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Posted May 24, 2023

Seller of Echinacea, High Blood Pressure Products & More Warned for Drug Claims

On May 12, 2023, the FDA issued a warning letter to H.E.A.L. Marketplace following inspection of the company’s websites, which found statements made about the company’s Antispasmodic Tincture, Echinacea Tonic, High Blood Pressure II, and Insomnia Formula products to be drug claims.

For example, the company’s Echinacea Tonic was promoted with statements such as “Echinacea’s cold and flu fighting and healing ability alone has made it the #1 immune herb…” and “[Echinacea Tonic] should be used for EVERY disease and illness.”

See ConsumerLab’s Echinacea Supplements Review for more information and tests of related products.

In addition, the FDA found certain H.E.A.L. products to be misbranded because the product labels did not include adequate directions for use, as is required by federal regulations.

The company is required to respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

Also see:

What are the best supplements or lifestyle modifications for sleep, and which can make insomnia worse?

Which supplements can help to lower blood pressure?

For more information, use the link below.

Warning: H.E.A.L. Marketplace

See related recalls and warnings:

Oregon’s Wild Harvest Warned by FDA for Manufacturing Violations

FDA Warns Seller of Ginger, Echinacea, and More

Traditional Medicinals "Throat Coat" Lemon Echinacea Herbal Tea Recalled in Canada

FDA Warns Saffron USA for Promoting Teas to Treat Insomnia, Osteoporosis & Cancer