Potential Health and Safery Concerns Results in FDA Probe of Caffeinated Alcoholic Beverages

The US Food and Drug Administration (FDA) today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs.

Of the combined use of caffeine and alcohol among U.S. college students in the few studies on this topic, the prevalence was as high as 26 percent.

Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS). FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS. For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.

The FDA alerted manufacturers to the fact that the agency is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned. To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. It has not approved caffeine for use at any level in alcoholic beverages.

The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned. FDA's letter informed each company that if FDA determines that the use of caffeine in the firm's alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace.

In the past year, Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages, Tilt and Bud Extra and Sparks, and agreed to not produce any caffeinated alcoholic beverages in the future.

The federal agency with primary responsibility for regulating alcoholic beverages, the Treasury Department's Alcohol and Tobacco Tax and Trade Bureau, requires that alcoholic beverages contain only ingredients that satisfy FDA's requirements for use.

In late September, the FDA received a letter from 18 Attorneys General and one city attorney expressing concerns about caffeinated alcoholic beverages.

Survey Shows that Diabetic Nerve Pain Significantly Impacts Daily Activities

In a new online survey conducted among 553 men and women, 18 and older who have either type I or II diabetes and are suffering from diabetic nerve pain in the United States, eighty-five percent said that their pain was one of the top three most bothersome complications of their diabetes.

Despite the fact that people with diabetic nerve pain recognize the condition's impact on their lives and eighty-four percent of those surveyed said they have discussed the condition with a healthcare provider, just slightly less than half of respondents (49 percent) were treating their pain.

The survey was fielded as part of a new educational campaign, "Take the Next Step," which is designed to help people with diabetes recognize the symptoms of painful diabetic peripheral neuropathy (pDPN) and proactively talk to their healthcare professional about incorporating the treatment of pDPN into their overall diabetes care, which may include blood sugar control, diet, pain management, exercise or other changes in lifestyle. The initiative is supported through a sponsorship by Pfizer Inc.

Taking Control of Your Diabetes (TCOYD), a leading non-profit organization dedicated to educating people about diabetes, and Kim Lyons, personal trainer and nutritionist featured on NBC's hit show, "The Biggest Loser," are participating in this campaign to raise awareness of pDPN, one of the most common and debilitating complications of diabetes. "Take the Next Step" features an activity program developed by Lyons to demonstrate activities that are appropriate for people with diabetes and help people with pDPN understand how increasing their activity level can help them control their pain.

"Optimal blood sugar control has been shown to prevent the onset and delay the progression of pDPN and ease its symptoms," said Steven Edelman, MD, Founder and Director of the not-for-profit 'Taking Control of Your Diabetes' and Professor of Medicine, University of California at San Diego. "Given the debilitating impact of pDPN, such as on a person's ability to be physically active and to fall asleep at night, treating the pain can really make a difference for these patients and help them get back to normal daily activities which in turn can help them better manage their diabetes."

Many patients are unaware of treatment options.
Of the people surveyed, almost two-thirds (64 percent) said that their nerve pain interfered with the daily activities that matter to them. The most common activities that respondents said were impacted by their pain were exercising (76 percent), falling asleep (71 percent) and spending time with or caring for family (68 percent). Of the more than half of those surveyed who were not being treated (51 percent), less than a third (32 percent) were aware of treatments that are approved to treat the condition.

Currently, nearly 24 million Americans suffer from diabetes. Approximately 20 percent of people with diabetes experience painful diabetic peripheral neuropathy, most commonly caused by poorly controlled blood sugar levels that result in nerve damage over time. Symptoms of pDPN may include burning, throbbing or painful tingling in the feet or hands.

The pain associated with the condition can become extremely debilitating, affecting patients' everyday activities such as the motivation needed to exercise and be active and the ability to fall asleep. Difficulty maintaining an active lifestyle can hamper patients' ability to control their weight, an important key to diabetes management. Treatment guidelines point to the unique nature of pDPN and the need for specialized treatment, which can include prescription treatment for the pain.

"I was motivated to be a part of this campaign because I've seen the benefits of activity for people who suffer from pDPN," said Kim Lyons. "I know that for people with this kind of pain, engaging in physical activity might seem daunting at first, but people will be amazed to see that taking small steps towards increasing activity level can make a big difference."

Prevention, early diagnosis and aggressive treatment are critical
People with diabetes can develop nerve pain at any time, but the risk is greater the longer a person has suffered from diabetes, with the highest rates among those who have had the condition for at least 25 years. In the early stages of nerve damage, some people have no symptoms, or may have numbness or tingling in the feet. These symptoms can be mild at first and because nerve damage can occur over several years, these cases may go unnoticed until the nerve damage progresses and becomes painful, sometimes leading to painful diabetic peripheral neuropathy (pDPN).

A number of prescription medications are approved by the U.S. Food and Drug Administration (FDA) to help relieve the specific symptoms of pDPN. These medications can play an important role in helping to reduce the pain associated with this condition. Over-the-counter pain medicines such as acetaminophen and ibuprofen are frequently used, but have not been specifically approved by the FDA to treat painful diabetic peripheral neuropathy.

For more information:

• Diabetes Pain Help

Ongoing Safety Review of Weight Loss Drug Orlistat

The U.S. Food and Drug Administration announced today that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical (orlistat 120 mg) and the over-the-counter medication Alli (orlistat 60 mg).

The drugs were approved for obesity management in conjunction with a reduced caloric diet, and to reduce the risk of regaining weight after prior weight loss.

