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Warning Letter

RE: 593766

Dear Mr. Wood:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses https://doublewoodsupplements.com/products/dycetin-box and https://www.dycetin.com/ in June 2020 and observed that you take orders there for the product Dycetin. The claims on your websites 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 websites https://doublewoodsupplements.com/products/dycetin-box and https://www.dycetin.com/ that provide evidence that your product is intended for use as a drug include the following:

• “PREVENT HANGOVERS - No product is more proven or effective at preventing hangover symptoms including headaches, nausea, brain-fog, and anxiety.”
• “PROTECT YOUR LIVER AND BRAIN - Research shows Dycetin reduces alcohol induced damage to the liver and brain.”
• “Dycetin is the most effective hangover preventing supplement currently available.”
• “Not only does DHM [ingredient in Dycetin] enhance enzymes in the liver responsible for breaking down alcohol and its toxic by-products, but it also reduces the effect alcohol has on GABA receptors in the brain. This keeps you feeling more sober while drinking and greatly reduces hangover symptoms the next day.”

In addition, some of the claims on your website https://www.dycetin.com/ that provide further evidence that your product is intended for use as a drug include:

Home page:
• “Top Rated National Hangover Prevention Supplement”
• “NEVER SUFFER ANOTHER HANGOVER”
• “Dycetin tablets protect your liver and brain from alcohol, prevent hangovers . . .”

Buy Dycetin Now page:
• “ADVANCED HANGOVER PREVENTION FORMULA” (image of product label)
• “DYCETIN is a potent hangover prevention supplement which contains both Dihydromyricetin and a blend of electrolytes. It may reduce hangover symptoms by up to 99%.” (image of product label)
• “To reduce feelings of alcohol intoxication, take one tablet before you start drinking, and one additional tablet after finishing your first two drinks.” (image of product label)

How to Use Dycetin page:
• “Dycetin can be used in three main ways - to prevent hangovers after a night of drinking, to reduce feelings of intoxication while drinking, or to raise the alcohol intoxication threshold so you can have a few drinks without becoming intoxicated.”
• “Preventing Hangovers with Dycetin
To prevent hangovers with Dycetin, take 2 tablets at the end of the night with a large glass of water.”

• “Preventing Alcohol Intoxication
If you’ll be attending a social function where drinking is expected but you’d prefer not to become intoxicated, Dycetin can help. Simply take 2 tablets 30 minutes before drinking and you’ll be able to drink a 2-3 beers without noticing any intoxication.”

Dycetin FAQ page:
• “Dycetin is a natural scientifically proven hangover prevention supplement that blocks the affect alcohol has on the brain and allows the liver to process alcohol more quickly. Taking Dycetin after a night on the town will allow you to wake up feeling normal rather than being stuck in bed with a crippling hangover.”
• “Dycetin’s main ingredient, Dihydromyricetin, is the only single ingredient scientifically proven to prevent hangovers. It does this both by blocking alcohol’s effect on the brain’s GABA receptors and by allowing the liver to clear alcohol and its toxic byproduct acetaldehyde from the body at a much faster rate than normal. Combined, these effects allow Dycetin to prevent hangovers and reduce feelings of alcohol intoxication.”
• “To prevent a hangover, take 2 tablets of Dycetin before bed with a large glass of water.”

Your website https://www.dycetin.com/ also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Dycetin for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

• “This stuff really works. Either before you imbibe, or after. If you have had too much to drink, it will stop the spins, and staggers, and you don't get a hangover the next morning. It will knock out an existing hangover as well.”
• “I tried it before drinking once and it was like I was drinking non-alcoholic beer, I wasn't even phased. I take it at the end of a long night of partying on a weeknight and am up for work at 7 and even feel more tired than hungover at all. It also does well to take mid-drinking in order to keep from getting out of line.”

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 [email protected].

Sincerely,
/S/

William A. Correll Jr.
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

Cc:
18623 39th Dr. Se
Bothell, WA 98012-7691 US