# FDA WARNING_LETTER - Speedwinds Nutrition, Inc. - December 22, 2020

Source: https://www.keypedia.com/records/warning_letter/speedwinds-nutrition-inc/446cfd86-bc6e-432c-8c4f-bda812393c38

> FDA WARNING_LETTER for Speedwinds Nutrition, Inc. on December 22, 2020. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Speedwinds Nutrition, Inc.
- Inspection Date: 2020-12-22
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: The FDA issued a Warning Letter to Speedwinds Nutrition, LLC, on December 22, 2020, following a review of their websites (www.speedwinds.com, www.speedwindsnutrition.com, www.synotrex.com, www.sephren.com) and Amazon storefront in December 2020. The FDA determined that the products Synotrex and Sephren are unapproved new drugs and misbranded.

The products are deemed drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] due to claims on their websites and Amazon storefront indicating their intent for use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims for Synotrex include reducing joint pain, rebuilding cartilage, treating osteoarthritis, and alleviating chronic pain. For Sephren, claims include stopping the root causes of female hair loss related to various medical conditions. Testimonials and media quotes on www.synotrex.com further support these drug claims.

Since Synotrex and Sephren are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] and require prior FDA approval, which they

## Related Officers

- [Miriam R. Burbach](https://www.keypedia.com/people/miriam-r-burbach/68959b72-6f58-4d4b-9329-5109ffe8a649)

Company: https://www.keypedia.com/companies/speedwinds-nutrition-inc/617445d3-5cce-4bdb-96f7-e46f14ed1db5

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822