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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
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
Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
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Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
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