Approved by the FDA or Not? Part 4


Infant Formula is not Approved by the FDA

Infant formulas do not require FDA approval before going to market. That said, formula manufacturers are subject to regulatory oversight from the agency.

Federal nutrient requirements need to be adhered to when the formula is being made. Manufacturers looking to bring a new product to market must first register with the FDA and provide notification of intent.

Manufacturers facilities are inspected by the FDA on a yearly basis, during which time samples of the infant formula are collected for testing. If these tests show that the formula presents any type of health risk, the manufacturer will be asked to conduct a recall.

Dietary Supplements are Not Approved by the FDA

While new drugs need to be approved by the FDA before going to market, the same is not the case with dietary supplements. The exception here is if the product includes a new dietary ingredient, which would be one that has not been marketed in the U.S. prior to October 15, 1994. Manufacturers using such an ingredient must notify the FDA 75 days prior to marketing.

When the manufacturer submits the notification information to the FDA, they must deliver a conclusion that shows that their dietary supplement is safe. If a health concern arises after a new product hits the market, the FDA will use research and event monitoring to better evaluate the safety of the dietary supplement.

Food Labels, Which Include the Nutrition Facts Panel, are Not Approved by the FDA

Individual food labels are not approved by the FDA before food products hit the market. That said, food manufacturers are required to show nutrition information on foods, as well as dietary supplements. When manufacturers make claims about their products, they cannot include false or misleading information.

The Nutrition Facts panel on a food label must show the serving size of the food, as well as the nutrient content. With dietary supplements, that information is usually shown on the Supplement Facts panel.

The FDA Does Not Approve Structure-Function Claims Found with Foods and Dietary Supplements

Foods or food components that are made to affect the structure or function of the human body will have structure-function claims that describe their role. “Calcium building stronger bones” is an example of such a claim.

Manufacturers of dietary supplements who create products with structure-function claims on their labels are required to submit a notification to the FDA. This notification needs to be submitted to the agency no later than 30 days after the product has gone to market. Items that need to be included in the notification are things such as the text of the claim, the notifier’s name and address, and other relevant information. The structure-function claims made on dietary supplement come with a disclaimer which makes it clear that the product has not been granted approval by the FDA, and that it is not intended as a treatment, cure, or diagnosis of any disease.

Conventional food manufacturers do not need to notify the FDA, nor do they need to carry a disclaimer, about structure-function claims.


 

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