U.S. Food and Drug Administration

The FDA has issued letters warning a number of domestic and international companies selling products claiming to treat, cure, prevent, or mitigate diabetes and related complications (e.g., blindness, nerve damage, kidney failure, heart disease, lower-extremity amputations, etc.) to consumers with diabetes in the United States. Companies are asked to provide a written response to address the violations covered in the letters. Companies that fail to respond to the warning letters or make adequate corrections could be subject to further actions, including seizure, injunction, and criminal prosecution.

Q1. What are the types of illegally sold diabetes products and where are they found? Q2. What are the products cited in FDA’s recent Warning Letters? Q3. Why should consumers be concerned about these products? Q4. What hidden active pharmaceutical ingredients (APIs) did the FDA find in the products? Q5. Is it safe to purchase diabetes prescription drugs from online pharmacies? Q6. What should consumers do to protect themselves from these products? Q7. Why is FDA acting now? Has any U.S. consumer been harmed by any of these products? Q8. How can I get more information about health fraud scams?

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Q1. What are the types of illegally sold diabetes products and where are they found?

A. The products are sold as dietary supplements; ayurvedics; over-the-counter (OTC) drugs, including homeopathic drugs; or unapproved prescription drugs. They can be found on the internet and in retail outlets.

Q2. What are the products cited in FDA’s recent letters?

A.The table below provides the names of companies and illegally sold products claiming to treat diabetes that have been cited in FDA’s recent letters. This is not an all-inclusive list of all the violative diabetes products currently on the market.

Q3. Why should consumers be concerned about these products?

A.Diabetes is a chronic disease requiring diagnosis and management under the supervision of a licensed health care provider. Not only can these illegally sold products be ineffective, they can cause consumers with diabetes to delay seeking proper timely treatment leading to an increased risk for developing serious health complications.

In addition, some of the products may cause harm because they contain undisclosed active pharmaceutical ingredients (also known as APIs), unknown harmful ingredients, may be contaminated, or may be of poor quality.

Products containing undisclosed APIs frequently claim to have similar therapeutic benefit and to be “all natural” or “chemical free” alternatives to available FDA-approved treatments. The FDA is unable to test and identify all products containing potentially harmful hidden ingredients sold to consumers on the internet and in retail stores. Therefore, consumers should exercise caution before using products claiming to be herbal or all-natural alternatives to FDA-approved prescription drugs. These products should be considered unsafe and should not be used.

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More information on how to reduce the risk of encountering a product with an undisclosed ingredient can be found on the FDA’s website at Medication Health Fraud.

Q4. What hidden active pharmaceutical ingredients (APIs) did the FDA find in the products?

A. FDA labs discovered various levels of hidden APIs in three tested products, including Diexi, Insupro Forte, and Jiang Tang Yi Huo Su Jiao Nang (translated: Anti-diabetic Pancreatic Capsule). These following ingredients were not declared on the product labels:

• Diexi contained the API metformin;
• Insupro Forte contained the API glyburide; and
• Anti-diabetic Pancreatic Capsule contained the APIs metformin, phenformin, and glyburide.

Metformin and glyburide are APIs found in FDA-approved drugs used to treat type 2 diabetes. Phenformin was removed from the U.S. market in 1978 because it was associated with lactic acidosis, a serious condition requiring immediate medical attention that is caused by a buildup of lactic acid in the blood, in patients with diabetes. Signs of lactic acidosis can be non-specific, and include: weakness, tiredness, unusual muscle pain, trouble breathing, unusual stomach discomfort, feeling cold, dizziness or lightheadedness, and sudden slow or irregular heartbeat.

Glyburide is capable of producing severe low blood sugar (hypoglycemia). Signs and symptoms of hypoglycemia include sweating, shakiness, confusion, anxiety, hunger, and heart palpitations.

Consumers should exercise caution before using products claiming to be herbal or all-natural alternatives to FDA-approved prescription drugs. Such products may contain harmful amounts of APIs.

Q5. Is it safe to purchase diabetes prescription drugs from online pharmacies?

A. FDA discovered a website selling diabetes prescription drugs and other prescription drugs without requiring a prescription. It is illegal to sell prescription drugs to U.S. consumers without a valid prescription.

Based on a review of online pharmacies by the National Association of Boards of Pharmacy (NABP), only 3 percent of online pharmacies are in compliance with U.S. pharmacy laws and practice standards. The FDA also has no authority over prescription drugs manufactured for sale in other countries. And therefore, the FDA has not evaluated their safety, efficacy, or quality.

Furthermore, drugs not approved by the FDA may also lack the necessary and required labels that ensure their appropriate and safe use. For example, some FDA-approved drugs have serious risks relative to benefits that consumers should be made aware of through a boxed warning or Medication Guide as part of the product labeling. As a result, health care providers and consumers may not be fully informed of the potential serious risk of harm from the use of these products.

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In addition to taking prescription drugs under medical supervision, special information given to the consumer informing them about the potential risks will minimize the chance of adverse outcomes.

For tips on safely buying medicine online, please visit www.fda.gov/BeSafeRx.

Q6. What should consumers do to protect themselves from these products?

A. Although the FDA continues to conduct surveillance to minimize the number of violative and potentially dangerous products on the market, we encourage all consumers to exercise caution before using certain products, particularly those targeting chronic diseases such as diabetes. Please talk with your health care provider to discuss treatment options and before using a new product. Consumers can find more information on medication health fraud on the FDA’s website.

Consumers using any of the products mentioned in the FDA warning letters are urged to discontinue taking the products and speak with their health care providers. Consumers who suspect they have experienced adverse effects as a result of taking any of these products orother suspicious diabetes products should contact their licensed health care provider immediately.

The FDA encourages consumers and health care providers to report harmful effects experienced from using any product claiming to treat or manage diabetes and diabetes complications to FDA’s MedWatch Adverse Event Reporting program by doing one of the following:

• Complete and submit the report online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-1078

Q7. Why is FDA acting now? Has any U.S. consumer been harmed by any of these products?

A. To date, the FDA is not aware of reports of serious adverse events. FDA is taking action to protect the public health from potential harm related to these unapproved products, including the potential harm to consumers who may use these products as a substitute for proper medical treatment.

Q8. How can I get more information about health fraud scams?

A.To learn more about identifying and avoiding health fraud scams visit: www.fda.gov/healthfraud

ResourcesForYou

• Watch Out for Illegally Marketed Products for Diabetes

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