Inspections, Compliance, Enforcement, and Criminal Investigations

Peak Nootropics LLC (aka Advanced Nootropics) 2/5/19

 

  

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WARNING LETTER
 
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
February 5, 2019
 
Peak Nootropics LLC (aka Advanced Nootropics)
Dennis B. Butts, Owner
13507 Saint Mary’s Ln.
Houston, TX 77079
 
Dear Mr. Butts:
 
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.peaknootropics.com in September 2018 and has determined that you take orders there for your products Adrafinil, Aniracetam, Bacopa Monnieri, L-Dopa, L-Theanine, Noopept, Oxiracetam, Phenibut, Phenylpiracetam, Piracetam,[1] Rhodiola Rosea, and Uridine. The claims on your websites establish that these products are drugs under section 201(g)(1)(B) and/or (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or any function of the body. [2] As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. Pramiracetam,
 
Examples of some of the website claims that provide evidence your products are intended for use as drugs include the following:
 
On the “Adrafinil” page of your website:
  • “People who have taken Adrafinil have suggested that it greatly improves cognition and memory. It can be used in times of high mental demand to help promote focus and mental alertness. There is evidence that Adrafinil can help with focus and even assist with ADHD symptoms. It should in no way be self-prescribed or used without advice of a doctor.”
On the “Aniracetam” page of your website:
  • “Memory Enhancement”
  • “Another interesting action of Aniracetam is the observed anxiety reducing effects.”
  • “Currently, it is approved for general memory and attention disorders and is commonly given to the elderly to help reduce symptoms of degenerative cognitive disorders.”
On the “Bacopa Monnieri” page of your website:
  • “…used to treat stomach disorders”
  • “…use to…stave off illnesses such as Alzheimer’s”
  • “…helps in protecting infants against neonatal hypoglycemia also known as low sugar”
  • “…reduces the risk of hypoglycemia in infants”
  • “…used to control blood pressure”
On the “L-Dopa” page of your website:
  • “L-Dopa is often recommended for Parkinson’s patients, as it helps in controlling involuntary movement generated in the skeletal muscles.”
  • “[L-Dopa] is known to reduce the effects of Parkinson’s disease…. Although you might not be able to see a radical difference within a short period of time, you will be able to avail positive benefits over a course of time.” 
On the “L-Theanine” page of your website:
  • “…it could be a vital component in the treatment of Alzheimer’s disease.”
  • “…it could be an aid in combating schizophrenia or schizoaffective disorder.”
  • “…L-Theanine could be useful in the prevention of ischemic neuronal damage that may occur due to stroke.”
  • “…could be used in…lowering of lipids within the bloodstream and fighting obesity.”
On the “Noopept” page of your website:
  • “Noopept is being investigated as a possible treatment for Alzheimer’s.”
  • “Some doctors also prescribe [Noopept] to aid in the reduction of symptoms in patients with neurological diseases.” 
On the “Oxiracetam” page of your website:
  • “[Oxiracetam] has been cited in the medicine field as having benefits such as, increasing cognitive function and processing.”
  • “Overall, [Oxiracetam] improves cognition and memory and may provide an increase in sensory perception or reflexes in some users.”
On the “Phenibut” page of your website:
  • “The benefits claimed by many [from Phenibut] often relate to … a reduction in anxiety.”
On the “Phenylpiracetam” page of your website:
  • “Phenylpiracetam may be an alternative for those with ADHD not wanting to resort to typical ADHD medications.”
  • “Phenylpiracetam also increases the level of dopamine and noradrenaline in the   brain which may explain its’ [sic] stimulating and mood elevating properties.”
  • “POTENTIAL PHENYLPIRACETAM BENEFITS”
o   “Helps consolidate memory”
o   “Enhances Alertness & Focus”
 
