Lawsuit Investigation: Are 5-HTP Products Unsafe Drugs Disguised as Supplements?

Attorneys working with ClassAction.org would like to speak to anyone who has purchased 5-HTP, a supplement that claims to help with mood and sleeplessness.

Though some manufacturers are selling 5-HTP products as dietary supplements – which are not regulated by the FDA – the attorneys have reason to believe that the chemical is more complex than people realize and should actually be classified as a drug that requires proper testing, warnings and directions for use.

The risks associated with 5-HTP’s potentially illegal marketing are at least twofold. For one, consumers may be taking a drug that ought to require a prescription without a doctor’s guidance on dosing, side effects, and interactions with other medications and supplements. Secondly the potentially serious side effects and withdrawals themselves are risks (detailed below), ones which consumers who see this as merely a harmless or gentle “supplement” may not anticipate or be able to treat on their own.

Could 5-HTP Be an Unsafe Drug?

Under the Federal Food, Drug, and Cosmetic Act (FDCA), products that are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” are classified as drugs and must receive approval from the U.S. Food and Drug Administration (FDA) before they can be legally sold in the United States.

5-hydroxytryptophan, or 5-HTP for short, is sold by some companies as a dietary supplement marketed as able to help support mood, improve sleeplessness, reduce stress, promote relaxation or even help with weight loss. These marketing claims could potentially imply that the products can be used to treat medical conditions such as depression, anxiety and insomnia, and in that case, 5-HTP may fall under the FDCA’s definition of a drug.

Because 5-HTP is marketed as a dietary supplement instead of a drug, it is not regulated by the FDA and has not been subject to the strict testing and labeling requirements that a new drug must meet before receiving FDA approval, such as an independent review to determine whether the product’s benefits outweigh its known risks or the placement of adequate warnings and directions for use on product labels.

Selling an unsafe drug that has not been properly approved is not only illegal, but could harm consumers who may have been misled about the product’s benefits and not warned about possible risks.

What Are the Risks of Taking 5-HTP?

5-HTP is a chemical precursor to serotonin – a neurotransmitter that plays a key role in regulating mood, among other functions – and can therefore be dangerous if taken with other medications and products that affect serotonin levels.

There have been several case reports of patients experiencing adverse health effects, such as serotonin syndrome, after taking 5-HTP along with some of the products mentioned above.

5-HTP also has some common side effects – including heartburn, stomach pain, nausea, vomiting, diarrhea, drowsiness, sexual problems and muscle problems – and when taken in large doses, can lead to severe stomach problems and muscle spasms. In some cases, these risks are not disclosed on product labels.

Consumers may also be misled into believing 5-HTP is a suitable alternative to seeking treatment from a professional for serious medical conditions or disorders. Though some preliminary studies suggest the chemical could potentially improve symptoms of certain conditions, medical experts agree that there hasn’t been enough research to determine the product’s safety and effectiveness.

How Could a Class Action Lawsuit Help?

A class action lawsuit could help buyers get back some of the money they spent on 5-HTP supplements. It could also possibly force the manufacturers to change how the products are marketed and remove any potentially misleading information.

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