Awareness >> Government Warnings and Announcements
United States Government Warnings and Announcements
The information on this page was obtained from the FDA or CPSC. For more information on these and other government warnings, please visit www.fda.govor www.cpsc.gov.
September 8, 2009
CDC Guidance for Childcare and Early Childhood Programs for 2009-2010 Influenza Season.
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.
June 9, 2009
Acting Surgeon General Issues ‘Call to Action To Promote Healthy Homes'
The U.S. Food and Drug Administration announced today that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products.
May 1, 2009
CDC: Update on School (K – 12) Dismissal and Childcare Facilities: Interim CDC Guidance in Response to Human Infections with the 2009 Influenza A H1N1 Virus
Based on new information on circulation of a new influenza A (H1N1) virus among people in the US and Mexico first detected in April, 2009, this document provides updated interim planning guidance for State, territorial, tribal, and local communities. This guidance includes recommendations on school dismissal for K – 12 schools and closure of childcare programs and facilitiesand updates previously issued guidance on community mitigation interventions for this disease (April 28, 2009,
School dismissal and childcare closures are an important part of a comprehensive, layered mitigation approach aimed at reducing disease transmission and associated morbidity and mortality during the 2009 H1N1 virus outbreak in the US.
As of April 25 at 7:30 PM ET, CDC has confirmed 11 human cases of swine flu in the United States: seven in California, two in Texas, and two in Kansas. CDC continues to investigate other suspected cases. Investigations are ongoing to determine the source of the infection and whether additional people have been infected with similar swine influenza viruses.
CDC is working very closely with state and local officials in California, Texas, as well as with health officials in Mexico, Canada and the World Health Organization. On April 24th, CDC deployed 7 epidemiologists to San Diego County, California and Imperial County, California and 1 senior medical officer to Texas to provide guidance and technical support for the ongoing epidemiologic field investigations. CDC has also deployed to Mexico 1 medical officer and 1 senior expert who are part of a global team that is responding to the outbreak of respiratory illnesses in Mexico.
Influenza is thought to spread mainly person-to-person through coughing or sneezing of infected people. There are many things you can to do toprevent getting and spreading influenza. Visit the CDC Swine Flu website to learn more >>
CDC has posted several new swine flu documents and resources in the past few days, including the following:
Taking Care of a Sick Person in Your Home
Safe travel information for the U.S. and Mexico
Swine Flu Video Podcast
Swine Influenza and You
April 22, 2009
New Strain of Swine Flu in Two Children in California Neither child had contact with pigs; the source of the infection is unknown. The lack of known exposure to pigs in the two cases increases the possibility that human-to-human transmission of this new influenza virus has occurred.
Consumers warned not to eat Strubs Norwegian Style Sliced Smoked Steelhead Salmon in 300 gram packages because of potential contamination with the bacterium Listeria monocytogenes.
March 31, 2009
FDA Alerts Consumers to Recall of Certain Pistachios
The FDA and the California Department of Public Health (CDPH) are investigating Salmonella contamination in pistachio products sold by Setton Pistachio of Terra Bella Inc, Calif. The company has stopped all distribution of processed pistachios and will issue a voluntary recall involving approximately 1 million pounds of its products.
The U.S. Food and Drug Administration is advising retailers and food service operators not to offer for sale oysters harvested between Feb. 24 and March 17, 2009, from Mississippi Area 2C, located in the Mississippi Sound portion of the Gulf of Mexico near Pass Christian, Miss. Further, consumers are advised not to eat such oysters. Consumers who are uncertain about the origin of oysters they currently have should contact the place of purchase to determine if the oysters are from the affected area as the Agency investigates an outbreak of norovirus illnesses associated with the oysters. Norovirus is a foodborne pathogen that can cause acute gastroenteritis in humans.
CPSC Warns of Deadly Fire and Carbon Monoxide Hazards with Winter Home Heating
January 27, 2009
FDA notified consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement but containing sibutramine, an undeclared drug product and a controlled substance with risks for abuse or addiction. When present in a dietary supplement, it may harm unsuspecting consumers because sibutramine can substantially increase blood pressure and heart rate, and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats or stroke. The product was sold via distributors and in retail stores nationwide and was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743.Consumers who have this product should stop taking it immediatelyand contact their health care professional if they have experienced any adverse effects.
Read the MedWatch 2009 safety summary, including a link to the FDA News Release, at:
FDA issued a public health advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from mammography and other medical tests and conditions. FDA is concerned about the potential for these products to cause serious, life-threatening adverse effects, such as irregular heartbeat, seizures, breathing difficulties, coma and even death, when applied to a large area of skin or when the area of application is covered. FDA is working with healthcare professional organizations and other media that distribute healthcare information to spread the message about the potential hazards and safe use of topical anesthetics. The Advisory and the Dear Colleague letter provide recommendations to both doctors and patients on safe use of these products.
Kellogg Company today announced it has taken the precautionary measure of putting a hold on Austin and Keebler branded Toasted Peanut Butter Sandwich Crackers, Peanut Butter and Jelly Sandwich Crackers, Cheese and Peanut Butter Sandwich Crackers, and Peanut Butter-Chocolate Sandwich Crackers.
