Brian White  |  December 31, 2020

Category: Legal News

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A binder reading "erectile dysfunction" on the spine lies near pills, a syringe and a stethoscope - Primal Max Red

Manufacturers of the erectile dysfunction supplement Primal Max Red make unfounded promises of being able to treat ED, according to a class action lawsuit.

Named plaintiff Harold Hoffman of New Jersey argues Primal Force Inc. is essentially selling illegal drugs unapproved by the Food and Drug Administration (FDA).

Retailing at $134.95 for a three-month supply, Primal Max Red comes in a powder with “nitric oxide boosters” that “help get large amounts of blood flowing,” according to the company’s website. 

In his class action lawsuit, Hoffman points out language used to promote Primal Max Red on published marketing material, including: “Rejuvenate your potency and power as a man” and “works for as long as you want… without fizzling out – even for months, or even years, on end.”

Hoffman says these statements amount to so-called “disease claims,” something the FDA’s Dietary Supplement Health and Education Act prohibits.

“Primal Max Red, which is touted as a dietary supplement, has not been approved or cleared by the FDA as therapeutic and/or suitable for use in the mitigation, prevention, treatment, or cure of any disease,” Hoffman says. 

Primal Max Red

The class action lawsuit argues erectile dysfunction is a disease and any product promising to treat it must be considered a pharmaceutical.

The FDA regulation “specifies the types of descriptive claims that may lawfully be made (and those that are prohibited) with respect to the efficacy of dietary supplements,” he says in the complaint. 

Held to this standard, Hoffman says Primal Max Red should be considered a new drug and cannot be marketed before being approved by the FDA.

Even so, Hoffman claims “the concoction of botanicals in Primal Max Red can treat male potency problems and/or ED are bogus.”

Not only do the makers of Primal Red Max violate federal law, they are reportedly in violation of state law, as well. 

Hoffman points out that the supplement has not been submitted to the FDA for review and the claims have not been scrutinized by peer-reviewed medical science research. 

This lack of evidence supporting what Primal Max Red can do violates New Jersey’s consumer fraud laws, Hoffman says. He alleges the company engages in “unconscionable trade practice” by deceiving, misrepresenting and falsely promising the supplement can treat erectile dysfunction.

“The marketing and sale of misbranded, unapproved or uncleared products, such as Primal Max Red, to treat disease, is a potentially significant threat to the public health,” Hoffman claims in the class action lawsuit. 

The class action lawsuit, initially filed in Superior Court of New Jersey, has since been removed to federal court district court. 

Hoffman is seeking to form a Class of plaintiffs who’ve purchased Primal Max Red in the last six years. 

Formally, the class action lawsuit accuses Primal Force Inc. of five counts of violating the New Jersey Consumer Fraud Act. 

Have you purchased or know someone who has purchased Primal Max Red? Let us know what you think of the class action lawsuit claims in the comments below. 

Counsel representing the plaintiff in the Primal Max Red class action lawsuit is Scott Shaffer of Olshan Frome Wolosky LLP.

The Primal Max Red Class Action Lawsuit is Harold Hoffman, et al. v. Primal Force Inc., Case No. 2:20-cv-20600-MCA-MAH, in the U.S. District Court for the District of New Jersey. 

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14 thoughts onPrimal Max Red ED Supplement Doesn’t Work As Promised, Class Action Says

  1. John Williams says:

    I don’t know whether the product works or not, but, I do know the above article throws the FDA name around a lot as well as the term ” peer-reviewed medical science research”, after the last 2 1/2 years, neither of those have the slightest bit of credibility. I would not base my decision on anything associated with the FDA, they are a joke.

  2. MELODY COTTON says:

    Add me please

  3. Patricia Schmitt says:

    Add me, please.

  4. Dana says:

    Add me

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