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November 2019
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While there are different types of claims, i.e., health claims, disease claims, structure-function claims, some claims may cause a product to be subject to heightened regulation. For example, if a product is otherwise classified as food, but its labeling contains disease claims, the FDA will classify this product as a drug. On the other hand, certain claims, called structure-function claims, may be made about dietary supplement products and, if done correctly, will not cause these products to be subject to heightened regulation. At Shehadeh Giannamore, PLLC, we provide a range of FDA attorneys, FDA lawyers, and FDA consultant services to help businesses become FDA compliant. Call us now at (305) 507-9843, or you can also visit our website for more details.
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FDA has particular requirements for the labels of the products it regulates, including the supplement facts panels of dietary supplements. In particular, the FDA requires certain statements to be made on the Principal Display Panel (PDP) of many FDA-regulated products, such as the Net Quantity of Contents, Statement of Identity, etc. However, it must be noted that the label requirements differ based on product classification. If you would like to know more about our reviews of supplement facts panels or how an FDA regulatory attorney can help you ensure FDA compliance, please feel free to contact Shehadeh Giannamore, PLLC at (305) 507-9843. You can also visit us online for more details.
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Under FALCPA and accompanying FDA regulations, major allergens must be declared in the labeling of all food products (including dietary supplements) sold in the United States. If the significant allergens are not appropriately stated, companies face the possibility of detention/refusal, warning letters, and (because allergens invoke serious health risks to consumers) even recalls. Accordingly, it is essential for marketers to stay up-to-date with current labeling regulations to avoid costly mistakes. For more information about food regulations or our services, call Shehadeh Giannamore, PLLC at (305) 507-9843. You can also visit our website for more details about our FDA consultant services.
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