Know What the US FDA Does Not Approve

The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.

Company’s website or in commercial promoting a product or treatment some marketers may say their products are “FDA approved.” But how can you know sure what the U.S. FDA has approved?

1. The FDA doesn’t approve facilities

The FDA doesn’t approve medical product companies, health care providers, including physician offices, or laboratories.

2. The FDA doesn’t approve compounded drugs

Compounding is generally a practice in which a pharmacist or doctor combines ingredients to create medications that meet the needs of individual patients, including those who are allergic to ingredients in FDA-approved medicines or who cannot swallow an FDA-approved pill.

3. The FDA doesn’t approve tobacco products

There’s no such thing as a safe tobacco product, so the FDA’s safe and effective standard for evaluating medical products does not apply to tobacco products.

4. The FDA does not approve cosmetics

The ingredients (except certain colors) and labeling of cosmetics, i.e perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations do not require FDA approval.

5. The FDA doesn’t approve medical foods

A medical food is formulated to be consumed or administered enterally and intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.

6. The FDA doesn’t approve infant formula

The FDA doesn’t approve infant formulas before they can be marketed.

7. The FDA doesn’t approve dietary supplements

The FDA is not authorized to approve dietary supplements for safety and effectiveness.

8. The FDA doesn’t approve the food label, including the Nutrition Facts label

The FDA doesn’t approve individual food labels before food products can be marketed. But FDA regulations require specific labeling elements, including nutrition information, to appear on most foods, including dietary supplements.

9. The FDA doesn’t approve structure-function claims on dietary supplements and other foods

Structure-function claims describe the role of a food or food component (such as a nutrient) that is intended to affect the structure or function of the human body.

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