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Posted November 29, 2019

FDA Warns Seller of "All Natural" Treatment for Opioid Withdrawal, Migraines & More

On November 18, 2019, the FDA issued a warning letter to EPH Technologies, Inc., following a review of the company's websites, which found statements made about some of the company's products, including Detoxoplex, Sinople, and Migrenz, to be drug claims.

The products have been sold through the company's website and on under the category of dietary supplements. They are labeled as containing a "proprietary blend of all natural proteins, enzymes, amino acids, minerals and peptides" and are promoted to reduce symptoms of opioid withrdrawal, sinus infections and congestion, hangovers and migraine. For example, Detoxoplex was promoted with statements such as "[R]educing: symptoms typically associated with withdrawal from opioid use. "Sinople was promoted with statements such as "[R]educing: symptoms commonly associated with allergies, congestion, nausea, migraines, headache, hangover, colds, dizziness."

The agency warned that the products are considered to be "new drugs" because "they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling." The products were also found to be misbranded because the product labels do not provide adequate directions for use. The company must respond to the FDA in writing explaining the specific steps it has taken to correct these violations.

For information about other proposed natural treatments for these conditions, see CL's Answers to the questions: Which supplements are best for seasonal allergies? and Do any supplements help with migraines?

See related warnings:

Seller of Apple Cider Vinegar, Joint Supplements & More Warned for Drug Claims

Seller of Maca Powder Warned for Drug Claims

Seller of Vitamin D, Omega-3's, Whey Protein & More Warned for Drug Claims

Seller of Supplements for Pain and Allergies Warned for Manufacturing Violations, Drug Claims

Seller of Coenzyme-A Warned For Making Drug Claims

Marketers of CellAssure and Cognify Settle FTC Charges of Deceptive Cancer Claims

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