Healthy Trends Worldwide, LLC – FDA Warning Letter, Nov 17, 2022
The FDA issued a Warning Letter to Mr. Manuel Alayon regarding the BPS-5 product sold on goldenafter50.com and promoted on Facebook and YouTube. An October 2022 review of these websites revealed claims establishing BPS-5 as a drug 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 its intended use in the cure, mitigation, treatment, or prevention of disease.
Specific claims cited include "help lower your blood pressure," "lower your high blood pressure naturally and fast," and "Hawthorn Berry [an ingredient in BPS-5] fights back against blood pressure, blood disorders, and heart disease."
BPS-5 is deemed a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)] because it is not generally recognized as safe and effective for its stated uses. Introducing a new drug into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].
Furthermore, BPS-5 is misbranded under section 502(f)(1)
ID · 5551db5b-a8ba-4e39-93ca-26525faa15e6
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