- Calcium builds strong bones
- Copper is essential for red blood cell formation
- Vitamin C helps the body absorb iron
- Folic acid is essential for cell growth and division
When it comes to food, dietary supplement, and cosmetic labeling, structure-function claims are statements about the effects that a product has on the body’s structure or function. This guide provides an in-depth look into FDA regulations surrounding these claims and how to ensure compliance. The FDA has strict regulations on these claims, and it’s important to understand them to avoid legal issues.
Gain the upper hand in preparing structure-function claim notifications for a successful pre-market notification to the FDA
According to 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, it is mandatory for any dietary supplement (that is marketed with at least one structure-function claim) to notify FDA within 30 days after the dietary supplement is first marketed in US.
When wording structure/function claims, it is important to use language that accurately reflects the scientific evidence supporting the claim. Avoid using language that implies the product can treat or cure a disease, as this is not allowed by the FDA. Instead, focus on the specific function or benefit the product provides. Additionally, make sure to include the required disclaimer stating that the product is not intended to diagnose, treat, cure, or prevent any disease. It may be helpful to consult with a legal expert or regulatory consultant to ensure that your claims comply with FDA regulations.
We help you prepare the structure-function claim notification, develop your product labelling, ensure your product labels comply with FDA regulations. Note that only electronic submissions receive confirmation from FDA of receipt.
To avoid making false or misleading claims, it is important to have a thorough understanding of the scientific evidence supporting your product’s structure/function claims. Make sure to use language that accurately reflects the evidence and avoid making claims that the product can treat or cure a disease. It is also important to include the required disclaimer stating that the product is not intended to diagnose, treat, cure, or prevent any disease. Consulting with a legal expert or regulatory consultant can also help ensure that your claims comply with FDA regulations.
Violating FDA regulations on structure/function claims can result in serious consequences for businesses in the health and wellness industry. The FDA can take enforcement action against companies that make false or misleading claims, including issuing warning letters, seizing products, and pursuing legal action. In addition to legal consequences, violating FDA regulations can also damage a company’s reputation and lead to loss of consumer trust. It is important to ensure that all claims made about a product are supported by scientific evidence and comply with FDA regulations to avoid these consequences.
The dietary supplement regulations are very technical. Staying compliant with FDA regulations or submitting a 30-day notification with federal law is complex. Consequently, marketers of dietary supplement products look for assistance from a team of experienced and talented FDA consultants.
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