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WARNING LETTER

BrainAlert, LLC MARCS-CMS 535653 —

Recipient:
Recipient Name
Jared K. Lykken
BrainAlert, LLC

3116 164th Street SW, Unit #1106
Lynnwood, WA 98087
United States

Issuing Office:
Seattle District Office

United States

 

  

Black HHS-Blue FDA Logo

 

Seattle District Office
22215 261h Avenue SE, Suite 210
Bothell, Washington 98021
 

 
 

 

December 14, 2017                        
 
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply, refer to: WL CMS 535653
 
Jared K. Lykken, Distributing Agent
BrainAlert, LLC
3116 164th Street SW, Unit #1106
Lynnwood, Washington 98087
 
WARNING LETTER
 
Dear Mr. Lykken:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 3116 164th Street SW, Unit #1106, Lynnwood, Washington, June 19 and 20, 2017, and July 12, 2017. The inspection revealed serious violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your BrainAlert product to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that it has been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
 
In addition, FDA reviewed your website at www.brainalert.com. Based on our review, we have concluded that your BrainAlert product is an unapproved new drug and misbranded drug and that, even if it were not a drug, it would be a misbranded dietary supplement, as explained further below. You may find the Act and FDA regulations through links on the FDA’s home page at www.fda.gov.
 
Unapproved New Drugs/Misbranded Drugs
 
FDA reviewed your website www.brainalert.com in August 2017 and again in December 2017 and determined that you take orders there for your product BrainAlert. The claims on your website establish that the product is a drug under section 201(g)(1)(B) of 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.
 
Examples of some of the claims that provide evidence that your product is intended for use as drugs are listed below. This includes claims made about the ingredients present in BrainAlert (i.e., DMAE, Gotu Kola, huperzine A, and Vitamin B3 Niacinamide). 
  • “Are you struggling with … Seasonal depression? … Then BrainAlert is the solution for you!”
  • “DMAE was used to help ADD children in the 1980’s, which studies showing improvement in memory, concentration, and the ability to focus.”
  • “Traditionally, gotu kola has been used to treat anxiety …”
  • “Huperzine A … be more effective and selective than tacrine, a pharmaceutical drug, at inhibiting cholinesterase.”
  • “Vitamin B3 Niacinamide … Studies have shown niacinamide to product an anti-anxiety effect.”
In addition, when scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of citations as listed on your website used to market BrainAlert for disease treatment and prevention and are thus evidence of your product’s intended use as a drug: 
  • “Schonheit K, Gille L, Nohl H, Institute of Pharmacology and Toxicology, Veterinary University of Vienna, Austria. Effect of alpha-lipoic acid and dihydrolipoic acid on ischemia/reperfusion injury of the heart and heart mitochondria. Biochim Biophys Acta 1995 Jun 9;1271(2-3):335-42.”
  • “Salvioli G, Neri M. L-acetylcarnitine treatment of mental decline in the elderly. Drugs Exp Clin Res 1994;20(4):169-76.”
  • “Mortensen SA, Vadhanavikit S, Baandrup U, Folkers K. Long-term coenzyme Q10 therapy: a major advance in the management of resistant myocardial failure. Drug Exptl Clin Res 1985;11:581-93.”
  • “Soja AM, Mortensen SA. Treatment of chronic cardiac insufficiency with coenzyme Q10, results of meta-analysis in controlled clinical trials. Ugeskr Laeger 1997;159:7302”
  • “Shults CW, Oakes D, Kieburtz K, Beal F, Haas R, Plumb S, Juncos JL, Nutt J, Shoulson I, Carter J, Kompoliti K, Perlmutter JS, Reich S, Stern M, Watts RL, Kurlan R, Molho E, Harrison M, Lew M, and the Parkinson Study Group. "Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the functional decline." Archives of Neurology , October 2002, Vol. 59, No. 10, pp. 1541-1550.”
  • “Birks J, Grimley Evans J, Van Dongen M. Ginkgo Biloba for Cognitive Impairment and Dementia (Cochrane Review). In: The Cochrane Library, Issue 4, 2002. Oxford: Update Software”
  • “Ved HS, Koenig ML, Dave JR, et al. Huperzine A, a potential therapeutic agent for dementia, reduces neuronal cell death caused by glutamate. Neuroreport. 1997;8:963-968.”
  • “Gelenberg AJ, Gibson CJ, Wojcik JD. Neurotransmitter precursors for the treatment of depression. Psychopharmacol Bull 1982;18:7-18.”
  • “Yun TK, Choi SY. Non-organ specific cancer prevention of ginseng: a prospective study in Korea. Int J Epidemiol 1998;27:359-64.”
  • “Elliott RB, Pilcher CC, Fergusson DM, et al. A population based strategy to prevent insulin-dependent diabetes using nicotinamide. J Pediatr Endocrinol Metab. 1996;9:501-509.”
  • “Polo V, Saibene A, Pontiroli AE. Nicotinamide improves insulin secretion and metabolic control in lean type 2 diabetic patients with secondary failure to sulphonylureas. Acta Diabetol. 1998;35:61-64.”
  • “Jonas WB, Rapoza CP, Blair WF. The effect of niacinamide on osteoarthritis: a pilot study. Inflamm Res. 1996;45:330-334.”
  • “Anand JC. Osteoarthritis and pantothenic acid. Journal of the College of General Practice 5:136-7, 1963.”
  • “Malouf M, Grimley EJ, Areosa SA. Folic acid with or without vitamin B12 for cognition and dementia. Cochrane Database Syst Rev. 2003;(4):CD004514.”
Your product BrainAlert is not generally recognized as safe and effective for the above referenced uses and, therefore, 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) and 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate 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 product BrainAlert is intended for treatment of one or more diseases or conditions 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, BrainAlert 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)].
 
