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Regulatory Issues

FDA Listens to Raw Milk Cheese Producers

Following the release of a surprise statement by the U.S. Food and Drug Administration (FDA) expressing respect for the artisan cheesemaking community and announcing that FDA is “pausing its testing program for non-toxigenic E. coli in cheese,” FDA Deputy Director for Foods and Veterinary Medicine, Michael Taylor, met with raw milk cheese producers on February 12 to learn more about the concerns of the American artisan cheese industry.

This Listening Session was held at FDA’s Center for Food Safety and Applied Nutrition, where Taylor was joined by Dr. Susan Mayne, Director of the Center for Food Safety and Applied Nutrition, and a number of pertinent FDA staff. In opening remarks, American Cheese Society (ACS) Executive Director, Nora Weiser, expressed that “ACS’s desire to preserve and protect traditional cheesemaking practices; ensure safe, diverse products for consumers; and work with regulators to avoid undue and unnecessary barriers to growth are shared by many allied industry groups.” Weiser went on to name over 20 industry groups that support ACS in this direction, including numerous regional cheese guilds, international cheese organizations, and other dairy industry groups.

Seven ACS members, all raw milk cheesemakers from around the country, lent their voices to advance the dialogue and understanding that are needed to ensure continued growth of the artisan cheese sector. Presenting cheesemakers focused on several key issues:

  • A need for transparency in rule-making, including the process that leads to policy change, as well as discussion with stakeholders to understand real-world implications early in the rule-making process
  • Collaborative engagement between regulators and cheesemakers including sharing of best practices, data, and science-based information
  • Concern over the uncertain climate for raw milk cheesemakers, in particular regarding potential changes to the 60-day aging rule for raw milk cheeses
  • Building trust after years of interactions that focused on enforcement of rules rather than enhancement of safety outcomes
  • Impact of the Food Safety Modernization Act (FSMA) on artisan, farmstead, and specialty cheesemakers
  • Recognition of the value and visibility of specialty cheese among consumers; its importance in strengthening rural economies; and its role in growing the entire dairy and cheese sector.

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Taylor emphasized that “we have to work together, and ACS is positioned for leadership in helping FDA understand what works for your product.” He went on to explain that preventive controls (PC) are about industry knowing what is needed and assessing what history has shown is successful. In response to ongoing concerns over changes to the 60-day aging rule, Taylor assured the group that any change to the rule will not be a surprise to stakeholders, and that this open dialogue is a prelude to any future rule-making or comment process. He stated that we must “look at raw milk cheese in [the] context of the PC framework.”

Mayne agreed, stressing the importance of science. She pledged that FDA will seek outside consult from academia and science in approaching artisan cheese safety. She sees moving forward in three steps: dialogue, which was furthered at the Listening Session; data, which must be shared openly; and scientific engagement, with technical discussions informed by what cheesemakers are doing.

Spurred by Taylor and Mayne, those present agreed that the next step is to pull together a group of relevant stakeholders, technical experts, and appropriate FDA staff to convene and discuss what preventive controls might look like for raw milk cheesemaking, and how testing can play its appropriate role in verifying controls. Jeremy Stephenson, cheesemaker at Spring Brook Farm in Vermont and member of the ACS Board of Directors, captured the theme of the meeting when he stated, “Concrete, measurable steps need to be taken on the part of FDA at every level to give the cheesemaking community confidence that regulators are operating in the spirit of FSMA. We need and value good regulation both to protect our customers as well as our collective industry.”

House Votes to Ease FDA Menu Labeling Rules for Supermarkets

Food Marketing Institute (FMI) commended the U.S. House of Representatives for approving on a bipartisan basis (266-144-1) legislation that offers workable solutions to fix flaws contained in the Food and Drug Administration’s (FDA) final chain restaurant menu labeling regulations that were expanded in 2015 to apply to grocery stores.

FMI President and CEO Leslie G. Sarasin said, “The Common Sense Nutrition Disclosure Act of 2015 (H.R. 2017) is not about being ‘for’ or ‘against’ the inclusion of nutrition information on menus. Instead, the bill injects some common sense into the rule by avoiding a one-size fits all system and allowing supermarkets to provide this important information to their customers in ways that are most accessible and useful to the customers for whom it is intended.”

