What happened
Original notice title
American Botanical Pharmacy MARCS-CMS 562180, October 30, 2018
From the archived source record
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). Accordingly, your Incurables Program and SuperFood Plus products 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)]. Misbranded Dietary Supplements Even if your website, www.herbdoc.com , and associated Facebook page did not contain claims that cause your SuperFood Plus product to be an unapproved new and misbranded drug, this product would still be a misbranded food under section 403 of the Act [21 U.S.C. § 343] in that the label for this product does not comply with the labeling requirements in 21 CFR 101, as follows: Your SuperFood Plus product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Your SuperFood Plus product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343 § 343(q)(5)(F)] in that the presentation of the nutrition information (“Supplement Facts”) on the label of your product does not comply with 21 CFR 101.36. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your 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. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- ab41aa90f027
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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