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Warning Letter

RE: 593771

July 23, 2020

Dear Mr. Radziszewski:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses http://takepartypal.com and https://ebnsol.com/products/partypal-5-pack in June 2020 and observed that you take orders there for the product PartyPal^TM. 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 that provide evidence that your product is intended for use as a drug include the following:

On http://takepartypal.com:

• “How does it work and how did we create it?

Understanding the history of alcohol consumption led us to believe that throughout the ages different cultures have traditionally applied a variety of natural remedies for hangover relief and prevention as well as to help nullify the toll nightlife could have on the body.

We researched and tested dozens of these traditionally used natural remedies and ingredients from around the world. We tried and tested them separately and in different combinations and concentrations.

One tested combination of ingredients in unique concentrations proved uniquely effective against hangovers: Prickly Pear Cactus, Succinic Acid, and Oriental Raisin Tree. These three ingredients in our proprietary concentrations are what make up our 3Contrx® complex.”

On https://ebnsol.com/products/partypal-5-pack:

• “We bring you 3ContRx [ingredient blend in PartyPal], the most effective hangover treatments from 3 different parts of the globe all combined into easy to use tablets that REALLY WORK!”
• “THE SAFER WAY TO ENJOY CACTUS – Having a hangover can really ruin your day. Nausea, dry mouth, dizziness; all of these symptoms we know all too well. However, with Prickly Pear Cactus Extract [ingredient in PartyPal], you can say goodbye to the day-after woes! By reducing inflammation associated with a hangover and increasing the ability for your cells to repair themselves after a night of drinking debauchery, you can feel better right away!”
• “Dihydromyricetin, or DHM [ingredient in PartyPal], is a truly scientific way to prevent the dreaded hangover.”
• “GUARANTEED RELIEF – We take this product ourselves, and are proud to present it to you as a true hangover cure.”

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