What happened
Original notice title
Gold Crown Natural Products MARCS-CMS 566223, February 05, 2019
From the archived source record
Melatonin supplements such as melatonin with valerian tablets prevent the death of neurons caused by beta proteins which is a toxic substance which accumulates in the brain of the patients with this disorder. Your cholesterol levels can be lowered with the help of Heart Supplements.” “The Heart Supplements can be used to control your blood pressure.” “Heart Supplements can also help mitigate blockages in the blood vessels . . ..” “If you want to avoid the risk of heart disease or even diabetes, then getting blood circulation supplements daily can lessen those risks.” “Also, if your family has a history of diabetes, then it is possible that you could have that predisposition. 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, New Ultra Colostrum, Melatonin with Valerian, Anamu & Llanten, and Circulation Max 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 statement 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. 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
- 4fd5f5e2f92d
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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