Pharmaceutical

Dietary supplement maker warned about parasite infestation claims

fda logo Dietary supplement maker warned about parasite infestation claims Dietary supplement manufacturer Humaworm was hit with a Food and Drug Administration (FDA) warning letter for making claims that it’s products could cure, mitigate, treat or prevent diseases or conditions, a direct violation of the Federal Food, Drug and Cosmetic Act, the agency stated.

The warning comes following an agency inspection that occurred Aug. 16 and 17, 2016, and an agency review of the company’s website at www.humaworm.com in December 2016. The FDA said that the claims the company made regarding its products rendered them unapproved new drugs.

Some of the claims include statements such as “FACT: OVER 90% OF AMERICANS HAVE PARASITES,” “The Best Parasite Cleanse in the WORLD!” and “We will teach you about herbs that are used to safely eradicate all parasites from our human bodies.”

Under the “How We Get Parasites” tab, the company said that “parasite eggs are everywhere and are so easy to obtain,” and that consumers should “deworm YOURSELF and your family twice per year to stay clear of any parasitic infestations!”

Under the “Additional Cleansings Formula” tab, the company claimed that its NATURAL ANTI-BIOTIC formula helps to more naturally kill bacteria in the body, including the “lung bacteria that causes tuberculosis.” Its NATURAL ANTI-VIRAL formula was also touted to naturally kill a variety of viruses including the herpes simplex virus. The company was also pushing LYME’s & SYPHILLIS [sic] CLEANSING FORMULA.

The FDA’s lengthy warning letter also chided the company for its list of symptoms caused by parasite infestation and conditions that its products help to relieve.

“Your products “Humaworm Formula”, “Fast Help Formula”, “Liver & Gallbladder Cleanse & Restore”, “Lung Cleanser”, “Natural Anti-Biotic”, “Natural Anti-Viral”, “Herpes Cleansing Formula”, “Lyme’s & Syphillis Cleansing Formula”, “Hu-Mana-Tea!”, “Candida Yeast & Fungi Cleanse”, “Lung Cleanse”, “Herpes Formula Capsules”, “Lyme & Syphillis Cleanse Capsules”, “Herpes Formula Bulk”, “Lyme & Syphillis Cleanse Bulk”, “Hu-Mana-Tea Bulk”, “45 Day Organ Cleanse Package Capsules and Bulk” which includes the “Lung Cleanse” product, “Fast-Help Formula Capsules”, and “RG’s Medicated Cream” are intended for treatment of one or more diseases which 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 products safely for its intended purposes,” the FDA stated.

The company was advised to respond within 15 working days with any corrective actions it has taken or will take to prevent future violations.

Source: FDA Warning Letter