FDA Advises Consumers Not To Use Certain Zicam Cold Remedies

Intranasal Zinc Product Linked to Loss of Sense of Smell

For Immediate Release:

The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

The products are:

• Zicam Cold Remedy Nasal Gel
• Zicam Cold Remedy Nasal Swabs
• Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”

People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.

“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of CDER’s Office of Compliance.

Health care professionals and consumers are encouraged to report adverse events (side effects) that may be related to the use of these products to the FDA's MedWatch Adverse Event
Reporting program online, by regular mail, fax or phone.

Regular Mail: use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

Fax: 800-FDA-0178

Phone: 800-FDA-1088

For more information: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm166834.htm

FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims

For Immediate Release: June 15, 2009

Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

The U.S. Food and Drug Administration is enforcing the laws that protect consumers from illegal products marketed through the Internet that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 flu virus.

On May 1, 2009, the FDA warned consumers regarding products related to the 2009 H1N1 flu virus offered on the Internet. The products involved are those that are promoted and marketed to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus but are not approved, cleared, or authorized by the FDA. The agency advised operators of offending Web sites that they must take immediate action to ensure that they are not marketing products intended to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus that have not been cleared, approved, or authorized by the FDA.

Since then, the FDA has issued more than 50 warning letters to offending Web sites and as a result, more than 66 percent of these Web sites have removed the offending claims and/or products.

“We are committed to aggressively pursuing those who attempt to take advantage of a public health emergency by promoting and marketing unapproved, uncleared, or unauthorized products,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “We have achieved some success and will remain vigilant in our efforts to protect consumers from these fraudulent, potentially dangerous products.”

Examples of unapproved, uncleared, or unauthorized products targeted by the FDA include:--A shampoo that claimed to protect against the H1N1 flu virus;--A dietary supplement that claimed to protect infants and young children from contracting the H1N1 flu virus;--A “new” supplement that claimed to cure H1N1 flu infection within four to eight hours;--A spray that claimed to leave a layer of ionic silver on one’s hands that killed the virus;--Several tests that have not been approved to detect the H1N1 flu virus; and--An electronic instrument costing thousands of dollars that claimed to utilize “photobiotic energy” and “deeply penetrating mega-frequency life-force energy waves” to strengthen the immune system and prevent symptoms associated with H1N1 viral infection.

The FDA’s warning letters are consistent with an aggressive strategy the agency put into place to protect consumers from individuals or businesses that promote fraudulent claims for products in an attempt to take advantage of the public’s concerns about the 2009 H1N1 flu virus.
Unapproved, uncleared, or unauthorized products that claim to diagnose, mitigate, prevent, treat or cure the 2009 H1N1 flu are illegal and a potentially significant threat to the public health.

These warning letters were the result of daily Internet surfs conducted by the FDA’s Office of Enforcement, Office of Criminal Investigations, and staff from the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, and the Center for Food Safety and Applied Nutrition. The warning letters issued by e-mail and the FDA requested a response within 48 hours.

In addition, the FDA posted the offending Web sites and products on the agency’s Web site.
“Taking swift action to inform unsuspecting consumers about products that could be dangerous to their health is a major priority for the FDA,” said Hamburg.

The FDA will consider further civil or criminal enforcement action against those Web sites that fail to resolve the violations cited in warning letters. Actions could include seizure, injunction, and criminal prosecution.

