Tainted products marketed as dietary supplements potentially dangerous. FDA statement letter

December 23, 2010

 

December 23, 2010 – This blog post presents a letter sent out by the American Food and Drug Administration (FDA). The letter addressed the issue of undeclared drugs or drug analogues in dietary supplements mostly geared towards (sexual)  performance enhancements, weight loss products, and/or body building products. While the FDA addresses with its statement letter manufacturers, distributors and consumers in the US, the problem seems to exist worldwide, and everyone taking such products may find useful information as to her/his own safety in the statement by the FDA, which follows here below.

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The U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.

In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

The FDA’s letter emphasizes that manufacturers and distributors are responsible for ensuring that their products comply with the law. Five major trade associations – Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association– are joining FDA on a call for media and have agreed to share the letter widely within the industry.

“These tainted products can cause serious adverse effects, including strokes, organ failure, and death,” said FDA Commissioner Margaret A. Hamburg, M.D. “The manufacturers selling these tainted products are operating outside the law.”

The FDA is seeking input and collaboration from dietary supplement trade associations to educate the industry about this problem and to help develop new strategies to combat it, according to Hamburg. The agency also announced a new RSS feed to warn consumers more quickly about tainted products marketed as dietary supplements.

The FDA has noted the three most common categories of these illegal products:

  • Weight loss products containing active ingredients such as sibutramine: Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty, Solo Slim, Slim-30, and others, which contain sibutramine or closely related drugs (analogs).
  • Body-building products containing anabolic steroids or steroid analogs: These products can cause acute liver injury and increase the risk for heart attack, stroke and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.
  • Sexual enhancement products that contain the same active ingredient or an analog of the active ingredient in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription, and they should not be used by people who have certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee, and others.

“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,” said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research. “Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”

Companies that make or distribute tainted products may receive warning letters and/or face enforcement actions such as product seizures, injunctions, and criminal prosecution. Responsible individuals may also face criminal prosecution.

Lawful dietary supplements contain minerals, vitamins or other dietary ingredients and are intended to be an addition to a standard diet. The FDA regulates these products under the Dietary Supplement Health and Education Act, passed by Congress in 1994. Unlike drugs, dietary supplements do not have to be approved by the FDA prior to marketing. Dietary supplement manufacturers and distributors are responsible for selling a safe product. FDA’s Current Good Manufacturing Practices require dietary supplement manufacturers to have proper manufacturing and quality assurance controls in place to ensure the quality of their products, including controls to prevent the inclusion of contaminants that could adulterate their products.

More information can be found under the following links:

Letter to Industry: http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/UCM236985.pdf

Tainted Products Marketed as Dietary Supplements: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm236774.htm

RSS Feed: http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml

Tainted Body Building Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/ucm234523.htm

Tainted Sexual Enhancement Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234539.htm

Tainted Weight Loss Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/ucm234592.htm

Photos of Tainted Products Marketed as Dietary Supplements: http://www.flickr.com/photos/fdaphotos/sets/72157625502079212/

Dietary Supplements: http://www.fda.gov/Food/DietarySupplements/default.htm

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Que She Herbal Supplement Has It All: Undeclared Drug Ingredients Fenfluramine, Propranolol, Sibutramine, Ephedrine

July 11, 2010

July 11, 2010 – Do the people behind such products at all know what they do?

On July 08, 2010, the FDA has issued the following warning concerning the Que She Herbal Supplement and its Undeclared Drug Ingredients:

AUDIENCE: Consumer, Pharmacy

ISSUE: FDA warned consumers and healthcare professionals that Que She, marketed as an herbal weight loss supplement, contains unlisted and active pharmaceutical ingredients that could harm consumers, especially those with cardiovascular conditions. These active pharmaceutical ingredients also may interact with other medications and result in a serious adverse event.

BACKGROUND: Que She, advertised as “Slimming Factor Capsule” and as “an all-natural blend of Chinese herbs,” has been widely distributed on Internet sites such as the Bouncing Bear Botanicals website, and at retail outlets, including Sacred Journey in Lawrence, Kansas.

