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Full Spectrum St. John’s Wort Extract Misbranding Class Action

What’s the difference between a supplement and a drug? The Food and Drug Administration (FDA) considers substances that are “intended for use in the cure, mitigation, treatment, or prevention of disease” to be drugs, which the FDA must review and approve before they can be introduced into interstate commerce. The complaint for this class action alleges that ProHealth, Inc.’s Full Spectrum St. John’s Wort Extract is being offered as a drug, and that ProHealth has already been sent a warning letter by the FDA.

The class for this action is all persons who bought the product between June 11, 2017 and the date of the class notice in this case. A California subclass has also been proposed for those who bought the product in California.

ProHealth advertises the product on its website with two claims, the complaint alleges: “Effective for mild to moderate depression” and “Reduces anxiety.” The product also has labeling that purport to give directions for its use.

However, on February 18, 2021, the FDA sent a warning letter to ProHealth, explaining that the product was misbranded under the federal Food, Drug, and Cosmetic Act (FDCA).

The complaint quotes the letter as saying, in part, “The claims on your website establish that your product is a drug under … the Federal Food, Drug, and Cosmetic Act … because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce violates the Act.”

The letter then quotes the depression and anxiety claims for the product and says, “Your Full Spectrum St. John’s Wort Extract product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a ‘new drug’…”

It also has another complaint: “A drug is misbranded … if the drug fails to bear adequate directions for its intended use(s).”

What’s the problem with the directions for use? The product “is intended for treatement 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 product safely for its intended purposes. Accordingly, your Full Spectrum St. John’s Wort Extract product fails to bear adequate directions for its intended use and, therefore, the product is misbranded…”

The complaint therefore alleges that the St. John’s Wort Extract is “a worthless, misbranded drug” because “the Product is a misbranded drug that is unlawful to sell…” The company’s advertising and labeling, the complaint claims, is therefore deceptive.

Article Type: Lawsuit
Topic: Consumer

Most Recent Case Event

Full Spectrum St. John’s Wort Extract Misbranding Complaint

June 11, 2021

What’s the difference between a supplement and a drug? The Food and Drug Administration (FDA) considers substances that are “intended for use in the cure, mitigation, treatment, or prevention of disease” to be drugs, which the FDA must review and approve before they can be introduced into interstate commerce. The complaint for this class action alleges that ProHealth, Inc.’s Full Spectrum St. John’s Wort Extract is being offered as a drug, and that ProHealth has already been sent a warning letter by the FDA.

Full Spectrum St. John’s Wort Extract Misbranding Complaint

Case Event History

Full Spectrum St. John’s Wort Extract Misbranding Complaint

June 11, 2021

What’s the difference between a supplement and a drug? The Food and Drug Administration (FDA) considers substances that are “intended for use in the cure, mitigation, treatment, or prevention of disease” to be drugs, which the FDA must review and approve before they can be introduced into interstate commerce. The complaint for this class action alleges that ProHealth, Inc.’s Full Spectrum St. John’s Wort Extract is being offered as a drug, and that ProHealth has already been sent a warning letter by the FDA.

Full Spectrum St. John’s Wort Extract Misbranding Complaint
Tags: Deceptive Advertising, Deceptive Labels, Misbranding