1st Phorm LLC

Selected passages from the FDA letter

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

Passage 1

The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Your Whole Heart Cardiovascular Health Formula and Full-Mega Omega-3 Fish Oil products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)].

Passage 3

Your Whole Heart Cardiovascular Health Formula and Full-Mega Omega-3 Fish Oil 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.

Passage 4

To the best of FDA's knowledge, there is no information demonstrating that hordenine was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered.

Passage 5

Moreover, based on our evaluation of the relevant safety evidence, there is no history of use or other evidence of safety establishing that hordenine will reasonably be expected to be safe when used as a dietary ingredient.