FDA Cracks Down on Diabetes Marketing
The agency warns 15 companies about mislabeled or bogus products
Diexi. Diaberex. Glytain. Glucocil. Nepretin. They sound like medications your doctor might prescribe for treating diabetes. But they’re not. In July, the Food and Drug Administration (FDA) issued letters to 15 companies warning them that their mislabeled products were violating federal law. The FDA requested written responses within 15 days detailing how the companies would correct the violations. If they didn’t respond, the FDA had the right to take action, including seizure and criminal prosecution.
“Bogus products for diabetes are particularly troubling because there are effective options available to help manage this serious disease rather than exposing patients to unproven and risky products,” Gary Coody, RPh, national health fraud coordinator for the FDA, said in a statement. The FDA worries that failure to follow established treatment plans can lead to serious health problems and possibly death.
Some evidence suggests that cinnamon, capsaicin, and other substances may benefit people with diabetes, but labeling them as diabetes medications is illegal. The number of companies using diabetes-related marketing to sell their pills, tonics, and ointments has been on the rise. “We have received an increasing number of complaints about these products,” Coody told Diabetes Forecast. The complaints prompted the agency to conduct a targeted search for illegally marketed diabetes products. FDA investigators scanned the shelves of brick-and-mortar stores and checked cyberspace. Product claims made online are just as significant as those on a package, says Coody: “The website becomes part of the label.”
The FDA identified items it said were being sold illegally as dietary supplements; over-the-counter drugs, including homeopathic drugs; ayurvedics (preparations based on traditional, alternative-medicine practices from India); or products containing undisclosed prescription drugs. Each product category is regulated in a slightly different way, but in most cases the manufacturers ran afoul of the FDA by claiming a product could treat, cure, prevent, or mitigate diabetes or its complications.
Dietary supplements are limited, Coody says, to “structure-function claims,” based on a 1994 federal law that restricted the FDA’s oversight of supplement makers. For example, a supplement may be able to declare that it “supports healthy blood sugar” so long as it carries the FDA-required disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” Problems arise when a supplement comes with unproven medical claims. “You can take cinnamon and slap ‘diabetes’ on it, and you are selling a drug, not a spice,” says Coody. One offending product claimed it was an “effective treatment to relieve all symptoms of diabetes!” Sometimes the difference between legal and illegal statements can be subtle, says Coody, but not in these cases.
The FDA allows over-the-counter drugs, such as aspirin, to make specific statements about what they can do, such as reduce fever. Claims that can legally be made are spelled out in an FDA-approved document called the “drug monograph.” But if a marketer claims new powers for an over-the-counter drug, then the FDA can step in. The active ingredient in Zostrix Diabetic Foot Pain Relief Cream, one of the targeted products, is capsaicin, which the FDA classifies as a topical analgesic—a painkiller applied to the skin. Topical analgesics can legally claim to temporarily relieve minor aches and pains of muscles and joints. The Zostrix product, however, made additional, unproven claims related to diabetes. A product isn’t allowed to claim it treats a disease such as diabetes or its complications unless it proves itself to the FDA through rigorous clinical research, which Zostrix hasn’t done. That’s why the FDA put the manufacturer on notice.
A product labeled as homeopathic is, in the eyes of the FDA, a homeopathic drug, which is subject to its own set of regulations. The FDA recognizes a certain list of homeopathic ingredients, but the product cannot claim that it can treat a condition outside the specific confines of the approved medical uses listed for each homeopathic drug. Ayurvedic products are generally not reviewed or approved by the FDA and can’t make drug claims either.
If the offending claims are removed, mislabeled products could be sold legally. Three of the diabetes products targeted were deemed illegal because the FDA said they contained no-no ingredients: real prescription diabetes medications. While all the products on the FDA list could be dangerous—perhaps delaying people from seeking medical care and increasing their risk for complications—products containing unlisted pharmaceuticals, but often marketed as “natural” treatments for diabetes, pose the greatest threat. “The ones with hidden drugs could be a direct hazard,” Coody says. “Not only does the doctor not know [a patient is taking a particular drug], but the patient doesn’t know it.”
The FDA ordered a number of the diabetes products for laboratory testing. “We don’t have the resources to test everything that’s out there,” says Coody, but this was a special case. They found that Diexi, a product shipped from India, contained the drug metformin, and Insupro Forte, from Malaysia, contained glyburide. “They should require a prescription,” Coody says. “Yet they were sold over the counter.” In one case, the FDA issued a drug alert because it found metformin, glyburide, and phenformin in the Anti-Diabetic Pancreatic Capsule, shipped from China. Phenformin was removed from the U.S. market in 1978 for an association with lactic acidosis, which can cause weakness, nausea, and death in severe cases.
Was there enough of the medication in the products to do damage? “Two of them had what we consider fully therapeutic amounts,” says Coody. But, with such unregulated products, the dose can vary widely. “If one bottle has a small amount, the next could be huge,” he says.
In another example of what it called fraud, the FDA found websites selling diabetes medications without requiring a prescription and without the official labeling that contains critical product information. “Really use caution when you come across products like this,” Coody says. “These are drugs that are manufactured in a foreign country. … Many purport to be based in Canada, but they aren’t.” Coody says people should buy medications online only from sites licensed in the United States. And that’s only about 3 percent of all online pharmacies, according to the National Association of Boards of Pharmacy. For a list of safe pharmacies, visit www.fda.gov/BeSafeRx.
Many of the companies the FDA contacted have responded, according to Coody, and at press time some of the websites had removed the allegedly false claims or were “under construction.” “We are still in the process of talking with the firms,” he says. The agency did not hear from some of the international companies exporting products found to contain prescription drugs. The FDA put some of these products on import alert. “Our people will watch for those at the border,” says Coody. While the FDA made a thorough search for illegally marketed diabetes products, Coody says he’s certain there are still some out there. “The best thing you can do is to stay under the care of a health care provider,” he adds. Approved, legal medical therapies may not be miracle cures or inexpensive, “but they are the only proven ways [to treat diabetes],” Coody says. “There is no magic
Spotting False Claims
Unsafe products targeting people with diabetes are still on the market. Here are tips for steering clear of such items.
1. If it sounds too good to be true, it probably is.
You’ve heard this before, but it goes double for over-the-counter products that advertise or have packaging that claims they can treat, cure, or prevent diabetes or its complications.
2. Beware bogus online pharmacies.
A legitimate website will provide contact information, including a U.S. address, and ask for a prescription. If you buy online, purchase medications only from trusted providers on the list at www.fda.gov/BeSafeRx.
3. Tell your doctor everything.
Keep a list of all the supplements and over-the-counter medications you take and provide an updated list each time you visit your health care provider.
4. Don’t go “natural.”
A product sold as a “natural treatment for diabetes” should set off warning bells. These products may contain unlisted drugs.
5. No, they can’t replace your diabetes medications.
Avoid any over-the-counter products marketed as replacements for your prescription medications.
6. Be wary of creams.
Several topical painkillers claim to treat diabetic neuropathy (nerve damage, often with pain and/or lack of sensation). Don’t be fooled—these products may contain effective pain-relieving substances, but they haven’t met FDA standards for treating this diabetes complication.