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Sanguenol ED Supplement Alleged to Be Unapproved Drug Class Action

If a company claims that its supplements are for “the prevention, cure, mitigation, and therapeutic treatment of disease,” then they are considered to be drugs and must be regulated and approved by the Food and Drug Administration (FDA). The complaint for this class action alleges that North American Nutraceuticals, LLC has been selling “illegal, unapproved drugs” in the form of its supplement Sanguenol, which it advertises as helping with erectile dysfunction (ED).

The class for this action is all those nationwide who bought Sanguenol between January 8, 2017 and January 8, 2021.

The complaint describes Sanguenol as “a male sexual enhancement pill” and quotes its maker as saying it’s “the only thing that can increase erections.” It summarizes North American’s claims as “promis[ing] that Sanguenol will deliver rock hard erections that soar 500% among older men” and “initiat[ing] and sustain[ing] a strong erection of greater width, length and firmness” and “enhance[ing] sexual performance.”

Sanguenol supposedly contains a combination of amino acids and herbal material, which makes it meet the definition of a dietary supplement.

The complaint quotes the Code of Federal Regulations for a definition of disease: “damage to an organ, part, structure, or system of the body such that it does not function properly…” It further quotes the law as saying that a “statement claims to diagnose, mitigate, treat, cure, or prevent disease if it claims, explicitly or implicitly, that the product…” does any of a number of things. Among those things are the following:

“Has an effect on a specific disease or class of diseases;”

“Has an effect on the characteristic signs or symptoms of a specific disease or class of diseases, using scientific or lay terminology;” or

“Has an effect on an abnormal condition associated with a natural state or process, if the abnormal condition is uncommon or can cause significant or permanent harm.”

The complaint then alleges, “In interpreting [this part of the Code], the FDA has concluded and ruled that a claim that a dietary supplement can treat ED and/or that such product helps to induce or maintain an erection is a disease claim.”

Thus, it says, the claims North American makes for Sanguenol are disease claims and Sanguenol is an unapproved drug.

What is the legal upshot, then, in this particular case? The complaint alleges that the claims North American makes for Sanguenol “constitute material misstatements of fact under the New Jersey Consumer Fraud Act and are violative of federal law” because they make Sanguenol a drug that the FDA has not approved for its “purportedly intended purpose.”

According to the complaint, both selling the “unapproved drug” Sanguenol and claiming that it treats ED are unlawful practices.

Article Type: Lawsuit
Topic: Consumer

Most Recent Case Event

Sanguenol ED Supplement Alleged to Be Unapproved Drug Class Action

January 8, 2021

If a company claims that its supplements are for “the prevention, cure, mitigation, and therapeutic treatment of disease,” then they are considered to be drugs and must be regulated and approved by the Food and Drug Administration (FDA). The complaint for this class action alleges that North American Nutraceuticals, LLC has been selling “illegal, unapproved drugs” in the form of its supplement Sanguenol, which it advertises as helping with erectile dysfunction (ED).

Sanguenol ED Supplement Alleged to Be Unapproved Drug Class Action

Case Event History

Sanguenol ED Supplement Alleged to Be Unapproved Drug Class Action

January 8, 2021

If a company claims that its supplements are for “the prevention, cure, mitigation, and therapeutic treatment of disease,” then they are considered to be drugs and must be regulated and approved by the Food and Drug Administration (FDA). The complaint for this class action alleges that North American Nutraceuticals, LLC has been selling “illegal, unapproved drugs” in the form of its supplement Sanguenol, which it advertises as helping with erectile dysfunction (ED).

Sanguenol ED Supplement Alleged to Be Unapproved Drug Class Action
Tags: Pharmaceuticals, Unapproved Drugs