Rico-Perez Products, Inc.

WARNING LETTER Rico-Perez Products, Inc. MARCS-CMS 547180 — May 18, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Reference #: 18-HFAE4-WL-03 Product: Drugs Food & Beverages Recipient: Recipient Name Carlos Rico Recipient Title Co-Owner and Manager Rico-Perez Products, Inc. 2295 Coral Way Coral Gables , FL 33145 United States Issuing Office: Center for Food Safety and Applied Nutrition Office of Human and Animal Food Operations East Division IV 466 Avenida Fernandez Juncos San Juan , PR 00901 United States 787-729-8500 Dear Mr. Rico: This is to advise you that in March 2018, the United States Food and Drug Administration (FDA) reviewed your website at https://ricoperez.com from which you take orders for the products 70/20 Multi-Vita, Aloe Vera, Alpha Lipoic Acid, Amino Complex, Arth-Aid, B-Complex, Biotin, “Calcium, Magnesium & Zinc,” Cholesterine, Chromium Picolinate, CinSulin, Circu-Vite, Co-Q10, Colostrum, Cranberry, EPA-Fish Oil, Garlic Oil, Herbal Calm, Immune Complex, Milk Thistle, Pino-Rico, Psyllium (Organic), Rico Alerta, Rico-Amor, Rico Blood, Selenium, Shark Cartilage, St. Johns Wort, Sueno Forte, Super Energy, Thermo X Energy, Triple Lecithin, Vinpocetine, Vitamin D, Vitamin E, Women’s Balance, and Zinc. The claims on your website and product labeling 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 may find the Act and FDA regulations through links in 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: Chromium Picolinate: “Also recommended for people who suffer from ulcers or gastritis.” Pino-Rico: “Pino-Rico is a powerful . . . natural anti-inflammatory . . . recommended for . . . diabetes health, mentrual [sic] disorders, asthma, and allergies.” Rico-Amor: “Recommended . . . for men with erectile disfunction [sic]” The website also lists products by groups. These groups have titles that establish that the products listed in the groups are intended for use in the cure, mitigation, treatment, or prevention of disease, such as: Allergies group: Immune Complex, Alpha Lipoic Acid, CinSulin, Pino-Rico, EPA-Fish Oil, Milk Thistle, Colostrum, B-Complex, Vitamin D. Anemia and blood group: Rico Blood, 70/20, Super Energy, Alpha Lipoic Acid, BComplex, Amino Complex, Colostrum, EPA-Fish Oil, Vitamin D. Arthritis group: Arth-Aid, Co-Q10, Shark Cartilage, “Calcium, Magnesium & Zinc,” EPA Fish Oil, Colostrum, Alpha Lipoic Acid, CinSulin, Pinos-Rico, Garlic Oil, B-Complex, Vitamin D. Blood pressure group: Garlic Oil, Cranberry, Co-Q10, EPA–Fish Oil. Cancer and Tumors group: Shark Cartilage, Vitamin E, Selenium, “Calcium, Magnesium & Zinc,” Colostrum, Alpha Lipoid Acid, Co-Q10, B-Complex, Vitamin D, EPA-Fish Oil. Cholesterol group: Cholesterine, Triple Lecithin, Psyllium (Organic), Garlic Oil. Diabetes group: Chromium Picolinate, Circu-Vite, Zinc, Co-Q10. Migraine group: Vinpocetine, Aloe Vera, Herbal Calm, B-Complex, Colostrum, Alpha Lipoic Acid, Co-Q10, Psyllium (Organic), EPA-Fish Oil, Rico Alerta, Vitamin D, Milk Thistle. Nerves and depression group: Herbal Calm, B-Complex, Zinc, St. Johns Wort, Rico Alerta, Thermo X Energy, Alpha Lipoic Acid, Vinpocetine, Triple Lecithin, EPA-Fish Oil, Biotin, Colostrum, Vitamin D. Osteoporosis group: “Calcium, Magnesium, & Zinc,” Shark Cartilage, B-Complex, Thermo X Energy, Sueno Forte, Alpha Lipoic Acid, EPA-Fish Oil, Women’s Balance, Colostrum, Vitamin D. The aforementioned 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), 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 products Alpha Lipoic Acid, B-Complex, Biotin, “Calcium, Magnesium & Zinc,” Chromium Picolinate, Circu-Vite, Co-Q10, Colostrum, Cranberry, EPA-Fish Oil, Garlic Oil, Herbal Calm, Pino-Rico, Rico Alerta, Rico-Amor, Selenium, Shark Cartilage, St. Johns Wort, Thermo X Energy, Triple Lecithin, Vinpocetine, Vitamin D, Vitamin E, and Zinc 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, these products 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 statement of violations that exist in connection with your products. It is your responsibility to ensure your establishment is in compliance with the Act and its implementing regulations. You should take prompt measures to correct all violations described in this letter. Failure to do so may result in enforcement action by FDA without further notice, such as injunction or seizure. Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these violations. You may wish to include in your response documentation such as labels, and photographs of corrections your firm has taken or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) days, please provide the reason for the delay and provide a timeline for correcting these violations. Your reply should be directed to Mr. Miguel Hernandez, Acting District Director, Food and Drug Administration, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact Ms. Pearl Gonzalez, Compliance Officer, at (407) 475-4730 or pearl.gonzalez@fda.hhs.gov . Sincerely yours, /S/ Miguel Hernandez-Sanchez Acting Director San Juan District and Acting Program Director of Office of Animal and Human Food Operations, East Division IV Content current as of: 05/29/2018 Regulated Product(s) Drugs Food & Beverages