BakerHostetler FDA and Pharmacy Weekly Digest - November 12, 2018

Alerts / November 12, 2018
Food/Dietary Supplements

FDA Releases Report on Food-borne Illness – The FDA issued a report on the prevalence of food-borne illness risk factors in fast-food and full-service restaurants. The results are part of the first phase of a 10-year study on the issue. The study analyzes the food safety practices and behaviors that contribute to food-borne illnesses in these industries.

FDA Issues Q&A Guidance on Nutrition Labeling – This draft guidance is intended to cover conventional foods and dietary supplements. This guidance addresses questions about two final rules previously issued by FDA – “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” and “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.” Q&As include the definition of serving size, discussion of common household units, the definition of single-serving container and discussion of the reference amount customarily consumed (RACC).

FDA Announces FSMA Guidance – The FDA issued a Q&A final guidance on mandatory food recalls under the Food Safety Modernization Act (FSMA). The guidance addresses the foods that are subject to the mandatory recall authority, the responsible party under FSMA and the process for a mandatory recall. The guidance also covers circumstances in which the FDA may decide to move forward with a mandatory recall.

Pet Food Recall – A Missouri company issued a voluntary recall for a formula of dog food due to elevated levels of vitamin D after receiving complaints from several pet owners.

FDA Investigates Cake Mix Company – The FDA and CDC opened an investigation of a cake mix manufacturer related to Salmonella Agbeni illnesses after the manufacturer issued a voluntary recall. Using whole genome sequencing, the agencies were able to link the strain of salmonella to samples taken from the manufacturer’s products.


FDA Announces Strengthened Oversight and Reporting of Inspections – FDA Commissioner Gottlieb announced new steps to enhance oversight and reporting of inspections for sterile injectable drugs. Commissioner Gottlieb indicated that “[m]anufacturing inspections are one of the FDA’s most important tools for ensuring the quality of pharmaceutical products used by American patients. Inspections help us to identify manufacturing issues that could pose potential risks to patients, or problems that could contribute to drug shortages, enabling us to engage manufacturers to address and resolve issues.” The New Inspection Protocol Project (NIPP) “uses standardized electronic inspection protocols to collect data in a structured manner for more consistent oversight of facilities and faster and more efficient analysis of our findings.” The FDA started this initiative using a number of pilot programs and plans to fully implement the program within the next two years.

FDA Releases Guidance on Hepatitis B – The FDA draft guidance is “to assist sponsors in the clinical development of drugs and biologics for the treatment of chronic hepatitis B virus (HBV) infection from the initial investigational new drug application (IND) through the new drug application (NDA)/biologics license application (BLA) and postmarketing phases.”

FDA Signs MOU With DoD – The FDA and the Department of Defense’s Office of Health Affairs announced the finalization of a Memorandum of Understanding “to foster and prioritize the efficient development of safe and effective medical products intended to save the lives of American service members.”

Medical Devices

FDA Classifies Certain Devices – The FDA issued two final orders classifying the insulin therapy adjustment device and the meprobamate test system into Class II (special controls) medical devices.

FDA Updates UDI Compliance Policy – The FDA issued compliance policy guidance related to unique device identification (UDI) for medical devices. The guidance covers enforcement of the UDI requirements for Class I and unclassified devices. The guidance is effective as of Nov. 5, 2018, and supersedes the “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Immediately in Effect Guidance for Industry and Food and Drug Administration Staff,” issued Jan. 16, 2018.


FDA Solicits Comments on Cosmetics – The FDA is requesting public comment on its survey titled “Web-based Pilot Survey to Assess Allergy to Cosmetics in the United States.” The FDA is interested in collecting information on the impact of allergens on consumer use of cosmetics. The information will be gathered via a web-based survey and will access the prevalence of adverse reactions to cosmetics. The comment period closes on Jan. 7, 2019.


FDA to Hold Hearing on Youth E-cigarette Usage – On Dec. 5, 2018, the FDA will hold a public hearing “to discuss its efforts to eliminate youth electronic cigarette (e-cigarette) use as well as other tobacco product use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies.” Registration is open until Nov. 23, 2018. The FDA is also expected to announce a number of new restrictions on flavored e-cigarette products in the coming weeks.

HHS Announces Support for E-cigarette Research – HHS announced its support for research in the e-cigarette space along with a coalition of other health agencies, including a number of new grants focused on issues such as the impact of e-cigarettes on the lungs of young people and the effects of e-cigarette usage on the heart.

Recently Posted Warning Letter

The FDA issued a warning letter to a drug company for failing to properly list its product and to two compounding businesses: one that failed to take sufficient corrective actions after an inspection in which the FDA found numerous deficiencies in the entity’s compounding operations and another that failed to meet the conditions of 503A.


FDA to Hold Public Meeting on Drug Shortages – On Nov. 27, 2018, the FDA and the Center for Health Policy at Duke University will host a public meeting on drug shortages as part of the Agency’s Drug Shortage Task Force. Topics include addressing the root causes of drug shortages and discussion of potential long-term solutions. The FDA also opened a public docket on the topic which will remain open until Jan. 11, 2019.

Authorship Credit: Lindsay P. Holmes

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