ProHealth Inc.

WARNING LETTER ProHealth Inc. MARCS-CMS 612227 — February 18, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Overnight Delivery Product: Drugs Food & Beverages Recipient: Recipient Name Richard Carson ProHealth Inc. 555 Maple St Carpinteria , CA 93013 United States Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States RE: [CMS: 36TU 612227 U36T ] Dear Mr. Carson, This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address 36T www.prohealth.com 36T in December 2020 and has determined that you take orders there for your 41T Full Spectrum™ St. John's Wort Extract 41T product. The claims on your website establish that your product is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at 36T www.fda.gov 36T . Examples of some of the website claims that provide evidence that your “ 41T Full Spectrum™ St. John's Wort Extract” 41T is intended for use as a drug include: On the webpage for “Full Spectrum™ St. John's Wort Extract”: 41T "Effective for mild to moderate depression" 19T41T 41T "Reduces anxiety" 19T41T Your Full Spectrum™ St. John's Wort Extract product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, 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 C.F.R. § 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 Full Spectrum™ St. John's Wort Extract product is 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 product safely for its intended purposes. Accordingly, your Full Spectrum™ St. John's Wort Extract product fails to bear adequate directions for its intended use and, therefore, the product is 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 marketed products. You are responsible for investigating and determining the causes of any violations 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 address the violations cited in this letter.  Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps that you have taken to address these violations.  Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so. Your reply should be sent via e-mail to FDAAdvisory@fda.hhs.gov . Sincerely, /S/ William A. Correll Jr. Director Office of Compliance Center for Food Safety and Applied Nutrition Food and Drug Administration Content current as of: 02/19/2021 Regulated Product(s) Drugs Food & Beverages