WARNING LETTER
Mind, Body & Coal LLC
MARCS-CMS 593774 —
July 23, 2020
Product:
Dietary Supplements
Recipient:
Recipient Name
Lisa Smith
Recipient Title
CEO
Mind, Body & Coal LLC
2920 Bayshore Vista Drive
Tampa
,
FL
33611
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
July 23, 2020
Warning Letter
RE: 593774
Dear Ms. Smith:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://miracoal.com/ in June 2020 and observed that you take orders there for the product Miracoal – Ultimate Hangover Relief and Total Body Detox. FDA also observed that you sell this product on Amazon.com at https://www.amazon.com/Miracoal-Hangover-Prevention-Relief Pills/dp/B075RHP8MG/ref=sr_1_2_sspa?keywords=miracoal&qid=1570454206&sr=8-2-spons&psc=1&spLa=ZW5jcnlwdGVkUXVhbGlmaWVyPUEzMTQzQTNKVVFHV0FGJmVuY3J5cHRlZElkPUEwMDU1ODQ1MjBVRTlZRFpaUlU4TSZlbmNyeXB0ZWRBZElkPUEwMjM3MDc4QUtYTlRQWVAwQUhLJndpZGdldE5hbWU9c3BfYXRmJmFjdGlvbj1jbGlja1JlZGlyZWN0JmRvTm90TG9nQ2xpY2s9dHJ1ZQ== (“your Amazon sale page”). The claims on your website and Amazon sale page establish that the 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 claims on your website https://miracoal.com/ that provide evidence that your product is intended for use as a drug include the following:
• “Ultimate Hangover Relief” (Home page and image of product label)
• “PUT YOUR HANGOVER TO BED” (Home page)
• “Miracoal is the only product on the market that takes this healing process to the next level combining the purest form of organic coconut charcoal with electrolytes to flush away toxins and impurities in your digestive system and provide fast detoxifying rejuvenation, helping you wake up hangover-free.*” (Miracoal – Ultimate Hangover Relief & Total Body Detox product page)
• “We know that hangovers don’t concede to a demanding schedule or life. . . .
. . . we have researched, created and patented an effective formula that detoxes impurities from your system and provides fast-acting relief the woes of a night well spent.
So we invented our ‘Miracoal’ and set out to change the world, one hangover at a time.” (Our Story page)
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Miracoal – Ultimate Hangover Relief and Total Body Detox for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
• “I love using Miracoal! I don’t drink often but every time I do I use Miracoal and I’m back to business in the morning. No hangover feelings at all!" (Testimonials page)
• ". . . Then I found Miracoal! Now when I go out, if I have a few cocktails, I just take my Miracoal before I go to bed. I wake up the next morning hangover-free and ready to tackle my day!" (Testimonials page)
Also, claims made on your Amazon sale page https://www.amazon.com/Miracoal-Hangover-Prevention-Relief Pills/dp/B075RHP8MG/ref=sr_1_2_sspa?keywords=miracoal&qid=1570454206&sr=8-2-spons&psc=1&spLa=ZW5jcnlwdGVkUXVhbGlmaWVyPUEzMTQzQTNKVVFHV0FGJmVuY3J5cHRlZElkPUEwMDU1ODQ1MjBVRTlZRFpaUlU4TSZlbmNyeXB0ZWRBZElkPUEwMjM3MDc4QUtYTlRQWVAwQUhLJndpZGdldE5hbWU9c3BfYXRmJmFjdGlvbj1jbGlja1JlZGlyZWN0JmRvTm90TG9nQ2xpY2s9dHJ1ZQ== provide further evidence that your product is intended for use as a drug. For example:
• “ULTIMATE HANGOVER RELIEF” (image of product label)
• “Miracoal Hangover Prevention and Relief Pills”
• “Each capsule offers much more than just hangover relief . . .”
• “THE ULTIMATE HANGOVER PREVENTION”
• “Activated charcoal [ingredient in Miracoal – Ultimate Hangover Relief & Total Body Detox] removes impurities from your digestive system, helping you recover from drinking and put your hangover to bed!”
• “We’ve harnessed its [charcoal’s] healing powers into an easy-to-use capsule, formulated specifically to provide easy hangover relief and prevention.”
• “You’ll wake up feeling . . . hangover-free!”
• “Since activated charcoal has long been considered a safe and effective treatment for acute toxic poisoning, we've turned it into a powerful new hangover prevention pill.”
A statement claims to mitigate, treat, cure, or prevent disease if it claims, explicitly or implicitly, that the product has an effect on the characteristic signs or symptoms of a specific disease or class of diseases [see 21 CFR 101.93(g)(2)(ii)]. A hangover is a sign or symptom of alcohol intoxication, a disease. Like all poisonings, alcohol intoxication causes dose-related dysfunctioning and damage, ranging from mild impairments to death. Alcohol intoxication causes temporary damage to brain function, causing impairments of judgment, attention, reflexes, and coordination. Therefore, alcohol intoxication meets the definition of disease in 21 CFR 101.93(g)(1) [see 65 Fed. Reg. 1000, 1015 (Jan. 6, 2000)].
Your 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)]. 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.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, 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 that you have taken to correct the violations described in this letter and to prevent similar violations. Include any documentation necessary to show that correction has been achieved. 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 products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Your reply should be sent via e-mail to
FDAAdvisory@fda.hhs.gov
.
Sincerely,
/S/
William A. Correll Jr.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Cc:
PO BOX 130894
TAMPA, FL 33681
Content current as of:
07/29/2020
Regulated Product(s)
Dietary Supplements