Agency working with trade associations to increase company vigilance and protect public

In a letter sent today to dietary supplement manufacturers, 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 feed¹ 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 products² containing active ingredients such as sibutramine: Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn³ from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty⁴, Solo Slim⁵, Slim-30⁶, and others, which contain sibutramine or closely related drugs (analogs).
• Body-building products⁷ 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 products⁸ 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-25⁹, Duro Extend Capsules for Men¹⁰, Magic Power Coffee¹¹, 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.

For more information:

Letter to Industry: http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/UCM236985.pdf¹²

Tainted Products Marketed as Dietary Supplements: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm236774.htm ¹³

RSS Feed: http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml¹⁴

Tainted Body Building Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/ucm234523.htm¹⁵

Tainted Sexual Enhancement Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234539.htm¹⁶

Tainted Weight Loss Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/ucm234592.htm¹⁷

Photos of Tainted Products Marketed as Dietary Supplements: http://www.flickr.com/photos/fdaphotos/sets/72157625502079212/¹⁸

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

Technorati Tags: diet, health, health supplements, weight loss

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Ignoring the recommendation of its own advisory committee, the Food and Drug Administration on Tuesday declined to approve the weight-loss drug Contrave, the third such drug the agency has kept off the market in recent months.

The agency concluded that the benefits of the drug — about 50% of patients were able to lose 5% of their body weight in clinical trials, compared with 10% of those receiving placebos — were not sufficient to outweigh the potential risks and the potential for abuse. Many patients receiving the drug had a slight increase in blood pressure and pulse rates.

The FDA notified the drug’s manufacturer, Orexigen Therapeutics Inc. of San Diego, that it would have to conduct a large clinical trial of the drug to test for possible cardiovascular complications in the elderly and the obese before the medication could be marketed, according to a statement released by the company.

Such a trial would probably take three to five years and cost as much as $200 million. Most analysts think such a trial is probably beyond the resources of Orexigen, which is focused solely on the development of anti-obesity drugs and has no other products on the market. The company’s stock fell 73% to close at $2.50 in Nasdaq trading Tuesday after the FDA announcement.

At a December meeting, the FDA advisory panel voted 13 to 7 in favor of approving Contrave, arguing that the potential cardiovascular problems could be addressed in a post-marketing study. If that had been the case, Orexigen’s marketing partner, Japan’s Takeda Pharmaceutical Co., would have shared in the cost of the study.

Contrave is a combination of two drugs already on the market: naltrexone, a drug used to combat alcohol and drug addiction, and bupropion, an antidepressant better known by its brand name Wellbutrin. Market analysts had predicted that, if approved, Contrave could have had yearly sales of $1.2 billion by 2018.

In October, the FDA rejected the proposed weight-loss drug Qnexa because of concerns about heart problems and birth defects. That same month, the agency rejected another experimental diet drug called Lorqess that appeared to cause tumor growth in animals. Also in October, the weight-loss drug Meridia was pulled from the market because of concerns that it boosted the rate of heart attacks and strokes.

Hence is seems like the FDA is exercising more vigilance in the approval of weighloss products, even though they are not considered as medicinal products. To me, that’s good news as it is time to product public safety as these products are too easily available to the public.

Technorati Tags: contrave, diet, fda, orexigen therapeutics

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Technorati Tags: diet pills, fda, fruta planta, recall

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Agency alerts consumers to the finding of new undeclared drug ingredients

The U.S. Food and Drug Administration is expanding, for the second time, its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients.

The FDA has identified additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat). The current list now includes the following 72 products:

* This product should not be confused with the line of meal replacement and related products that are marketed as conventional foods under the brand name “Slim-Fast®”.  The manufacturer of Slim-Fast®, Unilever United States, Inc., maintains that the Slim Fast product which appears on this list is not in any way associated with, sponsored or approved by, or otherwise related in any way to the Slim-Fast® brand of meal replacement and related products.

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health.”

On Dec. 22, 2008, the FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. On Jan. 8, 2009, the FDA expanded the list of tainted weight loss products to include 41 additional tainted products. The FDA will continue to update this list as warranted.

The products listed above, some of which are marketed as dietary supplements, are promoted and sold on various Web sites and in some retail stores and beauty salons. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the products’ labels or in promotional advertisements. These products have not been approved by the FDA, are illegal, and include the following undeclared active pharmaceutical ingredients:

• sibutramine (an appetite suppressant available by prescription only and a controlled substance)
• fenproporex – a controlled substance not approved for marketing in the United States;
• fluoxetine – an antidepressant available by prescription only;
• bumetanide – a potent diuretic available by prescription only;
• furosemide – a potent diuretic available by prescription only;
• rimonabant – a drug not approved for marketing in the United States;
• cetilistat – an experimental obesity drug not approved for marketing in the United States;
• phenytoin – an anti-seizure medication available by prescription only; and
• phenolphthalein – a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.

The FDA has inspected a number of companies associated with the sale of these illegal products and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

The FDA advises consumers who have used any products containing these ingredients to stop taking them and consult their health care professional immediately. The FDA also encourages consumers to seek guidance from a health care professional before purchasing weight loss products.

The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke. Sibutramine, a controlled substance, was found in many of these products at levels much higher than the maximum daily dosage for Meridia, the only FDA-approved drug product containing sibutramine. These higher levels of sibutramine can increase the incidence and severity of these health risks. Fenproporex, another controlled substance, can cause arrhythmia and possible sudden death.

Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

• Online
• Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 800-FDA-0178
• Phone: 800-FDA-1088

For more information:

Information on FDA’s Initiative Against Contaminated Weight Loss Products

To learn more about the FDA’s initiative against unapproved drugs see the FDA’s Compliance Policy Guide at: http://www.fda.gov/cder/Guidance/6911fnl.htm.

For drug safety information, see: FDA’s Drug Safety Initiative.

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FDA alleged ‘Body-building’ products contained unapproved food additive, new dietary ingredient and these products will now be destroyed

The U.S. District Court for the Eastern District of Michigan, Southern Division, today entered a consent decree that condemns and forfeits to the United States for destruction about $1.3 million worth of dietary supplements.

“The court order is the result of efforts by the federal government to protect consumers from products for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury,” said Michael Chappell, FDA’s acting associate commissioner for regulatory affairs. “It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace.”

At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Mich. The seized products were marketed for use by body builders and distributed on the Internet and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.”

Based on laboratory tests, the FDA determined that the products contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to assure that the ingredients do not present a significant or unreasonable risk of illness or injury. Specifically, the condemned Methyl 1-D and Methyl 1-D XL contained 1,4,6-androstatriene-3,17-dione, also known as “ATD” or 1,4,6-etioallocholan-dione. The condemned Formadrol Extreme XL contained ATD and 3,6,17-androstenetrione (also known as “6-OXO”). Both of these substances are steroids that inhibit the activity of the enzyme aromatase and may be found in dietary supplements promoted to boost testosterone levels.

The FDA has no scientific information concerning the safety of the condemned products or their ingredients and, thus, cannot determine whether they represent a hazard to consumers. Under the circumstances, consumers who use or have used the products should discuss their use with their health care professionals.
The FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products’ use.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

• Online
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088

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