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  5. Healthy Trends Worldwide, LLC - 636401 - 11/14/2022
  1. Warning Letters

WARNING LETTER

Healthy Trends Worldwide, LLC MARCS-CMS 636401 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Drugs
Recipient:
Recipient Name
Manuel Alayon
Healthy Trends Worldwide, LLC

11011 Spring Point Cir
Riverview, FL 33579-4303
United States

support@goldenafter50.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

WARNING LETTER

November 14, 2022

RE: 636401

Dear Mr. Manuel Alayon:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://goldenafter50.com in October 2022 and has determined that you take orders there for your BPS-5 product. We also reviewed your social media websites, www.facebook.com/goldenafter50/ and https://www.youtube.com/watch?v=ZvDDRnKe8cY, which direct consumers to your website https://goldenafter50.com to purchase your product. The claims on your websites establish that this product is 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)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the website claims that provide evidence that your product is intended for use as a drug include the following:

On your BPS-5 product page at www.goldenafter50.com/product/bps-5/

  • “That’s why we combined five science-backed ingredients from nature that address multiple factors to help regulate blood pressure.”

On your Facebook website at www.facebook.com/goldenafter50/

  • Posted on July 4, 2022 with a graphic stating “REDUCE BLOOD PRESSURE”: “If you can correct your blood pressure, you can likely add a healthy 10, 15, even 20+ years to your life... In today’s video, you’ll learn 5 simple ways to lower blood pressure naturally.” This post links to your YouTube video at https://www.youtube.com/watch?v=ZvDDRnKe8cY in which you recommend your BPS-5 product to reduce high blood pressure, as described below.

On your YouTube video at https://www.youtube.com/watch?v=ZvDDRnKe8cY

  • (0:00-0:15) “Hey there it’s Jared from GoldenAfter50.com and if you have high blood pressure or know someone with high blood pressure then don’t go anywhere because today I’m going to reveal five simple ways you can lower your blood pressure fast…”
  • (2:57-3:08) “Now next is Hawthorn Berry [an ingredient in your BPS-5 product]. Used in traditional Chinese medicine for thousands of years, Hawthorn Berry is a popular ingredient used to fight back against blood pressure, blood disorders, and heart disease.”
  • (4:00-4:24) “For example, just two of these ingredients, Hawthorn Berry and magnesium, we use in our own nature-based blood pressure support formula called BPS-5. We stopped at nothing to create a formula like this because of this runaway epidemic in this country.”
  • In the written video description of your YouTube video:

    o “There are many different ways out there to help lower your blood pressure. That is why I want to give you 5 simple ways you can lower your high blood pressure naturally and fast.”
    o “Tip #4: HAWTHORN BERRY [an ingredient in your BPS-5 product]. This fights back against blood pressure, blood disorders, and heart disease.”
    o “2 of these ingredients, Hawthorn Berry and Magnesium are in our nature based blood pressure support formula called BPS-5. Click here to learn more about BPS-5: https://goldenafter50.com/product/bps-5/”

Your BPS-5 product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your product BPS-5 is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, BPS-5 fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in legal action including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address these matters. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written reply should be directed to Dr. Aaron Dotson, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835 or via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.

Sincerely,
/S/

Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition
Food and Drug Administration

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