Bodyhealth.com, LLC

WARNING LETTER Bodyhealth.com, LLC MARCS-CMS 610728 — December 09, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Product: Drugs Food & Beverages Recipient: Recipient Name Mr. David Minkoff Recipient Title Registered Agent Bodyhealth.com, LLC 707 Cleveland St. Clearwater , FL 33755-4107 United States Issuing Office: Division of Human and Animal Food Operations East IV United States WARNING LETTER 21-HAFE4-WL-01/CMS No. 610728 Dear Mr. Minkoff: This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.bodyhealth.com in December 2020 and has determined that you take orders there for the products “Healthy-Thin Energize,” “Body Detox (Oral Spray),” and “Omega 3 Health”. The claims on your website establish that these 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. Examples of some of the website claims that provide evidence that your products are intended for use as drugs include: 1. Product: “Healthy-Thin Energize” On the image of your product label shown on your product page https://bodyhealth.com/products/healthy-thin: “Supports Blood Sugar Levels*” On your product page under “Description”: • “This ayurvedic herb has been used for thousands of years to treat diabetes and other metabolic conditions.” • “Momordica charantia…It lowers blood sugar and cholesterol, improves glucose regulation…” 2. Product: “Body Detox (Oral Spray)” On the image of your product label shown on your product page https://bodyhealth.com/products/body-detox: • “Body detox gives a necessary boost to your body’s natural detox pathways along with some extra help for removing heavy metals, viral particles, and other harmful chemicals…” On your product page, under “Description”: • “[S]aving your kidneys from the damage and overwork common in many detox programs…” • “… or simple daily use as a prophylactic - stopping the toxins before they ever have a chance to build up in the first place.” On your product page, under “Ingredients”: • “Protease inhibitors- are a class of compounds used to treat or prevent infection by viruses, including HIV and Hepatitis C.” 3. Product: “Omega 3 Health TM ” On the image of your product label shown on your product page https://bodyhealth.com/products/omega-3-health: • “Inflam-ArrestTM helps support a healthy response to inflammation, which studies have shown to be the root cause of many health conditions.” On your product page under “Description”: • “Studies have shown that Omega-3 supplements improve focus, concentration, and lower symptoms of ADD.” • “Other studies have found that Omega-3 supplementation reduced symptoms of depression by 40%, and even impacts other forms of anxiety and mood disorders.” • “Still other studies show that Omega-3s alleviate with the debilitating, degenerative effects of dementia.” On your product page under “Ingredients & Benefits”: • “…Omega-3 Health has been specifically designed to help manage inflammation.” • “Chronic inflammation is at the root of dozens of diseases. And those are just the ones we know of.” • “Rheumatoid Arthritis. IBS, Ulcers, and other digestive issues. Autoimmune disorders. Degenerative brain conditions like Alzheimer’s and Parkinson’s, just to name a few of the most prominent ones. In all of these conditions, a uniting theme in their etiology is chronic inflammation leading to extensive oxidative damage that ultimately destroys tissues and creates symptoms.” Your products “Healthy-Thin Energize,” “Body Detox (Oral Spray),” and “Omega 3 Health” 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 “Healthy-Thin Energize,” “Body Detox (Oral Spray),” and “Omega 3 Health” 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, “Healthy-Thin Energize,” “Body Detox (Oral Spray),” and “Omega 3 Health” fail to bear adequate directions for their intended uses 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 in connection with your marketed 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 federal law, including 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. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Your written response should be directed to the U.S. Food and Drug Administration, attention to: Mr. Ramon A. Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact, Ms. Marilyn Santiago, Compliance Officer, at (787) 729-8707 or via email at Marilyn.santiago@fda.hhs.gov. Sincerely, /S/ Ramon A. Hernandez District Director | FDA San Juan District Program Division Director Office of Human and Animal Food Operations- East Division 4 Content current as of: 01/19/2021 Regulated Product(s) Drugs Food & Beverages