June 25, 2014
As the number of people diagnosed with diabetes continues to grow, illegally sold products promising to prevent, treat, and even cure diabetes are flooding the marketplace.
The Food and Drug Administration (FDA) is advising consumers not to use such products. They may contain harmful ingredients or may be otherwise unsafe, or may improperly be marketed as over-the-counter (OTC) products when they should be marketed as prescription products. They carry an additional risk if they cause consumers to delay or discontinue effective treatments for diabetes. Without proper disease management, people with diabetes are at a greater risk for developing serious health complications.
“People with chronic or incurable diseases may feel desperate and become easy prey. 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,” said Gary Coody, R.Ph., national health fraud coordinator for FDA. “Failure to follow well-established treatment plans can lead to, among other things, amputations, kidney disease, blindness and death.”
Recently, FDA launched an initiative to counter these illegally sold products aimed at consumers who have diabetes. In addition to evaluating numerous consumer complaints, FDA surveyed the marketplace for illegally sold products promising to treat diabetes and its complications.
In July 2013, FDA issued letters warning 15 companies about selling products for diabetes in violation of federal law. These products are sold as dietary supplements; alternative medicines, such as ayurvedics; prescription drugs and over-the-counter drugs, including homeopathic products: Examples of claims observed on these illegally marketed products include:
- “Lower your blood sugar naturally.”
- “Lowers A1C levels significantly.”
- “You’ll lower your chances of having eye disease, kidney disease, nerve damage and heart disease!”
- “It can replace medicine in the treatment of diabetes.”
- “For Relief of Diabetic Foot Pain.”
Some of the companies also promote unapproved products for other serious diseases, including cancer, sexually transmitted diseases, and macular degeneration.
FDA tested products marketed as “all natural” treatments for diabetes and discovered some of them contained one or more active ingredients found in prescription drugs to treat type 2 diabetes.
Undeclared ingredients can cause serious harm. If consumers and their health care professionals are unaware of the actual ingredients in the products they are taking, these products may interact in dangerous ways with other medications. One possible complication: Patients may end up taking a larger combined dose of the diabetic drugs than they intended, and that may cause a significant unsafe drop in blood sugar levels, a condition known as hypoglycemia.
FDA also looked at sales of prescription drugs from fraudulent online pharmacies. Signs that indicate an online pharmacy is legitimate include: requiring that patients have a valid prescription; providing a physical address in the U.S.; being licensed by a state pharmacy board; and having a state-licensed pharmacist to answer questions. Some fraudulent online pharmacies illegally sell drugs that are not approved in the United States, or sell prescription drug products without meeting necessary requirements.
One website that is subject to a warning letter shipped a prescription diabetes drug without requiring a prescription, and even included an unsolicited free sample of a prescription drug for erectile dysfunction. Moreover, the prescription diabetes drug was dispensed without the medication guide and other precautions required by FDA to ensure the drug is used safely and appropriately.
Although some of these websites may offer for sale what appear to be FDA-approved prescription drugs, FDA cannot confirm that the manufacture or the handling of these drugs follows U.S. regulations or that the drugs are safe and effective for their intended uses. Also, there is a risk the drugs may be counterfeit, contaminated, expired or otherwise unsafe.
June 15, 2014
One of the greatest benefits of losing weight is gaining a higher level of energy. When you lose weight, the body does not have to work as hard to maintain basic functions, freeing up that energy for other activities. There are a few factors to consider when losing weight to gain energy.
The metabolic rate governs the speed at which the body breaks down food, absorbs nutrients and eliminates waste. This plays a key role in weight loss and has a lot to do with daily natural energy levels. In order to keep a healthy metabolic rate, the digestive system, the nervous system and the circulatory system must be healthy and strong.
June 4, 2014
The Food and Drug Administration (FDA) is proposing two rules that represent a fundamental shift in its oversight of imported foods. The shift is designed to help prevent safety problems before those foods arrive in the United States, rather than having to rely primarily on inspections at U.S. ports of entry.
The proposed Foreign Supplier Verification and Accredited Third Party Certification rules are the next major steps in implementing the FDA Food Safety Modernization Act signed by President Obama in 2011. The law calls for science-based changes to the food safety system to prevent foodborne illnesses.
The new rules would make importers more accountable for food safety, and would establish standards for third-party audits of foreign food producers. These proposals would strengthen FDA’s ability to monitor those facilities and respond if there are unsafe practices. A lot of the food we eat is imported—15 percent of the U.S. food supply, including nearly 50 percent of fresh fruit and 20 percent of fresh vegetables.
“We must work toward global solutions to food safety so that whether you serve your family food grown locally or imported you can be confident that it is safe,” says FDA Commissioner Margaret A. Hamburg, M.D.
The new rules would complement two others proposed in January 2013. The proposed Preventive Controls for Human Food rule would set safety requirements for facilities that process, package or store food for people. And the proposed Produce Safety rule would establish science-based standards for the safe growing, harvesting, packing, and holding of produce on farms.