Global Biotechnologies supplements seized over unauthorized disease claims

By Elaine Watson

- Last updated on GMT

During a recent inspection, FDA officials claimed that Global Biotechnologies had “continued to make illegal claims that cause their products to be misbranded drugs”, despite receiving a warning letter from the FDA
During a recent inspection, FDA officials claimed that Global Biotechnologies had “continued to make illegal claims that cause their products to be misbranded drugs”, despite receiving a warning letter from the FDA

Related tags: Medicine, Insulin resistance

The Food and Drug Administration (FDA) has sent in US marshals to seize supplements manufactured by Portland, Maine-based Global Biotechnologies Inc after the firm ignored warnings that it was making unauthorized disease claims.

US marshals – at the request of the FDA –seized supplements including Glucanol, Healthy Trac, Immunol, and Lactopril from the firm on May 31 after securing a warrant from the US District Court for the District of Maine.

Misbranded drugs

According to the FDA, Global Biotechnologies was sent a warning letter in 2006 alleging it was making unauthorized drug claims about the above supplements by claiming that they could prevent, treat, or cure diseases.

In the letter, which you can read here​, the FDA said the “therapeutic claims in your products' labeling establish that these products are drugs​”.

For example, Healthy Trac was claimed to help “reduce cholesterol, serum glucose and serum insulin levels, important factors for diabetics”,​ while Immunol was described as a “disease fighting powehouse​” that "mediates activity of autoimmune diseases”.

Firm ignored warnings, says FDA

At that time, the company committed to removing the alleged drug claims from its website, promotional materials, and product labels, said the FDA.

However, during a recent inspection, officials found that the company had “continued to make illegal claims that cause their products to be misbranded drugs”, ​said the agency.

Armando Zamora, acting director, office of enforcement, in the FDA’s Office of Regulatory Affairs, said: “The public relies on the FDA to keep companies from claiming that their products improve medical conditions or diseases.

“Using these products in the mistaken belief that they will cure a disease – especially when they cannot do so – represents a danger to the public’s health.”

Global Biotechnologies was unavailable for comment as this article went to press, while the FDA did not respond to questions asking why it had taken so long from sending a warning letter in 2006 to taking action against the company.

Related topics: Regulation

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