Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589575.htm
Timestamp: 2019-01-18 19:06:56
Document Index: 654097453

Matched Legal Cases: ['art 111', 'art 111', '§ 342', '§ 321', '§ 331', '§ 342', '§ 342']

BrainAlert, LLC 12/14/17
In reply, refer to: WL CMS 535653
Jared K. Lykken, Distributing Agent
3116 164th Street SW, Unit #1106
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.
“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.
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.
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 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.