Between 1999 and 2008, the FDA received 32 reports of serious liver injury, including 6 with liver failure, in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

Reports outlining the adverse events were submitted to FDA’s Adverse Event Reporting System.The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA’s Center for Drug Evaluation and Research Drug Safety Oversight Board.

“The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services,” said Steven Osborne, M.D., executive director of the Board.The FDA’s analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time.

Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.Consumers who have used orlistat should consult a health care professional if they experience symptoms possibly associated with development of liver injury, particularly weakness or fatigue, fever, jaundice, or brown urine.

Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.The FDA urges both health care professionals and consumers to report suspected side effects from the use of orlistat to FDA's MedWatch Adverse Event Reporting program

Further information regarding orlistat will be released by the FDA as soon as its review of complete.

Orlistat is manufactured by Swiss pharmaceutical firm Roche. The drug is marketed as Alli by British drugmaker GlaxoSmithKline PLC and sold as Xenical by Roche. The FDA first approved Xenical in 1999 and alli in 2007. Glaxo reported $123 million in sales for Alli in 2008, while Roche posted $472 million in revenue for Xenical.

Dietary Supplement and Protein Powder Manufacturers Companies Failed to Declare Allergens in Products

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees operations at all three companies.

The companies, located in Paterson, N.J., manufacture dietary supplements and protein powders and distribute them throughout the United States. The companies also export powder mixes and dietary supplements for sale by private label customers.

The government's complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.

Undeclared Ingredients

The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems.

During a recent inspection, FDA investigators found that several of the companies’ products contained milk ingredients that were not declared on the product labels. In addition, the company failed to clean processing equipment between batches and control allergens in the facility.

FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.

Failing to correct filthy conditions

In three inspections, FDA investigators noted deviations from GMP standards. The companies promised to make corrections, but they failed to do so. The complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.

“This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”

Consumers with allergies to milk ingredients who have used these products and are experiencing any symptoms should contact their health care professional.

Tainted Weight Loss Pills Put Consumers’ Health at Risk

Earlier this week, the U.S. Food and Drug Administration (FDA) alerted consumers in North America not to purchase or consume one of more than 25 different products marketed for 'weight loss' because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk and lead to such health problems as high blood pressure, seizures, heart attack, or stroke.

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products, often marketed as ‘dietary’or ‘food supplements,’ include sibutramine (a controlled substance, manufactured and legally distributed by Abbott Laboratories as Meridia in the U.S. and Canada, and Reductil in Europe and most other countries), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels.

Prescription drugs vs. supplements
The Dietary Supplement Health and Education Act, commonly known as DSHEA, does not qualify dietary or food supplements as ‘drugs’ As a result, many of these products fall outside the realm of the FDA regulations for (prescription) drugs. While pharmaceutical companies must meet rigorous conditions for manufacturing, packaging, labeling, advertising and distribution of prescription drugs, dietary and food supplements do not require any proof. However, supplement labels are supposed to exactly state what’s in the product. Unfortunately, as this FDA analysis shows, this is not always the case.

While prescription drugs are monitored by the FDA, the agency does not monitor ‘dietary’or ‘food supplements’ as they do prescription drugs. In this case however, the FDA warned against the use of supplements contaminated with a variety of unlisted pharmaceuticals. Some of these active pharmaceutical ingredients may be approved for marketing as prescription drugs in the United States or Europe. However, the fact that these products are not listed as ingredients on the supplement product labels, as required by law, or exceeds recommended dosage levels, is a violation of existing regulations and a major concern to medical authorities. Dr Robert Mayr, an internationally recognized expert on dietary supplements, noted that: ‘There is a real danger that these ‘weight loss pills’ are putting consumers' health at risk.’

These weight loss products are often promoted and sold on web sites and in some retail stores. Some of the products claim to be ‘natural’ or to contain only ‘herbal’ ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. Therefor, these products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.

The FDA advises consumers who have used any of these products to stop taking them and consult their health care professional immediately. The FDA encourages consumers to seek guidance from a health care professional before purchasing weight loss 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 their maximum recommended dosages,’ said Dr Janet Woodcock, MD., director, Center for Drug Evaluation and Research, FDA. ‘Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.’

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 health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.

In October 2008 the European Medicines Agency (EMEA) completed a review of rimonabant following concerns over the medicine’s psychiatric safety. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of rimonabant no longer outweigh its risks, and that its marketing authorisation should be suspended across the European Union (EU). Following these conclusions, Sanofi-Aventis, in November 2008, decided to discontinue the ongoing rimonabant clinical development program in all indications.

When in doubt...
Consumers in doubt about any ‘weight loss’ or dietary supplement they are currently using, should make sure to contact the manufacturer or distributor listed on the label. In all cases, health care professionals and consumers should report serious adverse events or side effects and product quality problems to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

The tainted weight loss products include the following products and brands:

• Fatloss Slimming
• 2 Day Diet
• 3x Slimming Power
• Japan Lingzhi 24 Hours Diet
• 5x Imelda Perfect Slimming
• 3 Day Diet
• 7 Day Herbal Slim
• 8 Factor Diet
• 7 Diet Day/Night Formula
• 999 Fitness Essence
• Extrim Plus
• GMP
• Imelda Perfect Slim
• Lida DaiDaihua
• Miaozi Slim Capsules
• Perfect Slim
• Perfect Slim 5x
• Phyto Shape
• ProSlim Plus
• Royal Slimming Formula
• Slim 3 in 1
• Slim Express 360
• Slimtech
• Somotrim
• Superslim
• TripleSlim
• Zhen de Shou
• Venom Hyperdrive 3.0