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As the holder of a dietary supplement brand, it is your responsibility to notify the FDA when making structure/function claims about your product. This requirement is part of the Dietary Supplement Health and Education Act of 1994 (DSHEA). The FDA does not pre-approve these claims but mandates that they be substantiated and accompanied by the necessary disclaimer.
What Are Structure/Function Claims?
Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the human body. These claims include:
Structure/Function Claims: A statement about how a nutrient or ingredient affects the body’s structure or function.
General Well-Being Claims: A statement about the general health or well-being benefits of a nutrient or ingredient.
Classical Nutrient Deficiency Disease Claims: A claim related to a nutrient deficiency disease, with information about the prevalence of the disease in the U.S.
These claims must be supported by evidence, such as scientific studies, that demonstrate the claim is truthful and not misleading. The evidence is not submitted to the FDA, but must be kept on file in case of an audit.
FDA Disclaimer
Each claim you make must include the following FDA-required disclaimer:
This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
The 30-Day Notification Requirement
Under DSHEA, you must notify the FDA within 30 days of first marketing the product with a structure/function claim. This notification is a procedural requirement, not an approval, and it is your responsibility to ensure the claim is truthful and not misleading.
Failure to notify the FDA on time could result in the following consequences:
Misbranding: The product may be considered misbranded under the FDCA (Federal Food, Drug, and Cosmetic Act).
Regulatory Action: The FDA may issue warning letters or inspection citations.
Product Seizure: In severe cases, your product may be seized, or importation may be refused.
False Advertising Liability: You may be held liable for false advertising.
FDA Review and Public Disclosure
While the FDA does not pre-approve structure/function claims, it may take enforcement action if the claim:
Implies disease treatment or prevention.
Lacks the proper disclaimer or the disclaimer is incorrectly formatted.
Is not substantiated or is misleading.
Additionally, the FDA publicly posts all submitted claims, so noncompliance can be flagged by competitors, consumers, or other stakeholders.
Steps To Submit The Notification
Step 1: Prepare the Notification Letter
Prepare the notification letter, which should include the following:
Your company name and address.
The exact text of the structure/function claim(s).
The name of the dietary supplement for which the claim is being made.
A statement that the claim is being made in accordance with 21 U.S.C. §343(r)(6).
Certification that the company has substantiation showing the claim is truthful and not misleading.
You can use the free-form letter format if submitting via post, or you can refer to a step-by-step guide for submitting via the FDA’s ePortal.
Step 2: Send the Form
You have two submission options:
By Mail: Send the notification via post to:
Food and Drug Administration
Center for Food Safety and Applied Nutrition (CFSAN)
Office of Dietary Supplement Programs (HFS-810)
5001 Campus Drive
College Park, MD 20740Electronically via ePortal: Submit your notification through the FDA’s Centralized Online Submission Module (COSM). You can find detailed instructions for submitting via ePortal here.
By following these steps, you ensure your dietary supplement claims are in compliance with FDA regulations, minimizing the risk of legal and regulatory consequences.
Read more information on the FDA website.
While Supliful strives to provide accurate and up-to-date information on the latest regulations and laws in the US, we cannot oversee all aspects. Therefore, please note that this article may not be exhaustive. Depending on your specific jurisdiction, you may have additional obligations and responsibilities. Always consult with a legal advisor to ensure full compliance with all applicable laws and regulations in your jurisdiction.