DMAA Supplements Are DONE: FDA Wins 11th Circuit Appeal

BREAKING (August 30, 2019): The United States 11th Circuit Court of Appeals has upheld the district court ruling, stating the following:

DMAA is not an “herb or other botanical.” It is not a “constituent” of an herb or other botanical. And it is not generally recognized by qualified experts, as adequately shown through scientific procedures, to be safe under the conditions of its intended use. The district court properly so ruled. The decision is AFFIRMED.

This page will be updated and news will be released shortly.

The official “conclusion” is on page 22 in the PDF linked above.

Jared Wheat Responds with Comment

No we are going to see an en banc rehearing as we believe Judge Jordan dissent was the correct interpretation. Judge Hinkle will not be part of an en banc ruling as he was sitting by designation due to the 11th circuit being short judges. There are 12 active judges and we will start 1 versus 1. Tjolflat is also retiring and may not be in the en banc decision as he is going to be 90 in December.

Eleventh Circuit rule:

11th Cir. R. 35-3 Extraordinary Nature of Petitions for En Banc Consideration. A petition for en banc consideration, whether upon initial hearing or rehearing, is an extraordinary procedure intended to bring to the attention of the entire court a precedent-setting error of exceptional importance in an appeal or other proceeding, and, with specific reference to a petition for en banc consideration upon rehearing, is intended to bring to the attention of the entire court a panel opinion that is allegedly in direct conflict with precedent of the Supreme Court or of this circuit. Alleged errors in a panel’s determination of state law, or in the facts of the case (including sufficiency of the evidence), or error asserted in the panel’s misapplication of correct precedent to the facts of the case, are matters for rehearing before the panel but not for en banc consideration

11th Cir. R. 35-2 Time – Extensions. A petition for en banc rehearing must be filed within 21 days of entry of judgment, except that a petition for en banc rehearing in a civil appeal in which the United States or an agency or officer thereof is a party must be filed within 45 days of entry of judgment. Judgment is entered on the opinion filing date. No additional time is allowed for mailing. Counsel should not request extensions of time except for the most compelling reasons. For purposes of this rule, a “civil appeal” is one that falls within the scope of 11th Cir. R. 42-2(a)

— Jared Wheat, CEO, Hi-Tech Pharmaceuticals

DMAA Banned

Unless taken to the Supreme Court, it seems like this one is over. DMAA is not a supplement, and as stated in the past, we will respect this court’s decision.

About the Author: Mike Roberto

Mike Roberto

Mike Roberto is a research scientist and water sports athlete who founded PricePlow. He is a biohacker with extensive experience in supplementation and dietary modification, whose personal expertise stems from several "n=1" experiments done on himself while sharing lab tests.

Mike's goal is to bridge the gap between nutritional research scientists and non-academics who seek to better their health in a system that has catastrophically failed the public.

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