YOUR SOURCE ON FOOD LITIGATION AND REGULATION

On September 19, the FDA Foods and Veterinary Programs held a webinar to discuss FDA’s recent issuance of the preventive controls hazard analysis and risk-based draft guidance (Draft Guidance), which became available for public comment on August 24, 2016.1 The Draft Guidance provides the first five chapters of a 14-part guidance designed to help businesses comply with the Preventive Controls for Human Food Final Rule2 by the compliance date of September 19, 2016.

The Draft Guidance explains FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls, and includes discussions on establishing a food safety plan, what a hazard analysis entails, appropriate preventive controls for certain food categories, monitoring, corrective actions based on a hazard analysis, verification, and records requirements.

FDA recently released an updated version of its draft guidance on new dietary ingredients (NDIs), Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.1 The lengthy draft guidance details FDA’s thinking on determining whether an NDI notification is required, including how to determine if a substance is an NDI, exceptions to the notification requirement, NDI notification procedures and timeframes, what to include in an NDI notification, and a decision tree for NDI notification that helps companies determine whether an ingredient is an NDI and if notification is necessary.

A “dietary ingredient” is an ingredient used in a dietary supplement. NDIs are a subset of dietary ingredients that were not in the US food supply as dietary ingredients before October 15, 1994. The new draft guidance represents the FDA’s current thinking on NDIs and amends and supersedes the original 2011 draft guidance.

On August 24, the US Food and Drug Administration (FDA or Agency) issued a final rule (Final Rule) that extends and clarifies the compliance dates for a limited subset of Food Safety Modernization Act (FSMA) requirements in four of the seven foundational rules part of FDA’s FSMA implementation.1 The four rules include

  • Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (Preventive Control Rules) for Human and Animal Foods;2
  • Foreign Supplier Verification Programs (FSVP);3 and
  • Produce Safety.4

On July 29, US President Barack Obama signed legislation that establishes a national disclosure requirement for identifying bioengineered foods and food ingredients, known colloquially as “GMO” (genetically modified organism) or “GE” (genetically engineered) foods. The disclosure requirement will apply to foods subject to labeling requirements under the Federal Food, Drug, and Cosmetic Act. Please see our LawFlash, New GMO Legislation Signed Into Law, for more information.

On July 14, FDA issued a final rule amending the requirements for the registration of food facilities (Final Rule).1 The Final Rule was issued as part of the implementation of the Food Safety Modernization Act (FSMA) to help improve the accuracy of the food facility registration database.

Background of FSMA

FSMA, enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances.

On June 1, FDA issued draft guidance for voluntary sodium reduction goals for food manufacturers and restaurants.1 According to the guidance, approximately three-quarters of sodium consumed by the US population is added during food manufacturing and commercial food preparation. The new goals are therefore intended to encourage food manufacturers, restaurants, and food service operations to reduce the amount of sodium they add to food to reduce overall salt consumption by about 50% throughout the next 10 years.

FDA states in the guidance that Americans consume too much sodium, and broad sodium reductions are necessary to achieve health benefits. The average sodium intake in the US is approximately 3,400 mg/day, about 50% more than the 2,300 mg/day recommended in the 2015-2020 Dietary Guidelines for Americans. According to FDA, a diet high in sodium contributes to the development of hypertension, a leading cause of heart disease and stroke. Excessive sodium intake has also been linked to high blood pressure, another risk factor for heart disease and stroke.

On May 27, the US Food and Drug Administration (FDA or Agency) published a final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (Final Rule).1 The Final Rule is part of FDA’s implementation of the Food Safety Modernization Act (FSMA) and requires food facilities to prepare and implement a food defense plan, conduct a vulnerability assessment, and implement mitigation strategies with food defense monitoring procedures to minimize or prevent significant vulnerabilities.

The Final Rule applies to both domestic and foreign facilities required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is targeting larger businesses with this Final Rule because its purpose is to protect the food supply against individuals or organizations with intent to cause large-scale public health harm.

On May 13, FDA announced the publication of a draft guidance to assist “qualified facilities” (i.e., very small or low-grossing businesses) in complying with the Preventive Controls for Human or Animal Food Rules (PC Final Rules) under the FDA Food Safety Modernization Act (FSMA) (Draft Guidance). 1,2

On May 10, FDA announced that it will reevaluate regulations concerning nutrient content claims (NCCs), including the definition of “healthy.”

An NCC is a claim on a food product label that directly or by implication characterizes the level of a nutrient in a food (e.g., “low fat,” “high in fiber,” “healthy”). A food with a “healthy” NCC claim must contain specific low levels of total fat, saturated fat, cholesterol, and other nutrients. However, members of the food industry have pointed to current nutrition guidance that state that a healthy diet includes foods that are high in certain fats, such as almonds, avocados, and salmon.

If you have been down a pet food aisle recently, you may have noticed dog and cat foods that claim to treat various conditions, making claims to treat urinary tract disease in cats or “control blood glucose” in dogs. Products with these types of claims have been marketed for more than 50 years; however, because of the potential for consumers to misuse or misunderstand these products as effective treatments for disease conditions in pets, the FDA’s Center for Veterinary Medicine (CVM) recently outlined its policies for enforcement on the topic of disease claims in dog and cat foods.

On April 29, 2016, CVM released Compliance Policy Guide (CPG) 690.150: Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases.1 The CPG describes situations when CVM intends to take enforcement action against dog and cat foods that are labeled as intended to diagnose, cure, mitigate, treat, or prevent diseases (disease claims). These products may be regulated as a food, drug, or both. A product is an animal drug if it makes disease claims, and otherwise is an animal food.