Under federal law, dietary supplements may make certain claims on product labeling. These claims, referred to as “structure-function claims”, may be made on product labels and in product labeling (consisting of websites and other marketing materials) provided that: (1) the claim includes a mandatory disclaimer, (2) such claims are truthful and not misleading, and (3) the firm has notified FDA within 30 days of marketing the product bearing the claim (30-day notification).
30-day Notification / DSHEA Notification
In accordance with federal law and FDA regulations, we can help you with not only developing your product labeling but also with the drafting and submission of a 30-day notification. Also known as a DSHEA notification, from the law in which these requirements were founded, the Dietary Supplement Health and Education Act (“DSHEA”), these submissions are required under federal law. More information about the regulatory requirements for dietary supplement claims may be found here.
As you can see, because the dietary supplement regulations are very technical many marketers of dietary supplement products turn to an experienced FDA consultant or FDA regulatory attorney to prepare and submit a 30-day notification and ensure compliance with federal law. DSHEA notifications are a key way of how we help our clients ensure that their product labels are fully compliant with FDA regulations. From development of FDA compliant labeling to submitting a 30-day notification, the hiring of a FDA regulatory attorney is designed to allow you to market and sell your products in compliance with federal law in the United States.
30-Day Notification for Dietary Supplements
At Shehadeh Giannamore, PLLC, a FDA regulatory attorney can help you to ensure compliance with FDA regulations by:
- Drafting and preparing your 30-day notification in accordance with FDA regulations and relevant guidance documents;
- Submitting your 30-day notification on your behalf and acting as your contact person with the FDA, and
- Handling any communications with respect to the 30-day notification after it has been submitted to the FDA.