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July 23, 2020

Warning Letter
RE: 593770

Dear Mr. Shaw:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://happyhourvitamins.com/ in June 2020 and observed that you take orders there for the product Happy Hour Vitamins (H2V). FDA also observed that you sell this product on Amazon.com at https://www.amazon.com/gp/product/B00M2F1NNY/ref=as_li_tl?ie=UTF8&camp=1789&creative=9325&creativeASIN=B00M2F1NNY&linkCode=as2&tag=happyhourvita-20&linkId=DCFNNAEYLGHEN7D7&th=1 (“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://happyhourvitamins.com/ that provide evidence that your product is intended for use as a drug include the following:

Home page:
• “Multivitamin Specially Formulated to Help with Hangovers.”
• “Specially formulated to help you Avoid Hangovers . . .”
• “HELPS AVOID HANGOVERS!” (image of product label)
• “MULTIVITAMIN SPECIALLY FORMULATED TO HELP YOU AVOID HANGOVERS”
• “Convenient individual packets makes hangover prevention easy by taking 1 dose (2 hangover pills) before/while drinking.”
• “KILL YOUR HANGOVER BEFORE IT EVEN STARTS with powerful vitamin, mineral, anti-oxidant, herbal blend. Preventing hangovers works better than a hangover cure or cures you can try.”
• “GET RID OF TOXIC ACETALDEHYDE POISONING that adds to your hangovers with N-acetyl Cysteine [ingredient in Happy Hour Vitamins (H2V)]. Protect your liver with milk thistle, kudzu flower powder, and artichoke leaf extract [ingredients in Happy Hour Vitamins (H2V)]. Paired with water makes the perfect hangover kit.”
• “These are the hangover cure pills you are looking for!”
• “Hangovers are much more than just dehydration . . . Headache often occurs when alcohol in the bloodstream absorbs all the vitamins and nutrients from the body’s organs. The shortage of vitamins and nutrients leads to organ dehydration, after which the organs begin to steal hydration from the brain. When this happens, the brain actually shrinks and the blood vessels become inflamed, making it harder for blood to flow through the brain and causing immense pressure.
Solution: Take in a healthy dose of vitamins & nutrients prior to drinking”
• “Hangovers are much more than just dehydration . . . Diarrhea, Nausea, and Vomiting all go hand in hand. For some, simply binge eating while drinking lots of alcohol causes an awful upset stomach. The body’s reaction to all the toxins from alcohol coupled with dehydration amplifies these symptoms as well. Acute or chronic binge drinkers can develop normal bouts of diarrhea from chronic ethanol ingestion. While vomiting is very unpleasant, it is the body’s natural defenses in action. So for many, vomiting may help ease symptoms of hangover to an extent. These are truly the hangover vitamins you need.”

How H2V Works page:
• “Antioxidants can help the body deal with toxins & other effects from alcohol

Your body will thank you for the Antioxidant rich Acai Berry, Goji Berry & Green Tea extracts which are all part of Happy Hour Vitamins cutting edge proprietary blend.

Here is an excerpt from Annals of Internal Medicine examining the staggering cost of hangovers (Wiese et al. 2000)

‘The staggering cost of alcoholic hangover could be significantly mitigated if drinkers took the right antioxidants before going to bed.’”
• “Happy Hour Vitamins contains Thiamine which has been used to help calm the effects of alcohol withdrawal syndrome.”
• “Avoid Hangovers . . . with Happy Hour Vitamins”

Our Story page:
• “I started thinking that it would be great if there was a multivitamin specifically formulated for the drinking population. One that would help support the bar industry lifestyle by focusing on . . . the reduction of hangover symptoms. . . . So, I hired people much smarter than myself to create Happy Hour Vitamins . . .”
• “HOW TO STOP THE STRUGGLE WITH HANGOVERS
Here is what makes Happy Hour Vitamins specific formulation for the drinking population so special . . .”

