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  5. BergaMet North America LLC - 636315 - 11/14/2022
  1. Warning Letters

WARNING LETTER

BergaMet North America LLC MARCS-CMS 636315 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Drugs
Recipient:
Recipient Name
Mr. Jay Decker
BergaMet North America LLC

6445 S. Tenaya Way Suite B110
Las Vegas, NV 89113-1989
United States

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

United States

WARNING LETTER

November 14, 2022

RE: 636315

Dear Mr. Jay Decker:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://bergametna.com in October 2022 and has determined that you take orders there for your Cholesterol Command product. We also reviewed your social media website,
www.facebook.com/BergametNorthAmerica.com which directs consumers to your website, https://bergametna.com to purchase your product. Additionally, we reviewed the product listing on www.walmart.com, where your product is available for purchase. 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 Cholesterol Command product page at https://bergametna.com/products/cholesterol-command:

  •  “BergaMet Cholesterol Command is clinically proven to improve cholesterol levels. It reduces LDL”
  •  “Anti-inflammatory”
  •  “Magnesium [an ingredient in Cholesterol Command] . . . Deficiency is related to . . . T2D [type 2 diabetes], chronic inflammation, heart disease and high blood pressure.”
  •  “Zinc [an ingredient in Cholesterol Command] . . . This key mineral has specific properties that may address inflammatory or immune system conditions.”
  •  “WHEN YOU ORDER BERGAMET . . . Take our supplements with confidence knowing that if they do not improve your LDL levels. You get 100% of your money back down to the penny.”

On your “What is Bergamot” page at https://bergametna.com/pages/learn-about-bergamot:

  •  “Reduces cholesterol”
  •  “Anti-Inflammatory Citrus Bergamot [an ingredient in your Cholesterol Command product] has been clinically shown to reduce inflammation.”

On your Walmart product page at https://www.walmart.com/ip/Citrus-Bergamot-Cholesterol-Command-80-Polyphenol-Formula-Supplement-Cholesterol-Heart-Health-Blood-Glucose-Levels-Highest-Strength/543149759:

  •  “BergaMet products follow the correct dosage and extract concentrations used and recommended in recent clinical studies as a bergamot supplement for high cholesterol . . . and help improve blood vessel function”

Your websites also contain evidence of intended use in the form of personal testimonials recommending or describing the use of Cholesterol Command for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

On your testimonial page at https://bergametna.com/pages/testimonials:

  •  “Love Cholesterol Command! My ldl is down 28 points, my doctor was extremely surprised because I am allergic to statins so working on my cholesterol levels has been difficult until I found out about BergaMet ... haven’t seen my cholesterol this low in 15 years”

On your Facebook page at www.facebook.com/BergametNorthAmerica.com:

  •  On a graphic titled “CAN CITRUS BERGAMOT [an ingredient in your Cholesterol Command product] IMPROVE YOUR CHOLESTEROL?” posted on March 14, 2022, you endorsed the following customer replies:

  o “Yes, it really works! my bad cholesterol drooped by 60 pts . . .” You endorsed this testimonial by responding, “That is amazing Jon! Thank you for sharing.”
  o “I have had amazing results with this supplement it brought down all my levels out of the red and into a very healthy range … this is the answer not a statin!” You endorsed this testimonial by responding, “that is AMAZING Lori! Thank you for sharing and congrats!”
  o “That’s what I use I stopped taking my prescription and my lab test number are great.” You endorsed this testimonial by responding, “That is great to hear Emmanuel! Thank you for sharing”
  o You also endorsed the following responses to your post by liking them:
    􀂃 “I just got my blood test back my total cholesterol went down 56 points and my bad cholesterol went down 82 points.”

  •  “Yes!! Mine went down 38 points.”

Your Cholesterol Command 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 Cholesterol Command 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, Cholesterol Command 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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