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  5. Chill6 - 611422 - 07/20/2021
  1. Warning Letters

WARNING LETTER

Chill6 MARCS-CMS 611422 —

Delivery Method:
United Parcel Service
Product:
Drugs
Recipient:
Recipient Name
Mr. Dan Marold
Chill6

26 Valley Forge Cir.
West Boylston, MA 01583
United States

Issuing Office:
Office of Human and Animal Food Operations East – Division 1

United States

WARNING LETTER
CMS# 611422


Dear Mr. Marold:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.chill6.com in July 2021 and has determined that you take orders there for the product Chill6, including flavors Margarita Lime, Watermelon Jolly, Orange Mango, and Pink Lemonade. The claims on your website 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. Additionally, even if your Chill6 were not an unapproved new drug and misbranded drug, it would be an adulterated food and misbranded food, as described below.

Introducing or delivering these products 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.

Unapproved New Drug and Misbranded Drug

Examples of some of the claims that provide evidence that your products are intended for use as drugs include:

Within the Chill6 homepage of your website (https://www.chill6.com/):

  • “Did you know Chill6™ is great to lower anxiety during benzo and alcohol withdrawal?”
  • “Phenibut [which you list as an ingredient in Chill6] has been used safely in Russia for over 50 years . . . safely treating hundreds of thousands of people for a variety of disorders, including; anxiety, insomnia, . . . alcoholism and post-traumatic stress disorder (PTSD).”
  • “It [L-taurine] just might however contend as one of the healthiest amino acids for your body, offering a very long list of health benefits, including . . . cholesterol lowering affects.”

Within the Chill6 FAQs section of your website (https://www.chill6.com/pages/faqs):

  • “Chill6™ is a great anti-anxiety drink . . .. But Chill6™ is literally an anti anxiety, (it doesn’t make you calm, it takes away your anxiety therefore any anxiety related ailment would be worth a try [sic]. Chill6™ has helped many soldier’s (sic) with PTSD, and is outstanding for socially anxiety . . .. Additionally, Chill6™ reduces anxiety produced by benzodiazepine and alcohol withdrawal symptoms for people trying to reduce their physical addiction to them. This is often done by doctor's [sic] when withdrawing someone from alcohol. The doctor will prescribe a benzodiazepine to heighten the seizure threshold and reduce agonizing withdrawal symptoms.”

Within the Our Mission section of your website (https://www.chill6.com/pages/teamchill6):

  • “Chill6™ was discovered after one man found great success with a blend of amino acids that reduced his anxiety and vitalized his body while coming off his current prescription strength anti anxiety medication (benzodiazepines). The result Chill6™, the world’s first anti-anxiety & vitality drink, made from six amino acids.”
  • “. . . Chill6™ users see this is a serious product, with amazing benefits, in just over 5 years selling Chill6™, we have many physicians worldwide who recommend Chill6™ for various anxiety related ailments.”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Chill6 for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

Within the Chill6 testimonials section of your website (https://www.chill6.com/pages/testimonials):

  • “I’m . . . an all around anxious lady, a Zoloft patient and I’M also prescribed Lorazepam to use as needed. I haven’t touched my latest prescription. That’s how good this is.”
  • “Our home consists of 3 PTSD cases and high anxiety. Pharmaceuticals made us worse. Chill6 has made a world of difference for all 3 of us.”
  • “I have been suffering from anxiety for years...this is the ONLY non narcotic I have ever tried that has 100% worked with no side effects.”

Your Chill6 product (all flavors) 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). With certain exceptions not applicable here, 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) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your Chill6 product (all flavors) is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, Chill6 (all flavors) fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].

Adulteration – Unsafe Food Additive

Even if your Chill6 product, all flavors, was not an unapproved new drug and misbranded drug, it would be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because it contains phenibut HCl, an unsafe food additive under section 409(a) of the Act [21 U.S.C. § 348(a)]. If a substance added to food is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition, it is a food additive.1 Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(C)(i)].

The definition of “food additive” in section 201(s) of the Act [21 U.S.C § 321(s)] does not include dietary ingredients used in dietary supplements as defined in section 201(ff)(1) of the Act [21 U.S.C § 321(ff)(1)] or substances that are GRAS under the conditions of intended use. This exception from the food additive definition does not apply here for two reasons: first, Chill6 is not a dietary supplement; second, phenibut HCl is neither a dietary ingredient nor GRAS under the conditions of intended use.

With regard to Chill6, while the product label includes a statement of identity as a “dietary supplement,” your website, www.chill6.com, depicts the product with the statements “vitality drink" and “anti anxiety drink” and a vignette of the product jars with a filled beverage glass for each Chill6 product flavor, accompanied by slices of fruit which represent the flavors of the products. These statements and vignettes contextually imply that this product is to be used as a beverage—i.e., as a conventional food. Under section 201(ff)(2)(B) of the Act, a dietary supplement is a product that “is not represented for use as a conventional food.” Because you represent Chill6 as a conventional food, it is not a dietary supplement. Therefore, phenibut HCl cannot be a dietary ingredient used in a dietary supplement.

Furthermore, even if Chill6 were a dietary supplement, phenibut HCl does not qualify as a dietary ingredient under section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)] because it is not a vitamin, mineral, amino acid, herb or other botanical, dietary substance for use by man to supplement the diet by increasing the total dietary intake, or concentrate, metabolite, constituent, extract, or combination of any of the preceding dietary ingredient types. Neither is phenibut HCl GRAS under its conditions of use in your dietary supplement product. Because phenibut HCl does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your Chill6 product (all flavors) is adulterated under section 402(a)(2)(C)(i) of the Act because it contains an unsafe food additive. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under section 301(a) of the Act [21 U.S.C. § 331(a)].

Misbranded Foods

Even if your Chill6 product (all flavors) were not an unapproved new drug and a misbranded drug, it would be a misbranded food under section 403(a)(1) of the Act. The label of your Chill6 product (all flavors) declares the product to be a dietary supplement. However, as explained above, your Chill6 product is represented on your website Chill6.com as a conventional food. Because the definition of dietary supplement states that a dietary supplement is not a product represented as a conventional food, Chill6 is not a dietary supplement [see section 201(ff)(2)(B) of the Act]. Declaring Chill6 to be a dietary supplement is therefore false or misleading and misbrands the product under section 403(a)(1) of the Act. The introduction or delivery for introduction into interstate commerce, or causing thereof, of such misbranded products is prohibited under section 301(a) of the Act.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the U.S. Food and Drug Administration, Attention: Scott R. Izyk, Compliance Officer, 1 Winners Circle, Suite 110, Albany, NY 12205 or by e-mail to scott.izyk@fda.hhs.gov.

Sincerely,
/S/

Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East –
Division 1

_______________________________

1 Under section 201(s) of the Act [21 U.S.C. § 321(s)], the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food; (2) pesticide chemicals; (3) color additives; (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the Act, the Poultry Products Inspection Act, or the Meat Inspection Act; (5) new animal drugs; and (6) dietary ingredients in or intended for use in a dietary supplement.

 
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