Adulterated Dietary Supplements 
 
Even if your product labeling did not contain claims that render the product an unapproved new drug and misbranded drug, your product BrainAlert would be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because it has been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. During the inspection, our investigator observed the following violations of the FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements:
 
1.    You failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55.  During our inspection, you informed our investigator that your firm receives finished, packaged, and labeled dietary supplements that your contract manufacturer manufactures, packages, and labels under your own firm’s name, and that you hold and distribute the dietary supplement. However, you have not established a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled according to established specifications. For example, you stated that you have no knowledge of how your contract manufacturer manufactures or handles your product prior to your receipt of the finished product, or whether your contract manufacturer conducts any testing of the product.
 
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm’s name,your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of the dietary supplement into interstate commerce in its final form for distribution to consumers.  As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements. 
 
Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements [see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act)].  In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)].  Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations. 
 
2.    Your firm failed to make and keep written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b).  Specifically, you have no written procedures for the responsibilities of the quality control operations.
 
To fulfill requirements for quality control operations, quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). Further, you must have documentation of the written procedures for the responsibilities of the quality control operations, including procedures for conducting a material review and making a disposition decision, and written documentation that quality control personnel performed review, approval, or rejection requirements, at the time of performance, for any packaged and labeled dietary supplement you distribute [21 CFR 111.127(h) and 111.140(b)]. 
 
3.    You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553.  Specifically, you have not established written procedures for handling product complaints.
 
Misbranded Dietary Supplement
 
Your BrainAlert product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient, i.e. Ginseng (Panax), Rhodiola rosea, Ginkgo Biloba, and Gotu Kola, in the product is derived, as required by 21 CFR 101.4(h)(1).
 
In accordance with 21 CFR 101.3(d), the statement of identity for a food in packaged form shall be presented in bold type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed.  The statement of identity of “DIETARY SUPPLEMENT” is not presented as such.
 
Your BrainAlert product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C.§ 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example,
  • Your BrainAlert product incorrectly lists in the Supplement Facts label thiamin and riboflavin in relation to the synonyms for these dietary ingredients. The synonyms should be placed in parentheses immediately following the name of the dietary ingredient per 21 CFR 101.9(c)(8)(v) and 21 CFR 101.36(b)(2).
  • Your BrainAlert product declares vitamin B3 which is not the nomenclature for niacin specified in 21 CFR 101.9 or 101.36(b)(2)(i)(B).
  • Your BrainAlert % Daily Value for thiamin HCl is incorrect. The % Daily Value should be rounded to the nearest whole percent per 21 CFR 101.36(b)(2)(iii)(C).  
Your website includes the statement, “Our product is made … in a FDA approved facility in the United States (USA) … ” FDA does not approve dietary supplement manufacturing facilities. Therefore, this statement is false or misleading and causes your dietary supplement product BrainAlert to be misbranded under section 403(a)(1) of the Act.
 
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. It is your responsibility to ensure that your products comply with all applicable statutes and regulations, including the Act and FDA’s implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, including, without limitation, seizure and injunction.
 
Please notify this office in writing within fifteen (15) business days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
 
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Please send your reply to the Food and Drug Administration, Seattle District Office, 22215 26th Avenue SE, Suite 210, Bothell, Washington, 98021, to the attention of Jessica L. Kocian, Compliance Officer. If you have any questions concerning this letter, you can contact Compliance Officer Jessica Kocian at (425) 302-0444.
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director
Program Division Director
 
 
cc: Washington State Department of Agriculture
      Food Safety Program
      P.O. Box 42560 
      Olympia, Washington 98504-2560
 

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