On the “Piracetam” page of your website:
  • “[Piracetam’s] primary medical use is as a neuro-protective agent before or after stroke. The substance is believed to reduce the risk of ischemic stroke as well as minimize post-stroke damages to the brain. It is also an anti-coagulant and anti-thrombotic agent which is often used safety [sic] in conjunction with other therapies.”
  • “For instance, there has been evidence in studies for effectiveness [of Piracetam] in improving symptoms in Alzheimer’s and Dementia patients.”
  • “[Piracetam] has been observed to be effective in increasing: cognition and memory, learning, focus and reaction times but these results seem to vary.” 
On the “Pramiracetam” page of your website:
  • “POTENTIAL PRAMIRACETAM BENEFITS”
    • “COMMONLY CLAIMED BENEFITS”
      • “Overall Improved Cognition.”
      • “Higher Sensory Perception.”
      • “Improved Working/Long-Term Memory.”
 
On the “Rhodiola Rosea” page of your website:
  • “…Rhodiola is said to increase the release of dopamine, which makes it an ideal drug to induce a natural high.”
  • “Rhodiola supplements are supposed to help in the reduction of cancer cells. Early studies on the drug claim that it is a good supplement to consider for reducing the risk of developing bladder cancer.”
  • “Those that suffer from high cholesterol can consider consuming this natural herb to reduce the risk of developing heart ailments. This chemical helps in reducing the bad cholesterol...”
On the “Uridine” page of your website:
  • “Uridine helps…prevent[] the onset of diseases like Alzheimer’s or Dementia.”
  • “One of the most significant effects of the drug is to enhance cognition. It assists in increasing a person’s cognitive behavior. If the person has undergone some brain trauma, then the drug can be used to reverse said trauma to a certain extent…”
  • “Uridine is used to reduce internal inflammation…”
  • “… the drug [Uridine] is said to reverse heart ailments…”
  • “Uridine triphosphate is said to reduce the risk of heart attack...”
  • “The drug [Uridine] is said to be effective in reversing osteoporosis…”
  • “Uridine is used to treat fibrosis…”
Your products Adrafinil, Aniracetam, Bacopa Monnieri, L-Dopa, L-Theanine, Noopept, Oxiracetam, Phenibut, Phenylpiracetam, Piracetam, Pramiracetam, Rhodiola Rosea, and Uridine are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” 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 the 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 C.F.R. § 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 products Adrafinil, Aniracetam, Bacopa Monnieri, L-Dopa, L-Theanine, Noopept, Phenylpiracetam, Piracetam, Rhodiola Rosea, and Uridine are 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 products safely for their intended purposes. Accordingly, Adrafinil, Aniracetam, Bacopa Monnieri, L-Dopa, L-Theanine, Noopept, Phenylpiracetam, Piracetam, Rhodiola Rosea, and Uridine fail to bear adequate directions for their intended uses and, therefore, the products are 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 these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive list 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 all products marketed by your firm comply with the Act and its implementing regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to 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 violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. 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.
 
Your written reply should be directed to Shawn Goldman, United States 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, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov.
 
Sincerely,
/S/
William A Correll, Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition 
 
 
 
CC:     Mr. Greg Wilburn
Inspection Unit Manager
Food and Drug Inspections Branch
1100 West 49th Street
Austin, Texas 78756


[1] We note that your Piracetam product is not labeled as a dietary supplement. Therefore, this letter does not address the issue of whether products containing piracetam can be lawfully marketed as dietary supplements.
[2] The definition of “drug” in section 201(g)(1)(C) of the Act contains an exception for foods, which affect the structure and function of the body by virtue of providing nutrition to sustain life and health.  The definition of drug in section 201(g)(1) also explicitly excepts dietary supplements for which certain truthful and not misleading statements about the effect of the product on the structure or function of the body are made, in accordance with section 403(r)(6) of the Act. Your Adrafinil, Aniracetam, Noopept, Oxiracetam, Phenibut, Phenylpiracetam, Piracetam, and Pramiracetam are not dietary supplements or conventional foods and do not qualify for this exception from the definition of “drug” in section 201(g)(1)(C) of the Act.   

 

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