Bars & Resellers page:
• “With the H2V Partner Program, you can start making more money by selling the most effective hangover cure on the market.”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Happy Hour Vitamins (H2V) for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

• “I struggled with hangovers while working as bartender for over a decade. Striving to find a hangover cure, I hired a PhD chemist and consulted medical professionals to create Happy Hour Vitamins, hangover vitamins. Now Happy Hour Vitamins allow me to avoid my hangovers . . .” (Home page)
• “I got these for my wedding ‘Emergency Hang-over Kits’. They work wonders; everyone was so excited to wake up the next morning and not feel sluggish or tired or have a major headache.” (Home page)
• “I keep the packets in my purse and when I start drinking I just take them its [sic] as easy as that and bam no hangover!” (How H2V Works page)
• “I am a bartender and always advise my customers to take a couple before beginning their shenanigans for the evening. They always come back and thank me for introducing them to Happy Hour Vitamins. I tell them that is easy to sell, no one wants a hangover!” (Bars & Resellers page)

Also, claims made on your Amazon sale page https://www.amazon.com/gp/product/B00M2F1NNY/ref=as_li_tl?ie=UTF8&camp=1789&creative=9325&creativeASIN=B00M2F1NNY&linkCode=as2&tag=happyhourvita-20&linkId=DCFNNAEYLGHEN7D7&th=1 provide further evidence that your product is intended for use as a drug. For example:

• “Happy Hour Vitamins Formulated for Hangovers . . .”
• “HELPS AVOID HANGOVERS!” (image of product label)
• “HAPPY HOUR VITAMINS IS A MULTIVITAMIN SPECIALLY FORMULATED TO HELP WITH HANGOVERS. Convenient individual packets makes hangover prevention easy by taking 1 dose (2 hangover pills) before/while drinking. On days of extended drinking we suggest a second dose later in the evening. Forgot to take Happy Hour Vitamins and woke up Hungover? Take a pack of Happy Hour Vitamins as your hangover cure!”
• “These are the hangover pills you need for the perfect wedding, bachelor, bachelorette, vacation, party or everyday hangover kit!”
• “KILL YOUR HANGOVER BEFORE IT EVEN STARTS with powerful vitamin, mineral, electrolyte, anti-oxidant, herbal blend now with prickly pear extract! Preventing hangovers works better than a hangover cure or cures you can try.”
• “GET RID OF TOXIC ACETALDEHYDE POISONING that adds to your hangovers with N-acetyl Cysteine [ingredient in Happy Hour Vitamins (H2V)]. Protect your liver with milk thistle, kudzu flower powder, and artichoke leaf extract [ingredients in Happy Hour Vitamins (H2V)]. Paired with water makes the perfect hangover kit.”
• “Avoiding hangovers is easy with Happy Hour Vitamins, just take 1 dose (2 capsules) before/while drinking to help you the next morning.”
• “Forgot to take Happy Hour Vitamins and woke up hungover? Take 1 dose (2 hangover pills) with water to help you get back on track as your hangover cure!”
• “We were tired of hangovers and figured there had to be a better way. So we hired a chemist, domestic manufacturer & consulted medical professionals.”
• “The Only Thing You Have To Lose Is Your Hangover!”

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.

Based on the product label on your website, it appears that you intend to market your Happy Hour Vitamins (H2V) product, which contains N-acetyl-L-cysteine (NAC), as a dietary supplement. However, even if your product labeling did not have therapeutic claims that make your product an unapproved new drug, your product could not be a dietary supplement, because it does not meet the definition of dietary supplement under section 201(ff) of the Act [21 U.S.C. § 321(ff)]. FDA has concluded that NAC products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)]. Under this provision, if an article (such as NAC) has been approved as a new drug under section 505 of the Act [21 U.S.C. § 355], then products containing that article are outside the definition of a dietary supplement, unless before such approval that article was marketed as a dietary supplement or as a food. NAC was approved as a new drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963. FDA is not aware of any evidence that NAC was marketed as a dietary supplement or as a food prior to that date.

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:
27 N. Front St. Ste 200
Wilmington, NC 28401-4483 US