What happened
Original notice title
TaperAid MARCS-CMS 542770, January 11, 2018
From the archived source record
In addition, the Federal Trade Commission has reviewed your marketing claims for your “TaperAid” products for potential violations of Sections 5 and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52. 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, “TaperAid” and “TaperAid Complete” 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 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 legal action without further notice, including, without limitation, seizure and/or injunction. Violations of the FTC Act may result in legal action in the form of a Federal District Court Injunction or an Administrative Order and may require that you pay money back to consumers. With regard to the advertising claims discussed above, please notify Edward Glennon of the FTC via electronic mail at eglennon@ftc.gov , within fifteen working days of receipt of this letter, of the specific actions you have taken to address FTC’s concerns. With regard to the FDA-related violations described in this letter, please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct the violations noted above.
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
- ab10fad1e4b9
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.
Sources, dates, and coverage →