CPSC Approves Final Rule on Guidelines for Mandatory Recall Notices
CPSC Approves Final Rule on Guidelines for Mandatory Recall Notices
House Approves New Food-Safety Laws
House Approves New Food-Safety Laws - NYTimes.com
In a step toward a major overhaul of the nation’s food-safety system, the House on Thursday passed legislation to require more frequent inspections of food-processing plants and to give the government the authority to order the recall of tainted foods.
Cheerios’ Health Claims Break Rules, FDA Says. Should file application as a drug.
The Food and Drug Administration slapped General Mills Inc. with a warning over its Cheerios cereal, saying the box’s claims about heart benefits contain “serious violations” of federal law.
In a May 5 warning letter sent to the company ( posted below and on the FDA’s Web site Tuesday) the agency said statements that the product is “clinically proven to help lower cholesterol” make the product a drug under federal law.
It appears that the FDA takes issue with the violations caused by labeling and mis-branding, rather than the veracity of the claims themselves.
A copy of the letter follows:
|
Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7114 FAX: (612) 3344142 |
Department of Health and Human Services
May 5,2009
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 09 -18
Ken Powell
Chairman of the Board and CEO
General Mills
One General Mills Boulevard
Minneapolis, Minnesota 55426
Dear Mr. Powell:
The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA’s review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA’s home page at http://www.fda.gov.
Unapproved New Drug
Based on claims made on your product’s label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims ort its label:
• “you can Lower Your Cholesterol 4% in 6 weeks” ”
• “Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is … clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”
These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and “bad” (LDL) cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application.
FDA has issued a regulation authorizing a health claim associating soluble fiber from whole grain oats with a reduced risk of coronary heart disease (21 CFR 101.81). Like FDA’s other regulations authorizing health Claims about a food substance and reduced risk of coronary heart disease, this regulation provides for the claim to include an optional statement, as part of the health claim, that the substance reduces the risk of coronary heart disease through the intermediate link of lowering blood total and LDL cholesterol. See 21 CFR 101.81(d)(2),-(3). Although the lower left corner of the Cheerios® front label contains a soluble fiber/coronary heart disease health claim authorized under 21 CFR 101.81, the two claims about lowering cholesterol are not made as part of that claim but rather are presented as separate, stand-alone claims through their location on the package and other label design features. The cholesterol claim that mentions the clinical study is on the back of the Cheerios® box, completely separate from the health claim on the front label. Although the other cholesterol claim is on the same panel as the authorized health claim, its prominent placement on a banner in the center of the front label, together with its much larger font size, different background, and other text effects, clearly distinguish it from the health claim in the lower left corner.
Additionally, even if the cholesterol-lowering claims were part of an otherwise permissible claim, under 21 CFR 101.81, the resulting claim language still would not qualify for the use of the soluble fiber health claim. To use the soluble fiber health claim, a product must comply with the claim specific requirements in 21 CFR 101.81, including the requirement that the claim not attribute any degree of risk reduction for coronary heart disease to diets that include foods eligible to bear the claim. See 21 CFR 101.81(c)(2)(E). However, the label of your Cheerios® cereal claims a degree of risk reduction for coronary heart disease by stating that Cheerios® can lower cholesterol by four percent in six weeks. High blood total and LDL cholesterol levels are a surrogate endpoint for coronary heart disease; therefore, the cholesterol-lowering claims on the Cheerios® label attribute a degree of risk reduction for coronary heart disease because if total and LDL cholesterol levels decline, the risk of coronary heart disease declines as well.
Misbranded Food:
Your Cheerios ® product is misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] because it bears unauthorized health claims in its labeling. We have determined that your website www.wholegrainnation.com is labeling for your Cheerios® product under section 201(m) of the Act [21 U.S.C. § 321 (m)] because the website address appears on the product label. This website bears the following unauthorized health claims:
- “Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease.”