She continued, “FMI has fervently pursued legislation because FDA has not been able to resolve through regulation the supermarket industry’s recorded concerns and needed clarification. With the quickly approaching deadline for compliance, FMI members desperately need this helpful bi-partisan legislative resolution.”

Importantly, the bill does not exempt supermarkets or any other retailers from the nutrition information requirement.  Instead, it offers practical suggestions for menu labeling regulations in a grocery store setting along with flexible disclosure options. Provisions of the Common Sense Nutrition Disclosure Act of interest to the supermarket industry include:

  • Allowing use of a menu or menu board in a prepared foods area or next to a salad bar instead of requiring individual labeling of every item;
  • Preserving local foods or fresh items that may only be sold at one or two store or restaurant locations;
  • Allowing an establishment to take corrective actions within 90-days prior to federal, state or municipal enforcement and thereby provide some degree of liability protection; and
  • NOT modifying or weakening FDA’s or state officials’ current oversight/enforcement authority.

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Sarasin commented, “We appreciate the support of such an impressive and diverse group of Members of Congress – they are true champions of solving problems for the 1,225 businesses and 40,000 stores FMI represents.”

KIND Asks FDA to Reconsider Label Requirements

 

By Richard Thompson

 

KIND bars are healthy and the Food and Drug Administration should allow the labels to reflect that, according to KIND, LLC. Last year, the FDA sent a warning letter to KIND stating that the company’s labels on four of its products were misleading, resulting in label changes to comply with FDA regulations. In December, though, KIND sent a citizen’s petition to the FDA requesting a new look at how the term “healthy” is defined. While the FDA reviews the company’s request, KIND asserts that by updating the definition of “healthy” to reflect current dietary and nutritional understanding, not only will its products warrant the use of the term, but consumers won’t continue to be confused about what foods are truly healthy to eat.

“Under FDA’s current application of food labeling regulations, whether or not a food can be labeled ‘healthy’ is based on specific nutrient levels in the food rather than its overall nutritional quality,” reads KIND’s citizen petition. “This is despite the fact that current science no longer supports those standards.”

Said Joe Cohen, SVP of Communication at KIND, “We’re proud of the ingredients in our products, which contain wholesome ingredients like fruits, nuts, seeds and whole grains.” He added, “We will continue to work with the FDA to ensure our products are in compliance with the regulations.”

“Without commenting specifically on the KIND citizen petition,” said Doug Balentine, Ph. D., Director of the Office of Nutrition and Food Labeling at the FDA, “The FDA recognizes that a great deal of scientific research has been conducted since the regulation defining the term ‘healthy’ was developed and we understand the interest in potentially redefining the term.” The agency’s ultimate determination will be based on the reevaluation of food labeling terms as additional scientific research and other data becomes available based on public health impact.
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For the last 20 years, the definition of what’s healthy has been changing as more recent research shows that nutritional content is not the only indicator in determining what a healthy food is. Scientific evidence found in the U.S. Government’s “2010 Dietary Guidelines” and the “Scientific Report of the 2015 Dietary Guidelines Advisory Committee” – both of which KIND heavily refers to in its citizen petition – concludes that eating a healthy diet is constituted by the maintenance of caloric intake for a healthy weight and that a healthy eating pattern emphasizes nutrient-dense foods and vegetables like fruit, nuts and whole grains.

According to KIND, the best way to rectify consumers’ confusion over nutritional content and healthful qualities of a product would be to create a dietary guidelines statement on the packaging that informs on the “usefulness of a food, or a category of foods, in maintaining healthy dietary practices” without making an explicit nutrient content claim or a statement about a particular nutrient.

Until a decision is made, KIND says that a “dietary guidance statement” from the FDA is in order so that food companies can better label their products with information that indicates the usefulness of a food “that is not subject to the requirements in FDA’s nutrient content claim regulations unless it is an implied nutrient content claim.”

The FDA appears to disagree, and Balentine said that there is more to labeling restrictions than how one company is affected by them. For now, companies need to continue following the standards laid out by the FDA so that the term means the same thing from product to product. Said Balentine, “That’s the only way that consumers can trust what’s on the label.”