Amerigo Labs LLC

WARNING LETTER Amerigo Labs LLC MARCS-CMS 543052 — April 04, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Mr. Ralph W. Maser/Mrs. Carol J. Maser Amerigo Labs LLC 9900 Pflumm Street, Suite #32 Lenexa , KS 66215 United States Issuing Office: Kansas City District Office United States Office of Human and Animal Foods – Division II West 8050 Marshall Drive - Suite 205 Lenexa, Kansas 66214-1524 913-495-5100 April 4, 2018 WARNING LETTER VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED CMS Case # 543052 Mr. Ralph W. Maser, Owner Mrs. Carol J. Maser, Owner Amerigo Laboratories LLC 9900 Pflumm Street, Suite #32 Lenexa, KS 66215 Dear Mr. Maser and Mrs. Maser: On November 2, 2017 through November 13, 2017, investigators from the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 9900 Pflumm Street, Suite #32, Lenexa, KS 66215. After the close of the inspection, this is to advise you that FDA reviewed your website at the Internet address https://www.poweruppowerdown.com in March 2018 and has determined that you take orders there for the products PowerUp and PowerDown. The claims on your website establish that the products are drugs 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 they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further 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. New and Misbranded Drugs Examples of some of the website claims that provide evidence that your products are intended for use as drugs include: From the articles listed on the “Insights” page within https://www.poweruppowerdown.com/blogs/news a. “5 Tips for Living with Narcolepsy from Biochemist and Brain Function Expert Ralph Maser …” 1. ‘“The idea that we can decrease the symptoms of narcolepsy and improve overall brain function at the same time, that’s what we believe in with PowerUp | PowerDown’ said co-creator Carol Maser…” 2. “The supplements are not just for people who suffer from narcolepsy. ‘PowerUp | PowerDown …” b. “Help and Hope for People with Narcolepsy and Cataplexy …”: 1. “Both medications and supplements have proven to be effective for some people with narcolepsy and cataplexy. The PowerUP | PowerDOWN system has been shown to help regulate the symptoms that come with EDS....” c. “Could Your Parenting Struggles Be Signs of ADHD …” 1. “If you have many of the above symptoms and would like to try a nonmedical intervention, PowerUp | PowerDown has been shown to be effective in adults with ADHD...” d. “Non-prescription Alternatives for Adults with ADHD …”’ e. “5 Effective Strategies for Managing ADHD from Brain Function Expert and Biomedical Engineer Ralph Maser …” From the articles listed on the “Ingredients” page within “What’s in PowerUp?” https://www.poweruppowerdown.com/pages/whats-in-powerup i. “Alpha-GPC (Alpha-Glyceryl Phosphoryl Choline) is considered to be one of the most effective brain nutrients in the world, and is used widely in clinical settings around the world involving memory loss, cognitive dysfunctions, and dementias of various kinds...” ii. “Siberian ginseng…also been known to have properties to cure other ailments. With effects on the adrenal glands, the benefits of Siberian ginseng include: prevention of illnesses caused by stress…relief of chronic fatigue syndrome symptoms, and increased immune system function...” iii. “Ginkgo is most commonly used to…stop tinnitus (ear-ringing) through its effects on the vascular system...” iv. “Ginkgo reduces the platelet activity factor (PAF) in the blood, similar to the action of aspirin on blood thinning...” v. “Clinical trials have been promising to test the effectiveness of ginkgo biloba as a medicinal herb for treating Alzheimer’s disease…” vi. Under ingredient, glycine: “Major contributor in improving symptoms of memory loss, schizophrenia, Parkinson’s disease, Huntington’s disease...” Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 335(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 PowerUp and PowerDown products 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, your products fail to bear adequate directions for their intended use and, therefore, these 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)]. Misbranded Dietary Supplements Even if your products did not have therapeutic claims which make them unapproved new drugs, your products are misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101. 1. Your PowerUp and PowerDown products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36. 2. Your PowerUp and PowerDown products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the products’ labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. 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 assure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. We offer the following comments: 1. Your PowerDown Supplement Facts labeling shown on your products’ promotional brochures and website fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 2. The Supplement Facts labeling shown on your products’ promotional brochures and website do not present nutrition information in accordance with 21 CFR 101.36. For example: Your PowerUp and PowerDown Supplement Facts labeling declare 20 and 15 calories, respectively, but they do not declare the macronutrient(s) that contribute to those calories (e.g., total carbohydrates and sugars). Your PowerUp Supplement Facts labeling declares the dietary ingredient vitamin B3, but this is not the nomenclature or synonym specified for niacin in 21 CFR 101.9 or 101.36(b)(2)(i)(B). Your PowerDown Supplement Facts labeling declares the dietary ingredient vitamin B9, but this is not the nomenclature or synonym specified for folate. Your PowerDown Supplement Facts labeling declares vitamin B1. While this alternative name is an acceptable synonym for thiamin in accordance with 21 CFR 101.9(c)(8)(v), the synonym should parenthetically follow the name of the nutrient. Furthermore, the labeling fails to declare the quantitative amount of thiamin using the correct unit of measure given in 21 CFR 101.9(c)(8)(iv) in accordance with 21 CFR 101.36(b)(2)(ii)(B). Your PowerUp Supplement Facts labeling bears an incorrect %DV for niacin, vitamin B6, and vitamin E based on the quantitative amounts declared per serving. Your PowerDown Supplement Facts labeling bears an incorrect %DV for thiamin, vitamin B6, and vitamin E based on the quantitative amounts declared per serving. Your PowerUp Supplement Facts labeling declares Optiberry as a proprietary blend but fails to list the dietary ingredients in accordance with 21 CFR 101.36(c)(2). Your PowerUp and PowerDown Supplement Facts labeling declare a serving size of 1.85 fl oz, but this amount is greater than the 1.8 fl oz net quantity of contents listed on the labeling. 3. The term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, the promotional brochure for your PowerUp product and your website ingredient pages for your PowerUp and PowerDown products declare a dietary ingredient identified as eleuthero root (Siberian ginseng). That ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax. Within fifteen (15) working days of the receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that corrective action has been achieved. If you cannot complete all corrections within fifteen (15) working days, you should explain the reason for your delay and the time within which the remaining corrections will be completed. Address your reply to the U.S. Food and Drug Administration; Attn: Victoria A. Wagoner, Compliance Officer, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions regarding any issue in this letter, please contact Victoria Wagoner, Compliance Officer at (913) 495-5150 or Victoria.Wagoner@fda.hhs.gov . Sincerely, /S/ Cheryl A. Bigham Program Division Director Office of Human and Animal Foods – Division II West Content current as of: 04/17/2018