- Delivery Method:
- Via Overnight Delivery
Food & Beverages
- ProHealth Inc.
555 Maple St
Carpinteria, CA 93013
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
Dear Mr. Carson,
This is to advise you that the Food and Drug Administration (FDA) reviewed your web site on the Internet cope with 36Twww.prohealth.com in December 2020 and has decided that you’re taking orders there on your 41TFull Spectrum™ St. John’s Wort Extract41T product. The claims to your web site determine that your product is a drug beneath segment 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] as a result of it’s supposed to be used within the treatment, mitigation, remedy, or prevention of illness. As defined additional under, introducing or handing over this product for advent into interstate trade violates the Act. You can in finding the Act and FDA rules via hyperlinks on FDA’s house web page at 36Twww.fda.gov.
Examples of one of the web site claims that supply proof that your “41TFull Spectrum™ St. John’s Wort Extract”41T is meant to be used as a drug come with:
On the webpage for “Full Spectrum™ St. John’s Wort Extract”:
- 41T“Effective for mild to moderate depression” 19T41T
- 41T“reduces nervousness”19T41T
Your Full Spectrum™ St. John’s Wort Extract product isn’t most often known as protected and efficient for the above referenced makes use of and, due to this fact, this product is a “new drug” beneath segment 201(p) of the Act [21 U.S.C. § 321(p)]. With positive exceptions now not acceptable right here, new medicine will not be legally offered or delivered for advent into interstate trade with out prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. The FDA approves a brand new drug at the foundation of clinical knowledge and data demonstrating that the drug is protected and efficient.
A drug is misbranded beneath segment 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to undergo good enough instructions for its supposed use(s). “Adequate directions for use” manner instructions beneath which a layperson can use a drug safely and for the needs for which it’s supposed (21 CFR § 201.5). Prescription medicine, as outlined in segment 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can handiest be used safely on the course, and beneath the supervision, of a certified practitioner.
Your Full Spectrum™ St. John’s Wort Extract product is meant for remedy of a number of sicknesses that don’t seem to be amenable to self-diagnosis or remedy with out the supervision of a certified practitioner. Therefore, it’s inconceivable to jot down good enough instructions for a layperson to make use of your product safely for its supposed functions. Accordingly, your Full Spectrum™ St. John’s Wort Extract product fails to undergo good enough instructions for its supposed use and, due to this fact, the product is misbranded beneath segment 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The advent or supply for advent into interstate trade of those misbranded medicine violates segment 301(a) of the Act [21 U.S.C. § 331(a)].
The violations cited on this letter don’t seem to be supposed to be an all-inclusive commentary of violations that exist in connection along with your advertised merchandise. You are answerable for investigating and figuring out the reasons of any violations and for fighting their recurrence or the incidence of alternative violations. It is your accountability to make sure that your company complies with all necessities of federal regulation, together with FDA rules.
You must take instructed motion to deal with the violations cited on this letter. Failure to promptly cope with those violations would possibly lead to criminal motion with out additional realize, together with, with out limitation, seizure and injunction.
Please notify FDA in writing, inside of fifteen operating days of receipt of this letter, of the particular steps that you’ve got taken to deal with those violations. Include a proof of every step being taken to forestall the recurrence of violations, in addition to copies of similar documentation. If you consider that your merchandise don’t seem to be in violation of the Act, come with your reasoning and any supporting data for our attention. If you can’t whole addressing those violations inside of fifteen operating days, state the cause of the lengthen and the time inside of which you’re going to achieve this. Your answer must be despatched by way of email to FDAAdvisory@fda.hhs.gov.
William A. Correll Jr.
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
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