This health claims misbrands your product because it has been authorized either by regulation [see section 343(r)(3)(A)-(B) of the Act [21 U.S.C. § 343(r)(3)(A)(B)]] or under authority of the health claim notificati6n provision of the Act [see section'343(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(G)]]. Although FDA has issued a regulation authorizing a health claim associating fiber-containing grain products with a reduced risk of coronary heart disease (21 CFR 101.77), the claim on your website does not meet the requirements for this claim. For example, under section 101.77(c)(2), the claim must state that diets low in saturated fat and cholesterol and high in fiber-containing fruit, vegetable, and grain products may reduce the risk of heart disease. The claim on your website leaves out any reference to fruits and vegetables, to fiber content, and to keeping the levels of saturated fat and cholesterol in the diet low. Therefore, your claim does not convey that all these factors together help to reduce the risk of heart disease and does not enable the public to understand the significance of the claim in the context of the total daily diet (see section 343(r)(3)(B)(iii) of the Act [21 U.S.C.§ 343(r)(3)(B)(iiill].
In addition to the health claim authorized by regulation in 21 CFR 101.77, other health claims linking the consumption of whole grain foods to a reduced risk of heart disease have been authorized through the notification procedure in section 403(r)(3)(C) of the Act. Of those authorized claims, the one closest to the claim on your website states: “Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease.1” Although the claim on your website also concerns whole grains and reduced risk of heart disease, it is different from the authorized claim in significant ways. To meet the requirements of the authorized claim, the claim must state that diets that are (1) rich in Whole grains and other plant foods, and (2) low in saturated fat and cholesterol will help reduce the risk of heart disease) Instead, the claim on your website only states that diets rich in whole grains can reduce the risk of heart disease, with no mention of other plant foods or of low saturated fat and cholesterol.
- “Including whole grain as part of a healthy diet may … [h]elp reduce the risk of certain types of cancers. Regular consumption of whole grains as part of, a low-fat diet reduces the risk for some cancers, especially cancers of the stomach and colon.”
This health claim misbrands your product because it has not been authorized either by regulation [see section 343(r)(3)(A)-(B) of the Act [21 U.S.C. § 343(r)(3)(A)(B)]] or under authority of the health claim notification provision of the Act [see section 343(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)]]. Although FDA has issued a regulation authorizing a health claim associating fiber-containing grain products with a reduced risk of cancer (21 CFR 101.76), the claim on your website does not meet the requirements for the authorized claim.For example, under section 101.76(c)(2) the claim must state that diets high in fiber-containing grain products, fruits, and vegetables may reduce the risk of some cancers. The claim on your website leaves out any reference to fruits, vegetables, and fiber content. Therefore, your claim does not convey that all these factors together help to reduce the risk of heart disease and does not enable the public to understand the significance of the claim in the context of the total daily diet [see section 343(r)(3)(B)(iii) of the Act [21 U.S.C. § 343(r)(3)(B)(iii)]].
In addition to the health claim authorized by regulation in 21 CFR 101.76, a health claim linking the consumption of whole grain foods to a reduced risk of certain cancers has been authorized through the notification procedure in section 403(r)(3)(C) of the Act. The authorized claim is: “Diets rich in whole grain foods and other plant foods … may help reduce the risk of… certain cancers.”2 Although the claim on your website also concerns whole grains and reduced risk of some cancers, it is different from the authorized claim in significant ways. For example, the authorized claim states that diets rich in whole grain foods and “other plant foods” may help reduce the risk for certain cancers. However,the claim on your website does not mention “other plant foods.” Also, by using the language “especially cancers of the stomach and colon” the claim on your website emphasizes the relationship between whole grain foods and stomach and colon cancers as compared to other cancers, suggesting a greater degree of risk reduction or stronger evidence for the relationship between whole grain foods and risk of those two cancers. The claim authorized through the notification procedure does not emphasize the relationship between whole grain foods and stomach and colon cancer as compared to other cancers.
This letter is not intended to be an all-inclusive review of your products and their labeling. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
Please advise this office in writing 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
Please send your reply to the attention of Tyra S. Wisecup, Compliance Officer, at the address in the letterhead. If you have any questions regarding this letter, please contact Ms. Wisecup at (612) 758-7114.
Sincerely,
/s/
W. Charles Becoat
Director
Minneapolis District
TSW/cd
1 See “Health Claim Notification for Whole Grain Foods with Moderate Fat Content,” December 9, 2003 (http://www.cfsan.fda.gov/~dms/f1grain2.html).
2 See “Health Claim Notification for Whole Grain Foods,” July 1999 (http://www.cfsan.fda.gov/-dms/flgrain2.html).
President Plans Team to Overhaul Food Safety - NYTimes.com
President Plans Team to Overhaul Food Safety - NYTimes.com
Describing the government’s failure to inspect 95 percent of food processing plants as “a hazard to the public health,” President Obama promised Saturday to bolster and reorganize the nation’s fractured food-safety system.