For more information:
FDA’s Fraudulent H1N1 Flu Virus Product List

Browse Warning Letters for: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus
Report Suspected Fraudulent Products or Criminal Activity Associated with H1N1 Flu Virus (Swine Flu)

FDA Uncovers Additional Tainted Weight Loss Products

FOR IMMEDIATE RELEASE

Consumer Inquiries: 888-INFO-FDA

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:

2 Day DietFatloss SlimmingSlim 3 in 1 M18 Royal Diet
2 Day Diet Slim AdvanceGMPSlim 3 in 1 Slim Formula
2x Powerful SlimmingHerbal XenicolSlim Burn
3 Day DietImelda Fat ReducerSlim Express 4 in 1
3 Days FitImelda Perfect SlimSlim Express 360
3x Slimming PowerJM Fat ReducerSlim Fast*
5x Imelda Perfect SlimmingLida DaiDaihuaSlim Tech
7 Day Herbal SlimMeiliSlim Up
7 Days DietMeizitangSlim Waist Formula
7 DietMiaozi MeiMaoQianZiJiaoNangSlim Waistline
7 Diet Day/Night FormulaMiaozi Slim CapsulesSlimbionic
8 Factor DietNatural ModelSliminate
Eight Factor DietPerfect SlimSlimming Formula
21 Double SlimPerfect Slim 5xSomotrim
24 Hours DietPerfect Slim UpStarcaps
999 Fitness EssencePhyto ShapeSuper Fat Burner
BioEmagrecimPowerful SlimSuperslim
Body CreatorProSlim PlusSuper Slimming
Body ShapingReduce WeihgtTrim 2 Plus
Body SlimmingRoyal Slimming FormulaTriple Slim
Cosmo SlimSana PlusVenom Hyperdrive 3.0
Extrim PlusSlim 3 in 1Waist Strength Formula
Extrim Plus 24 Hour ReburnSlim 3 in 1 Extra Slim FormulaXsvelten
Fasting DietSlim 3 in 1 Extra Slim Waist FormulaZhen de Shou

* 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:

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: www.fda.gov/MedWatch/report.htm
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

Information on these products for consumers and health care professionals can be found at: http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm

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.

The Latest Information on the Salmonella Outbreak

As the well-publicized nationwide salmonella outbreak broadens in scope, the Amherst Health Department would like to provide citizens of Amherst with the most up-to-date information available to us, and this blog will be updated regularly for the benefit of Amherst citizens seeking information.

To the best of our knowledge, all Amherst-area grocery outlets have removed recalled products from their shelves. However, consumers may still have previously purchased products in their cabinets that must be identified and disposed of. To that end, we are providing several important links which consumers can access to obtain the most accurate recall lists made available by the FDA and CDC.

For an accurate list of recalled products, please click here for access to the FDA's list which is updated on a daily basis to reflect the latest additions.

To access the FDA's Peanut Butter Recall Blog, please click here.

To see a YouTube video of The FDA's Dr. Stephen Sundlof discussing the do's and don'ts of the peanut butter outbreak, simply click here.

If you have further questions or concerns, please do not hesitate to contact the Amherst Health Department at 259-3077.

Peanut Butter Product Recall

For those curious about the state of the peanut butter product recall, the CDC and FDA both report that "no association has been found with major national brand name jars of peanut butter sold in grocery stores."

Again, if consumers have any questions regarding the product recall, please visit the FDA website for an updated list of recalled products and an overview of the recent salmonella outbreak.

Peanut Butter-Related Salmonella Outbreak Update

As the list of recalled products expands related to the recent outbreak of Salmonella, the CDC has made several simple recommendations for American Consumers:

1) Do not eat products that have been recalled and throw them away in a manner that prevents others from eating them

2) Postpone eating other peanut butter containing products (such as cookies, crackers, cereal, candy and ice cream) until information becomes available about whether that product may be affected.

So far, 474 people have been sickened in 43 states, with 107 individuals hospitalized and 6 deaths potentially linked to the outbreak. 40 of the 474 infected individuals reside in Massachusetts.

The CDC states:

"Of the 458 persons with available data, illness onsets were between September 8, 2008 and January 2, 2009. Age range was 1-98."

For the latest list of recalled products, please visit the related page on the website of the Food and Drug Administration, available by clicking here. For general information on salmonella, please click here.

As always, please feel free to call Keith Carlson, Public Health Nurse for the Town of Amherst, at 413-259-3161 for further information.