New Gluten-Free Standards Highlight Triumphs and Challenges at the FDA

by Sam Abbott, 8/5/2013

Last Friday, the Food and Drug Administration (FDA) released final standards that manufacturers must meet before labeling their food products “gluten free.” According to the new rules, a food product must contain less than 20 parts per million (ppm) of gluten before a producer can label and advertise the product as being without gluten. These new standards will allow the 2 million Americans who suffer from celiac disease more confidence and certainty in purchasing products that are safe for them to consume. The new rules also legitimize a growing “gluten-free” foods industry that is expected to be worth more than $6.6 billion by 2017.

The new rules come nine years after Congress directed the FDA to set these standards with the Food Allergen Labeling and Consumer Protection Act and three years after the statutory deadline. The FDA first proposed the rule in 2007 and then spent the next six years reviewing scientific evidence and soliciting two rounds of stakeholder comments. 

In February of this year, the final rule was sent for review at the Office of Information and Regulatory Affairs (OIRA), where it sat for 156 days, 36 days over the maximum allowed by Executive Order 12866.  Such delays and “paralysis by analysis” have become a common and unfortunate story about federal rulemaking. While the FDA’s new “gluten-free” standards are a positive step forward in expanding consumer information and safety, they are emblematic of broader challenges the FDA faces in its foods safety program.

Setting standards for “gluten-free” products is just a small portion of the food safety initiatives that have kept the FDA busy. The Food Safety Modernization Act of 2011 (FSMA), the most extensive reform of food safety laws in over 70 years, greatly expanded the FDA’s authority to oversee safety in all levels of food production and shifted agency focus toward preventing food-borne illnesses, rather than reacting to outbreaks after they have already occurred.

So far, the agency has missed many of the rulemaking deadlines set by the FSMA, leaving Americans exposed to unnecessary illnesses that cost the economy $78 billion every year in medical treatment and lost wages. However, these delays are not entirely the FDA’s fault. For several years, the White House has requested an increase of approximately $500 million in the FDA’s budget to enable it to enact its new food safety responsibilities, but Congress has kept funding levels relatively flat. This year, the House appropriations bill, H.R. 2410: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, cut over $228 million from the president’s budget for the Center for Food Safety and Applied Nutrition, which is responsible for writing and enforcing safeguards for domestically produced and imported food products. If the cuts became law, they would make it nearly impossible for the agency to modernize food safety in accordance with the law.

The FDA’s new gluten-free standards are certainly welcome, but we are still waiting for stronger protections from food-borne pathogens like E. coli, Salmonella, and parasites, all of which have been identified as sources for food contamination outbreaks within just the last ten days. These pathogens affect a much larger portion of the food supply. Extensive delays by the White House and grossly inadequate funding by Congress are preventing the FDA from creating and enforcing the safeguards that protect us from deadly foodborne illnesses.

The White House and Congress took an important step forward in food safety in 2011 by passing the Food Safety Modernization Act.  Now they need to grant the FDA the necessary resources to actually implement the law and protect Americans from devastating and unnecessary illnesses.  

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