What happened
Original notice title
Proper Nutrition Inc. MARCS-CMS 612435, April 20, 2021
From the archived source record
It occurs when the junctions between your intestines malfunction and allow unwanted – and potentially toxic – material into your blood steam [sic]. 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 Seacure (blister pack and bottle) and SeaVive supplement products 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)]. This letter is 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 any violations and for preventing their recurrence or the occurrence of other violations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
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
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- f3c0d0ba075f
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 →