WARNING LETTER
Adaptive Energy LLC
MARCS-CMS 553626 —
September 06, 2018
Recipient:
Adaptive Energy LLC
109 E 17th St. Ste 4
Cheyenne
,
WY
82001
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
5001 Campus Drive
College Park, MD 20740-3835
WARNING LETTER
SEP 6, 2018
VIA EXPRESS DELIVERY
Adaptive Energy LLC
109 E 17th St. Ste 4
Cheyenne, Wyoming 82001
Re: 553626
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.purblack.com in July 2018 and has determined that you take orders there for the product Purblack. 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. 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 website claims that provide evidence that your Purblack
product is intended for use as a drug include:
“Aids in fighting addictions”
“Unique resins like Purblack, aid in fighting numerous addictions; not just to opioids, but cannabis and pain pills, as well.”
“There’s a reason that eastern medicine has been prescribing shilajit for centuries to stop addictions.”
Your Purblack product is not generally recognized as safe and effective for the above referenced uses and, therefore, the 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.
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
Purblack product 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, the Purblack product 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)].
The above violations are not intended to be an all-inclusive list of violations that exist in connection with your product. You are responsible for ensuring that all of your products are in compliance with the Act and all applicable FDA regulations. You should take prompt action to correct the violations cited above and to prevent their reoccurrence. Failure to do so may result in legal action without further notice, including seizure and/or injunction.
Please respond in writing within fifteen (15) working days of receipt of this letter. Your response should outline the specific steps you are taking to correct these violations, including any steps with respect to product currently in the marketplace. Your response should also include an explanation of steps you are taking to ensure that similar violations do not recur.  You should include documentation to support your response and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
You should direct your written reply to Shawn Goldman, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Mr. Goldman via email at
Shawn.Goldman@fda.hhs.gov
. Please reference CMS# 553626 on any submissions and on the subject line of any emails to us.
Sincerely,
/S/
William A. Correll Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
09/18/2018