device. Our firm offers the experience to make the process simple and straightforward, eliminating confusion on what forms and attachments to include. Whether your already selling the product in the US or only looking to export we can help.

Import Alerts: If the FDA customs detained your product an immediate response is required to avoid listing on an Import Alerts. Import Alerts are publicly published notices of violations that also allow the FDA to detain every shipment that enters the country. If you’ve already received an Import Alert, such as Import Alert  89-08, we can help petition the Agency for removal. Our firm offers experience working with clients from South Korea to Canada and Europe to petition the FDA for removal from an Import Alert.

Warning Letter & Border Detention Assistance: If you received a warning letter from the FDA, or if your products were detained at the border, you may be able to ask the FDA to allow you to “fix” a deficiency so that you wouldn’t have to destroy the products or ship them out of the country. However, you only have a short period of time to make the request, and you need to act fast. We can help you respond and take appropriate actions so you can get back to business. Contact the firm as soon as possible for a free initial consultation.

There are many other components to our practice, including:

  • Interpretation of scope of relevant legislation and regulations;
  • Analysis of regulatory status and assistance in obtaining approval of ingredients and packaging material components;
  • Compliance advice on labeling and point-of-purchase material, including health-related claims;
  • Advise on product certificates, traceability issues, and product recalls;
  • Advise on advertising claims and promotional materials, including electronic media;
  • Food additive approvals in the EU, US, and China;
  • Manufacturing practices compliance; and
  • Import and export issues.

Our firm represent clients in negotiations on matters related to food and dietary supplements with various regulatory agencies including the Food and Drug Administration, the US Department of Agriculture, the Environmental Protection Agency, and the Federal Trade Commission.