November 17, 2008
Beware of Extortion Scam by FDA Impersonators
As part of a fraudulent scheme to extort money, callers have falsely identified themselves as "FDA special agents" or other FDA officials.
November 14, 2008
Seattle's Favorite Gourmet Cookies and Dessert Co Issues Nationwide Allergy Alert on Undeclared Milk in Muffin Tops
Seattle's Favorite Gourmet Cookies and Dessert Co. is recalling Orange Cranberry and Banana Nut Muffin Tops because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume these products.
October 29, 2008
Mexican Vanilla With Coumarin: No Bargain
Beware of Mexican vanilla that contains coumarin, a toxic substance banned in the United States.
October 28, 2008
FDA Warns Bayer About Two Unapproved Aspirin Products
FDA has sent warning letters to Bayer HealthCare regarding two over-the-counter products that combine aspirin with a dietary supplement into a single pill.
October 8,2008
FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children
Background: The Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the-counter (OTC) cough and cold medicines in children, recently announced that its members are voluntarily modifying the product labels for consumers of OTC cough and cold medicines to state "do not use" in children under 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.
The U.S. Food and Drug Administration supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. The FDA continues to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines. Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating "do not use in children under 4," which reflects a more restrictive use of the drugs in children.
The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist.
Over the last year, FDA has been working on several fronts to address the safe use of nonprescription OTC cough and cold medicines in children.
FDA has held two public meetings to hear from stakeholders and consumers on the issue, most recently, a public hearing that focused on labeling of these products on Oct. 2, 2008. In January of this year, FDA issued a nationwide Public Health Advisory recommending that these products not be used in children under the age of two because of the risk of serious and potentially life-threatening side effects.
Another part of the agency's work includes outreach to other public health agencies, consumer and patient groups companies that manufacture these products, and CHPA.
FDA will continue to work with the Centers for Disease Control and Prevention to monitor the ongoing use of these products and to develop educational materials for parents and consumers. The Agency will also continue to reach out to the scientific community to obtain more up-to-date information and scientific data about the effects of these products in children so that it can take the appropriate regulatory steps moving forward.
All these areas are vital to support the development and review of data regarding the safe and effective use of these products.
FDA is proceeding with its rulemaking process to update the existing OTC monograph for cough and cold products for children, and will consider input from the recent hearing of Oct. 2. The rulemaking process affords additional opportunity for the submission of data and public comment.
Until all these issues are resolved, FDA continues to recommend to parents and caregivers the following:
Do not give children medications labeled only for adults.
Talk to your healthcare professional if you have any questions about using cough or cold medicines in children.
Choose OTC cough and cold medicines with child-resistant safety caps, when available. After each use, make sure to close the cap tightly and store the medicines out of the sight and reach of children.
Check the "active ingredients" section of the DRUG FACTS label of the medicines that you choose. This will help you understand what symptoms the "active ingredients" in the medicine are intended to treat. Cough and cold medicines often have more than one active ingredient (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer).
Be very careful if you are giving more than one medicine to a child. If you are giving more than one medicine to a child make sure that they do not have the same type of "active ingredients." If you use two medicines that have the same or similar active ingredients, a child could get too much of an ingredient and that may hurt your child. For example, do not give a child more than one medicine that has a decongestant.
Carefully follow the directions for how to use the medicine in the DRUG FACTS part of the label. These directions tell you how much medicine to give and how often you can give it. If you have a question about how to use the medicine, ask your pharmacist or your doctor. Overuse or misuse of these products can lead to serious and potentially life threatening side effects such as rapid heartbeat, drowsiness, suppression of the respiratory system, seizures and other adverse events.
Only use measuring devices that come with the medicine or those specially made for measuring drugs. Do not use common household spoons to measure medicines for children because household spoons come in different sizes and are not meant for measuring medicines.
Understand that using OTC cough and cold medicines does not cure the cold or cough. These medicines only treat your child’s symptom(s) such as runny nose, congestion, fever and aches and do not shorten the length of time your child is sick.
October 6, 2008
Melamine Contamination in China
On September 12, 2008, in light of reports from China of infant formula contaminated with melamine, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Asian communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants. No Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States.
The FDA contacted the companies that manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula and do not source milk-based ingredients from China.
In addition, the FDA -– in conjunction with state and local officials – continues to check Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins.
The FDA has broadened its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk or milk-derived ingredients from Chinese sources. FDA has recommended that consumers not consume certain products because of possible contamination with melamine. A list of those products is below.
Update on FDA’s Investigation
October 6, 2008: The FDA has increased inspections and product testing efforts in response to reports of contamination of milk-derived ingredients and finished food products containing milk manufactured in China. As a result of the FDA’s on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA’s findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service.
The FDA is advising consumers not to consume the following products because of possible melamine contamination:
Blue Cat Flavored Drinks
White Rabbit Candies
Mr. Brown Mandheling Blend Instant Coffee (3-in-1)
Mr. Brown Arabica Instant Coffee (3-in-1)
Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
Mr. Brown French Vanilla Instant Coffee (3-in-1)
Mr. Brown Mandhling Blend instant Coffee (2-in-1)
Mr. Brown Milk Tea (3-in-1)
Infant formula manufactured in China
The information on this page was obtained from the FDA. For more information on these and other government warnings, please visit www.fda.gov.
