Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products

FDA has developed these questions and answers (Q & A’s) to help consumers, health care practitioners, and the general public understand FDA’s actions regarding weight loss products contaminated with various prescription drugs and chemicals.  Many of these products are marketed as dietary supplements.  Unfortunately, FDA cannot test and identify all weight loss products on the market that have potentially harmful contaminants in order to assure their safety.  Enforcement actions and consumer advisories for unapproved products only cover a small fraction of the potentially hazardous weight loss products marketed to consumers on the internet and at some retail establishments. 

1. What undeclared drugs and/or chemicals are contained in the weight loss products associated with this action? 

Laboratory tests revealed the presence of sibutramine, rimonabant, phenytoin, and phenolphthalein.  A summary of our findings are below:

"*Products added 1/8/2009."

2. What action is FDA taking regarding these tainted weight loss products?

FDA is taking action to help ensure that these products and other products containing undeclared prescription ingredients are removed from the marketplace.  FDA has inspected a number of firms associated with the sale of these products and is currently seeking recalls of the products.  Based on these inspections and the firms’ responses to recall requests, FDA may take additional enforcement steps to include warning letters, seizure, injunction, or criminal charges.

3. What is sibutramine and what are the associated risks?

Sibutramine is a Schedule IV controlled substance and the active pharmaceutical ingredient in Meridia, an approved prescription drug to treat obesity.

Some of the identified products recommend taking more than 3 times the recommended daily dosage of sibutramine.  Because of this, even consumers without a history of health problems that take these high doses of sibutramine may suffer serious adverse effects if they take these products, such as increased blood pressure, tachycardia, palpitations, and seizure. 

Populations who would be at increased risk of serious adverse health effects from consuming a standard dose of sibutramine include:

• Patients with a history of hypertension, especially those with uncontrolled or poorly controlled hypertension.
• Patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
• Patients with narrow angle glaucoma.
• Patients with a history of seizure.
• Patients predisposed to bleeding events and those taking concomitant medications known to affect hemostasis or platelet function.
• Patients with severe hepatic dysfunction.
• Patients concurrently taking the following medications:
  • Sumatriptan
  • Dihydroergotamine
  • Dextromethorphan
  • Meperidine,
  • Pentazocine
  • Fentanyl
  • Lithium
  • Tryptophan
  • MAO inhibitors

4. What is rimonabant and what are the associated risks?

Rimonabant is the active pharmaceutical ingredient in Zimulti which has not been approved in the United States.  In Europe the drug is known as Acomplia.

In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects—seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients.  In June of 2008, the Medicines and Healthcare Products Regulatory Agency of the United Kingdom linked rimonabant to 5 deaths and 720 adverse reactions over the past two years.  In October, the European Medicines Agency recommended that marketing and sales of Accomplia be suspended due to safety concerns. 

5. What is phenolphthalein and what are the associated risks?

Phenolphthalein was an ingredient in some Over-the-Counter laxative products until 1999 when the FDA reclassified the drug as “not generally recognized as safe and effective” after studies indicated that phenolphthalein presented a potential carcinogenic risk. Phenolphthalein has also been found to be genotoxic in that it can damage or cause mutations to DNA. 

6. What is phenytoin and what are the associated risks?

Phenytoin is the active pharmaceutical ingredient in Dilantin, an approved anti-seizure medication.  Because there were trace amounts of this drug in some of these products, the risk was not assessed.  However, these products could pose a risk to consumers who are allergic or hypersensitive to phenytoin.

7. What is bumetanide and what are the associated risks?

Bumetanide is a the active pharmaceutical ingredient in Bumex, a prescription diuretic.  Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Consumers should not take Bumetanide if they are allergic to sulfonamides. Significant drug interactions, such as taking bumetanide with digoxin and lithium, may lead to an increased risk of toxicity. Patients may also be at an increased risk of hypotension (low blood pressure), fainting, and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication. The risk of toxic reactions to the drug may be greater in elderly consumers or consumers with impaired renal function.

8. Who are the manufacturers of these products?

Many of these products do not list the manufacturer on the label or in the advertisements.  However, most of the products appear to have been manufactured in China.

 9. Does FDA regulate these products?

Although some of the identified products are marketed as “dietary supplements”, all of these products should have been submitted to the FDA for approval prior to marketing.  Regulatory requirements for dietary supplements differ from those covering "conventional" foods and drug products (prescription and Over-the-Counter).  Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that its products are safe before they are marketed. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.

Manufacturers must make sure that product label information is truthful and not misleading.  However, products which contain an ingredient that has been approved as a new drug such as sibutramine or an ingredient that does not supplement the diet are not considered to be dietary supplements. Consequently these products should also have been submitted to FDA for approval prior to their marketing. 

10. Will there be recalls?

It is anticipated that several of these products will be recalled.  Recalls and instructions for returns can be found at: http://www.fda.gov/opacom/7alerts.html.

11. Are there more contaminated products like these on the market?

More and more products tainted with prescription drugs, including drugs for erectile dysfunction, diabetes, and obesity, are finding their way into the U.S. marketplace.  Many are labeled as dietary supplements or supplements.  FDA takes this escalating issue very seriously, and is committed to doing all that it can to identify and remove these dangerous products from the market.  However, unfortunately, it is not possible for FDA to test and identify all tainted products. 

12. What can consumers do to help protect themselves from harm?   

Consult with your health care professional before taking dietary supplements to treat obesity or other diseases. All consumers should be familiar with the following signs of health fraud:

• Promises of an "easy" fix for problems like excess weight, hair loss, or impotency.
• Claims such as "scientific breakthrough," "miraculous cure," "secret ingredient," and "ancient remedy."
• Impressive-sounding terms, such as "hunger stimulation point" and "thermogenesis" for a weight loss product.
• Claims that the product is safe because it is "natural."
• Undocumented case histories or personal testimonials by consumers or doctors claiming amazing results.
• Promises of no-risk, money-back guarantees.

 

For more information, please see FDA News.

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Date created: December 22, 2008; Updated January 8, 2009

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