FDA Labels
FDA Compliance, today.
FDA COMPLIANT LABELS

The FDA will not focus on enforcement actions related to Nutrition and Supplement Facts labels, because the agency intends to facilitate the distribution of food during the COVID-19 pandemic.

However, it is always in your company’s best interest to have compliant labels for food and other FDA regulated products.

Dietary Supplement Labeling

If an article or substance, such as Cannabidiol (CBD), is an active ingredient in a drug product that has been approved, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.

There is an exception, if the substance was “marketed as” a dietary supplement or as a conventional food, before the new drug investigations were authorized.

Drug Labeling

We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not representing your products as safe and/or effective for a COVID-19-related use for which they have not been licensed, approved, cleared, or authorized by FDA, and that you do not make claims that adulterate or misbrand the products.

Furthermore, it is unlawful under the FTC Act, to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true when they are made.

At this time, any coronavirus-related prevention or treatment claims regarding such products are not supported by competent and reliable scientific evidence.

Otherwise, your domestic or foreign firm will be added to a published list on FDA’s website, of companies that have received Warning Letters concerning the sale or distribution of COVID-19 related products, in violation of the FD&C Act.

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