What happened
Original notice title
TEK Naturals MARCS-CMS 565026, February 05, 2019
From the archived source record
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include the following: On the “BURN4HER INGREDIENTS” page of your www.burn4her.com website: •“BURN4HER’s™ INGREDIENTS” o “Green Tea Extract … Green Tea’s polyphenols are scientifically proven to … reduce a woman’s risk for heart disease.” o “Green Coffee Beans … use of chlorogenic acid from green coffee bean extracts as an important inhibitor of diet-related obesity and obesity-related metabolic syndrome … [and] promote significant weight loss in individuals who suffer from morbid obesity. 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, BURN4Her, BurnerTEK, Mind Ignite, TEK Male, and TestoTEK fail to bear adequate directions for their intended use 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 injunction. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations.
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
- 8f4240afbfe4
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 →