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Posted December 15, 2020

FDA Warns Seller of Evening Primrose Oil and Beta Glucan

On December 2, 2020, the FDA issued a warning letter to Smoky Mountain Naturals, LLC following a review of the company's website, which found statements made about the company's products Evening Primrose Oil and Beta Glucan to be drug claims.

For example, Evening Primrose Oil was promoted with statements such as "Evening Primrose Oil has been traditionally used for:

  • Psoriasis
  • Eczema
  • Inflammation-related Acne
  • High Blood Pressure"

See ConsumerLab's Black Currant Oil, Borage Oil, Evening Primrose Oil, Flaxseed Oil, and Hemp Oil Supplements Review (Sources of ALA and GLA) for tests of related products.

Beta Glucan was promoted with statements such as "Beta Glucan supplements taken orally can help prevent sickness and support faster recovery from viruses."

See ConsumerLab's Reishi Mushroom Supplements Review for tests of related products.

In addition, these two products were found to be misbranded because they does not contain adequate directions for safe use, as required by federal regulations.

For more information, use the link below.

Warning Letter: Smoky Mountain Naturals, LLC

See related warnings:

FDA Warns Seller of Curcumin and Cholesterol Supplements

FDA Warns Immusist for Drug Claims

FDA Warns Seller of Digestive Enzymes, Nattokinase, and More

Seller of Cholesterol-Lowering Supplements Warned for Drug Claims