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U.S. FDA Labeling Requirements

The U.S. Food and Drug Administration (FDA) defines “labeling” as “all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such an article.” This may include packaging, instructions, product inserts, websites, and other promotional materials.

Labeling mistakes result in more than 22% of all detentions in the United States. Registrar Corp can review your label for compliance with FDA regulations. In addition to a report of recommended changes, you will receive a print-ready graphic file of your revised label.

Food, Beverage, and Dietary Supplement Labeling and Ingredients Review

In 2016, FDA finalized significant changes to food, beverage, and supplement labeling, including updates to daily values, serving sizes, the Nutrition Facts chart, and more. Updates to daily values may affect what nutrient content claims, such as “high in fiber,” a label may bear. FDA’s compliance deadline for these rules is January 1, 2020 (or January 1, 2021 for manufacturers with less than 10 million in annual sales). Registrar Corp can update your food labeling for compliance with FDA’s new regulations.

Medical Device Labeling and Product Reviews

FDA may require your device’s label to include adequate instructions for use, servicing instructions, warnings statements, or information that may be necessary for the protection of users. Registrar Corp can review your device’s labeling for compliance with FDA regulations.

Drug Labeling and Ingredient Reviews

Among other aspects, FDA requires OTC drug labels to list active ingredients, drug uses, specific warnings and dosage instructions. Registrar Corp can review your drug’s labeling for compliance with U.S. FDA regulations.

Cosmetic Labeling and Ingredient Review

The FFDCA prohibits the distribution of misbranded cosmetic products. A cosmetic product is considered misbranded if its labeling claims are false or misleading, if it does not bear required information, or if the container is made or filled in a deceptive manner. Registrar Corp can review your cosmetic’s labeling for compliance with FDA regulations.

RED Labeling and Ingredient Review

FDA requires labels for radiation-emitting electronic devices (RED) to bear numerous aspects that may include warning statements, safety instructions, or servicing information. Registrar Corp can review your device’s labeling for compliance with FDA regulations.