U.S. FOOD & DRUG ADMINISTRATION update

Center for Food Safety and Applied Nutrition

Constituent Update

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FDA Acknowledges Qualified Health Claim Linking Early Peanut Introduction and Reduced Risk of Developing Peanut Allergy

September 7, 2017

After conducting a systematic review of the available scientific evidence, the U.S. Food and Drug Administration has determined that it intends to exercise enforcement discretion for the use of a qualified health claim for infants with severe eczema and/or egg allergy characterizing the relationship between the consumption of foods containing ground peanuts beginning between 4 and 10 months of age and a reduced risk of developing peanut allergy by 5 years of age.

The claim, which manufacturers can use immediately, reads:

For most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age. FDA has determined, however, that the evidence supporting this claim is limited to one study.

If your infant has severe eczema and/or egg allergy, check with your infant’s healthcare provider before feeding foods containing ground peanuts.

The qualified health claim was in response to a petition filed by Assured Bites, Inc. Qualified health claims are not the same as “authorized health claims,” which must be supported by significant scientific agreement among experts in the field. Qualified health claims are supported by credible scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim. As such, they are accompanied by qualifying language or a disclaimer so that the level of scientific evidence supporting the claim is accurately communicated. The FDA’s intent to exercise enforcement discretion for the use of the qualified health claim means that the agency does not intend to object to its use as long as the products bearing the claim are consistent with the factors FDA stated in the Letter of Enforcement Discretion.

Epidemiological evidence suggests that the prevalence of peanut allergy in U.S. children has at least doubled from 1997 to 2008. Peanut allergy is one of the most common food allergies and, in the majority of individuals, it begins early in life and persists throughout life. There are no FDA-approved treatments for preventing or curing peanut allergy, and it is the leading cause of death related to food-induced anaphylaxis in the United States. Thus, interventions that may prevent development of peanut allergy could be beneficial to public health.

Published in 2015, the Learning Early about Peanut Allergy (LEAP) study involving more than 600 infants was the first randomized intervention trial to study early introduction to peanut protein in infants as a preventive strategy. The study demonstrated that for infants with severe eczema and/or egg allergy, a population at high risk of developing peanut allergy, beginning consumption of peanut-containing foods in infancy (between 4 and 10 months of age) reduced the risk of developing peanut allergy by 5 years of age by more than 80 percent. In light of this finding and the public health consequences of peanut allergy, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), established a coordinating committee, which convened an expert panel to develop new clinical recommendations to prevent the development of peanut allergy. The Addendum Guidelines for the Prevention of Peanut Allergy in the United States provide three guidelines for the early introduction of peanut-containing foods in infants, based on their level of risk for developing peanut allergy.

This qualified health claim is supported by the same scientific evidence behind the first Addendum Guideline that recommends the introduction of peanut-containing foods to infants with severe eczema, egg allergy, or both, as early as 4 to 6 months of age to reduce the risk of peanut allergy.

For Additional Information:

• FDA Response to Petition for a Qualified Health Claim for Ground Peanuts and Reduced Risk of Developing Peanut Allergy
• FDA Commissioner Statement
• Questions and Answers: Qualified Health Claims in Food Labeling
• Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
• Qualified Health Claims: Letters of Enforcement Discretion
• 2017 Addendum Guidelines for the Prevention of Peanut Allergy in the United States(NIAID, NIH)

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Additional Updates from the FDA Center for Food Safety and Applied Nutrition

Activase (alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance

AUDIENCE: Pharmacy, Critical Care Medicine

ISSUE: Genentech is voluntarily recalling three lots of Activase (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking.  See press release for affected lots.

The use of impacted Sterile Water for Injection could result in adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic infections. To date, Genentech has not received reports of adverse events associated with use of impacted Sterile Water for Injection.

BACKGROUND: Activase is supplied directly to hospitals and used in a hospital setting. Activase is indicated for treating patients with acute ischemic stroke (AIS), which is caused by a blood clot in the brain’s blood vessels, for treating an acute myocardial infarction (AMI), also known as a heart attack and to break apart an acute massive pulmonary embolism (PE), which is a large blood clot lodged in the blood vessels of the lung. Activase is supplied as a sterile, lyophilized powder in 100 mg vials without vacuum. Each 100 mg Activase vial (58 million IU) is packaged with diluent for reconstitution (100 mL Sterile Water for Injection, USP), and one transfer device: NDC 50242-085-27. The product was distributed nationwide to hospitals.

RECOMMENDATION: Genentech is notifying its distributors and customers by issuing a “Dear Customer” letter and arranging for the return of all recalled products. Healthcare providers that have lots of Activase that have been recalled should stop using the product and should return the affected lots to Genentech.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online:www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

View the MedWatch Safety Alert, including links to the press release, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm575027.htm

Country Fresh Orlando LLC, Recalls Product Because of Possible Health Risk

09/05/2017 11:40 AM EDT

Country Fresh Orlando, LLC. of Orlando, Florida, is recalling 5,999 cases of diced bell pepper, vegetable kabobs, and creole and fajita mixed diced vegetables (product descriptions attached), because they have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase® (Alteplase)-100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection

09/06/2017 09:47 PM EDT

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is voluntarily recalling three lots of Activase® (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Country Fresh Orlando LLC, Recalls Product Because of Possible Health Risk

09/05/2017 11:40 AM EDT

Country Fresh Orlando, LLC. of Orlando, Florida, is recalling 5,999 cases of diced bell pepper, vegetable kabobs, and creole and fajita mixed diced vegetables (product descriptions attached), because they have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.