USA Labs AKA Power Source Distributors, Inc AKA USA Sport

WARNING LETTER USA Labs AKA Power Source Distributors, Inc AKA USA Sport MARCS-CMS 539715 — January 10, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Charles T. Stokes USA Labs AKA Power Source Distributors, Inc AKA USA Sport 1049 Westfield Road Dickson , TN 37055 United States Issuing Office: Cincinnati District Office United States Cincinnati District Office 6751 Steger Drive Cincinnati, OH 45237 Telephone: (513) 679-2700 FAX: (513) 679-2772 January 10, 2018 WARNING LETTER 539715 VIA UPS Overnight Delivery Charles T. Stokes USA Laboratories 1049 Westfield Road Dickson, TN 37055 Dear Mr. Stokes: This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.usalabs.com in December 2017 and has determined that you take orders there for your products Maximum Male, Beta 300 (Beta Prosturol), Chromium Max 1000, DHEA, Healthy Cold-X and Healthy Heart. The claims on your website establish that the products are drugs under section 201(g)(1)(B) of 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 . Examples of some of the website claims that provide evidence that your products are intended for use as drugs include: Maximum Male “[S]upport help with erectile dysfunction.” Beta 300 (Beta Prosturol) “Prostatitis, the acute inflammation of the prostate gland, can occur in men of any age.” “Benign hypertrophy of the prostate occurs in 33% of all men over 50.” “If left untreated, it can cause painful, difficult and very frequent urination, kidney damage, bladder infections, and impotence.” “Prostate cancer is the third most frequent form of cancer in men, after lung and colon cancer, and it is often terminal.” Chromium Max 1000 “Lack of insulin can lead to elevated blood cholesterol levels, arterial deposits of fats, decreased life span, infertility…USA Laboratories provides the highest quality and purest obtainable form of Chromium Picolinate 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 which is used as an insulin regulator.” DHEA “In a study of 242 men over the age of 50, researcher (b)(6) at the (b)(4) found that those with high levels of DHEA in their blood were only half as likely to die of heart disease as those with relatively little of the hormone.” “Even with people without heart disease, DHEA seems to protect against early death.” Healthy Cold-X “It increases the ability of white blood cells to surround and destroy bacterial and viral invaders in the body.” Healthy Heart “‘Pharmacist Recommended, CO-Q-10, Chitosan, Green Tea Extract and Much More…Co-Q-10's main claim to fame is relieving congestive heart failure.’” “‘[S]tudies show that it is also successful in treating other forms of cardiovascular problems: high blood pressure, arrhythmia (irregular heartbeats), angina (chest pain), and mitral valve prolapse.’” 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)(1) of the Act [21 U.S.C. 321(p)(1)]. 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 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 Maximum Male, Beta 300 (Beta Prosturol), Chromium Max 1000, DHEA, and Healthy Heart 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, Maximum Male, Beta 300 (Beta Prosturol), Chromium Max 1000, DHEA, and Healthy Heart fail to bear adequate directions for their intended use 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 at your facility or 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 your firm complies with all requirements of the Act and all implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action, such as seizure and injunction, without further notice. You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct these violations, including an explanation of each step taken to prevent these violations and copies of supporting documentation, such as evidence of your revised and corrected web pages. If you cannot complete corrective actions within fifteen (15) business days, state the reason for the delay and the date by which these activities will be completed. Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Stephen J. Rabe, Compliance Officer; 6751 Steger Drive, Cincinnati, OH 45237 or via email at Stephen.rabe@fda.hhs.gov . You may reach Mr. Rabe at 513-679-2700, extension 2163, if you have any questions about this matter. Sincerely, /S/ Steven B. Barber Director, Division V Office of Human and Animal Foods Operations - East Cc Charles T. Stokes USA Laboratories P.O. Box 158 Dickson, TN 37056 Content current as of: 01/23/2018