Each year, about 76 million people in the United States are sickened by contaminated food, hundreds of thousands are hospitalized and about 5,000 die, public health experts estimate.
The Obama administration’s 2010 budget will propose spending more than $1 billion on food-safety efforts, nearly double the amount spent in 2007. The money will pay for increased inspections, domestic surveillance, laboratory capacity and illness prevention efforts.
The F.D.A. has estimated that inspecting all 150,000 domestic food facilities once every four years would cost $1.9 billion annually. Inspecting the 216,000 foreign food plants registered with the F.D.A. would cost far more.
Food Safety Proposal Empowers US to Force Recalls
Bloomberg.com: Worldwide
March 3 Bloomberg — Food-safety legislation introduced in the Senate today would give the U.S. Food and Drug Administration new power to order recalls and open companies’ internal records for inspection.
Senators Richard Durbin, Democrat of Illinois, and Judd Gregg, Republican of New Hampshire, sponsored the measure, the first since President Barack Obama offered a budget proposal last week allocating $1 billion to strengthen food safety.
CPSC Grants One Year Stay of Testing and Certification Requirements for Certain Products
CPSC Grants One Year Stay of Testing and Certification Requirements for Certain Products
The U.S. Consumer Product Safety Commission voted unanimously 2-0 to issue a one year stay of enforcement for certain testing and certification requirements for manufacturers and importers of regulated products, including products intended for children 12 years old and younger. These requirements are part of the Consumer Product Safety Improvement Act CPSIA, which added certification and testing requirements for all products subject to CPSC standards or bans.
Significant to makers of children’s products, the vote by the Commission provides limited relief from the testing and certification requirements which go into effect on February 10, 2009 for new total lead content limits 600 ppm, phthalates limits for certain products 1000 ppm, and mandatory toy standards, among other things. Manufacturers and importers – large and small – of children’s products will not need to test or certify to these new requirements, but will need to meet the lead and phthalates limits, mandatory toy standards and other requirements.
Peanut Recall Leads to Criminal Investigation - NYTimes.com
Peanut Recall Leads to Criminal Investigation - NYTimes.com
Federal health officials have begun a criminal investigation into the actions of the Peanut Corporation of America, which knowingly sold contaminated peanut butter and peanut products to major food makers.
California Is First State to Ban Trans Fats, Starts in 2010
California Is First State to Ban Trans Fats - NYTimes.com
LOS ANGELES — California became the first state in the nation to place a ban on trans fats in restaurants and retail baked goods Friday when Gov. Arnold Schwarzenegger signed a bill to phase out their use over the next few years. Under the new law, the artificial fats must be excised from restaurants beginning in 2010, and from all retail baked goods by 2011.
Brown introduces potentially historic food recall bill
Brown introduces potentially historic food recall bill
United States Senator Sherrod Brown (D-OH) today announced his introduction of the Safe and Fair Enforcement and Recall for (SAFER) Meat, Poultry, and Food Act that would give federal authorities new power to issue mandatory recalls of tainted food items. The announcement comes on the heels of recent E. coli outbreaks in Ohio and Michigan.
Understanding the Use of Lead in Consumer Products
CPSC Staff Roundtable: Understanding the Pending Lead Legislation and the Use of Lead in Consumer Products, May 13, 2008
The U.S. Consumer Product Safety Commission CPSC staff held a one-day roundtable, “Understanding the Pending Lead Legislation and the Use of Lead in Consumer Products” on May 13, 2008. This roundtable was intended to provide stakeholders with an understanding of the pending Congressional action on lead and the use of lead in consumer products, especially children’s products.
CPSC staff discussed pending lead legislation and enforcement issues, current events abroad, and laboratory testing procedures for lead. Industry representatives discussed the use of lead in consumer products for example, paints and coatings, toys, plastics, jewelry, electronics, batteries and textiles, potential substitutes for lead in their products, best practices that can be implemented to eliminate or reduce the use of lead, and differences between domestic manufacturing plants and their practices and those outside the U.S. The roundtable included question and answer sessions and discussions led by the CPSC staff. A wrap-up session for final comments and questions and answers concluded the day.