FDA analysis of Que She found that it contains:

  • Fenfluramine – a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage;
  • Propranolol – a prescription beta blocker drug that can pose a risk to people with bronchial asthma and certain heart conditions;
  • Sibutramine – a controlled substance and prescription weight loss drug, sibutramine was the subject of a recent study whose preliminary findings showed an association between sibutramine use and increased risk of heart attack and stroke in patients who have a history of heart disease;
  • Ephedrine – a stimulant drug that is legally marketed over-the-counter for temporary relief of asthma but can pose a risk to people with certain cardiovascular conditions.

    RECOMMENDATIONS: People who have purchased Que She should stop taking the product immediately and consult a health care professional.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Online Reporting Program at www.fda.gov/MedWatch/report.htm. Other avenues of reporting also exist.

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    FDA urges consumers to stop using Hydroxycut products because of the danger of serious liver injuries

    May 2, 2009

    May 01, 2009 – FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc. Hydroxycut products are associated with a number of serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

    FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

    Read the complete MedWatch Safety summary including links to the FDA news release, Q&A’s and a listing of all products included in this alert here.


    Nationwide Voluntary Recall of Dietary Supplement Products Found to Contain Sibutramine, an Undeclared Drug Ingredient

    April 23, 2009

    April 20, 2009 — Universal ABC Beauty Supply International has been informed by the Food and Drug Administration (FDA) that FDA lab analyses of the dietary supplements distributed by the company were found to contain undeclared Sibutramine, the pharmacologically active ingredient of the FDA-approved Reductil, used as an appetite suppressant for weight loss. As a consequence, Universal ABC Beauty Supply International voluntarily recalls the affected products (as listed below) nationwide because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers.

    These dietary supplements are not supposed to contain Sibutramine. The FDA has not approved these products, therefore the safety and effectiveness of these products is unknown. FDA advises that these products pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

    All lots of the following dietary supplement products are being recalled:

    1.   ProSlim Plus, 60 capsules, bottle in box
    2.   3 DAYS fit, 60 capsules, bottle in box
    3.   EIGHT FACTOR DIET, 60 capsules, 3 pouches/box
    4.   24hours Diet, 60 capsules
    5.   Slim 3in1 M-18 ROYAL DIET, 90 capsules, 3 pouches/box
    6.   3X SLIMMING POWER, 60 capsules, bottle in box
    7.   Extrim Plus 24 Hours RE-BURN Formula, 60 capsules
    8.   Slim 3in1 EXTRA SLIM FORMULA, 90 capsules, 3 pouches/box
    9.   Slim 3in1 EXTRA SLIM WAIST FORMULA, 90 capsules, 3 pouches/box
    10. SLIM EXPRESS 360º C
    11. SLIM EXPRESS 4in1, 60 capsules, bottle in box
    12. ROYAL SLIMMING FORMULA, 60 capsules, bottle/box
    13. BODY CREATOR, 90 capsules, 3 pouches/box
    14. Slim Waistline (labeling written in Chinese)
    15. BODY SHAPING, 90 capsules, 3 pouches/box
    16. PERFECT SLIM, 90 capsules, 3 pouches/box
    17. Perfect Slim 100% Natural Herbal Essence
    18. IMELDA Perfect Slim
    19. Slim Waist Formula, 32 capsules, 2 pouches/box
    20. Super Slimming, 60 capsules, bottle in box
    21. 2 DAY DIET
    22. Powerful Slim
    23. BODY SHAPING
    24. SUPER FAT BURNER, 60 capsules, bottle in box
    25. SLIMMING FORMULA
    26. SLIM FAST 2, 32 capsules, 2 pouches/box
    27. SLIM FAST, 60 capsules, 3 pouches/box
    28. Slim up, 120 capsules, bottle in box
    29. 7 DAYS DIET, 60 capsules, 3 pouches/box
    30. Perfect Slim Up, 60 capsules, bottle in box
    31. JM Fat Reducer
    32. SlimBurn
    33. 21 Double SLIM
    34. TRIM PLUS 2

    The company has discontinued distribution of these products. It sincerely regrets any inconvenience to customers. Consumers should not consume the above products and should return the dietary supplements on hand to the place of purchase for a full refund or partial refund of the unused portion.

    Please find the original announcement by the FDA and the press release by the company here and here, respectively.


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