FDA Cites Firms for Unapproved Diabetes Treatments; Warns Consumers


The Food and Drug Administration (FDA) is warning consumers to avoid unapproved drugs to treat diabetes and related symptoms and has ordered a halt to the sale of a score of diabetic treatment compounds.

The federal agency in July issued warning letters to 15 companies selling a total of 20 products that claim to alleviate, cure, or prevent diabetes and complications of the disease to stop selling the products.

“It’s a violation of the Food, Drugs, and Cosmetics Act because some of these products are illegally sold as ‘natural treatments for diabetes’ but they contain undeclared drug products that are actual active ingredients and can cause harm,” said Christopher Kelly, a spokesman for the FDA.

“These products are dietary supplements that simply make claims to cure diabetes in ways that dietary supplements can’t. We even have subscription drugs that are being sold through online pharmacies without a prescription- you always need a valid prescription.”

The FDA is telling consumers to steer clear of unapproved products with labels that claim to "lower your blood sugar naturally," decrease risk of kidney disease, or “replace medicine in the treatment of diabetes."

According to the Centers for Disease Control and Prevention, 8.3 percent of Americans, or 25.8 million people, are being treated for diabetes or related conditions as of 2011.

Diabetes and associated illnesses are the leading cause of kidney failure and blindness for many adults, according to the CDC.

Kelly, who’s been with the FDA for more than six years, told the AFRO that whether the products are bought online or over the counter- at the heart of the issue is safety.

“We find that consumers delay seeking proper medical treatment and that leads to an increased risk of developing more serious complications.”

In warning letters July 15, the companies were told to halt sales of the unapproved products and respond to the FDA within 15 days about how they will correct the violations or face further action by the FDA which could include “seizure, injunction, and or criminal prosecution.”

Included are Enhance Nutraceutical in Malaysia, which markets Diaberex online, and Chicago’s Health King Enterprises and Balanceuticals Group, Inc., which sells a “Sugar Balancer” that a representative said isn’t specifically for diabetes treatment.

Neuliven Health did not respond to requests for comment on their product, Glucocil, which is still listed for sale on the firm’s website, and representatives of Nature’s Health Supply, Inc. in Camarillo, Calif., sellers of Diabetes Daily Care, declined to comment.

While some companies are ignoring the warning letters, some are complying.

Omar Lalani, director of PharmaTerra, spoke with the AFRO about the Mercer Island, Wash.-company’s product, ProBeta, also being marketed, without FDA approval, to control diabetes.

“We pulled it as soon as we received the warning because we are being as cautious as we can,” said Lalani, who disagrees with the FDA’s claim and said that the product is safe for consumers.

“Our customers are shocked and saddened by this decision.”

Representatives of the Oklahoma City-based Anastasia Marie Laboratories, Inc. twice refused to comment on FDA assertions about Diapedic Foot and Leg Treatment, which allegedly “relieves neuropathy pain… invigorates circulation… and speeds wound healing.”

Though the product is listed as not approved for diabetes treatment by the FDA, it is still the subject of the most prominent advertisement on the first page of their website.

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FDA Cites Firms for Unapproved Diabetes Treatments; Warns Consumers

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