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FDA Warning Letter Explorer
FDA warning letter · Drugs

ProHealth Inc.

Issued · Posted by FDA

FDA published a close-out letter on Jul 21, 2021. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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)].

Passage 2

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)].

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.5