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FDA Warning Letter Explorer
FDA warning letter · Drugs

Proper Nutrition Inc.

Issued · Posted by FDA

FDA published a close-out letter on Nov 10, 2021. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your Colostrum 70/40, Intestive, Seacure (blister pack and bottle), and SeaVive for Immune Support supplement products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act

Passage 2

Your Seacure (blister pack and bottle) and SeaVive for Immune Support supplement products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. 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

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.5