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"FDA approval" is a general term for product labels, particularly for products marketed on Internet sites. Are They Really FDA Approved? The FDA does not approve a product until it has verified its safety and effectiveness.

Most products do not require FDA approval to market in the United States. All that is required is an FDA registration. In addition, the FDA has not approved the production facility. You may search for search FDA approvals via

The FDA may conduct audits / inspections of GMP conformance. A successful FDA audit / inspection without non-compliance does not mean the company is FDA approved.

The grocery store must be registered with the FDA and indicate the product category. As soon as the registration is successful, the FDA will issue an 11 digit registration number.

Food labels must meet FDA label requirements. However, it is the responsibility of the manufacturer / distributor to ensure that the product label is fully compliant. The FDA does not review or approve food labels.

New food supplements, new nutritional ingredients, and some coloring additives are the exceptions above which require FDA approval on the market.

Dietary supplements do not require FDA approval, only new food ingredients require FDA approval. Facility registration, GMP, labeling and material compliance are requirements.

Most Class III devices require FDA approval for marketing in the United States. Class II medical devices require only FDA approval (510,000), which is not approval. Most Class I devices have only general controls. All medical device facilities require FDA registration and a device list.

OTC Monograph compliant drugs do not require FDA approval, other drugs require NDA or YOU approval. HPUS-compliant homeopathic medicines do not require FDA approval. FDA registration, NDC label codes, drug lists, and label compliance are general requirements for all drugs.

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