WARNING LETTER
Purple Biosciences, LLC
MARCS-CMS 593772 —
July 23, 2020
Product:
Dietary Supplements
Recipient:
Recipient Name
Monir Elias
Recipient Title
CEO
Purple Biosciences, LLC
12636 High Bluff Dr. Ste 400
San Diego
,
CA
92130-2071
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
July 23, 2020
Warning Letter
RE: 593772
Dear Mr. Elias:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://gotpurpletree.com/ in June 2020 and observed that you take orders there for the product Purple Tree. FDA also observed that you sell this product on Amazon.com at https://www.amazon.com/Hangover-Prevention-Dihydromyricetin-L-Cysteine-California/dp/B072HGQC4X (“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://gotpurpletree.com/ that provide evidence that your product is intended for use as a drug include the following
• “Purple Tree® is a natural multivitamin specifically designed to reduce alcohol's negative effects in the body . . . Hangovers hinder our work, fitness and family routines, so we embarked on a mission to help health-conscious adults who drink . . .” (FAQs page)
• “Yes, Purple Tree is a hangover prevention pill that works.” (FAQs page)
• “Although a hangover cure for heavy-drinking situations like this does not exist, Purple Tree surely helps to mitigate some of the hangover symptoms, if taken beforehand.” (FAQs page)
• “Purple Tree’s key ingredient is called Dihydromyricetin (DHM), an extract from the Japanese Raisin Tree, which has been used for centuries as an anti-alcohol herb and hangover cure in Asia.” (How it Works page)
• “Say Goodbye to Hangovers . . . SHOP NOW” (appears next to image of the Purple Tree product on the Journal page)
• “Purple Tree – Supplement for Hangover Prevention” (Hangover Pills product page)
• “Our hangover prevention pills were crafted by Doctors and Scientists with vast experience in natural supplements.” (Hangover Pills product page)
Also, claims made on your Amazon sale page https://www.amazon.com/Hangover-Prevention-Dihydromyricetin-L-Cysteine-California/dp/B072HGQC4X provide further evidence that your product is intended for use as a drug. For example:
• “Purple Tree Hangover Cure & Prevention Pills”
• “HELPS PREVENT HANGOVER SYMPTOMS”
• “Purple Tree’s science-backed formula includes Dihydromyricetin (DHM), a liver detox and hangover prevention ingredient. DHM is a natural extract that has been used as anti-alcohol herb and hangover cure since ancient medicine.*”
• “Purple Tree helps to prevent hangover symptoms . . .”
• “Key Benefits . . . helps to combat alcohol’s negative effects in the body, including hangover*”
• “Key Ingredients
o Dihydromyricetin (DHM) is derived from the Japanese Raisin Tree (Hovenia Dulcis) – it has been used for centuries as an anti-alcohol herb and hangover cure in Asia.*
o White Willow Bark, also called ‘Nature’s Aspirin’, acts as a natural anti-inflammatory agent in the human body.*
o Milk Thistle helps to protect the liver from damage.*”
• “Our hangover prevention pills were crafted by Doctors and Scientists with vast experience in natural supplements.”
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 Purple Tree® 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
FDAAdvisory@fda.hhs.gov
.
Sincerely,
/S/
William A. Correll Jr.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Cc:
4329 Graydon Rd
San Diego, CA 92130-2432 US
Content current as of:
07/29/2020
Regulated Product(s)
Dietary Supplements