FDA Finalizes Preventative Controls Rules Under FSMA

FDA has finalized preventative controls rules for animal and human foods under the 2011 Food Safety Modernization Act (FSMA).

The development, announced last week and coming more than 4 years after President Obama signed the sweeping food-safety legislation into law, “sets us on the path to a modern food safety system that will prevent illnesses and continue to build confidence in the safety of the food served to our families every day," said Stephen Ostroff, M.D., acting FDA commissioner in a Sept. 10 press release.

Under the preventative controls rules, which were scheduled to be published in the Federal Register on Sept. 17, animal and human food facilities must develop and implement plans that identify potential food-safety hazards and outline steps to prevent or greatly minimize the chance that a food-safety problem will arise, according to FDA.

The two rules are part of seven FSMA rules that FDA plans to finalize by 2016.

“We’ve been working with states, food companies, farmers and consumers to create smart, practical and meaningful rules," said Michael R. Taylor, FDA’s deputy commissioner for foods and veterinary medicine, in the press release. “And we have made a firm commitment to provide guidance, technical assistance and training to advance a food safety culture that puts prevention first."

The preventative controls regulations cover registered food facilities, and food lawyers said before the final rule was published that dietary ingredient suppliers would be subject to the requirements.

FDA was asked to provide examples of the definition of food in the final rule, “particularly dietary supplements and dietary ingredients," but the agency declined to do so.

“Dietary supplements and dietary ingredients are articles used for food or drink for man, as are many other articles," FDA explained in the final rule. “There are many examples of food and adding a limited list of examples could be confusing rather than helpful."

Very small businesses that are not exempt from the requirements have three years to comply with the regulations, small firms have two years, and others have one year after the rule is published in the Federal Register.

FDA estimates the annual costs of compliance is $381 million, but that is a pittance compared to the cost of foodborne illness.

“We estimate that processed foods covered by this rulemaking are responsible for approximately 903,000 foodborne illnesses each year, at a total cost to the American public of approximately $2.2 billion," FDA noted in the final rule.

In May, the Organic & Natural Health Association (ONHA) filed a citizen petition, requesting that FDA subject suppliers of dietary ingredients to cGMPs (current Good Manufacturing Practices) governing supplements.

“Under the existing regulations, dietary ingredient suppliers have no regulatory obligation to manufacture or hold dietary ingredients in accordance with the specific production and process controls that are necessary to ensure finished product quality, and absent contractual obligations, dietary supplement manufacturers and consumers have no recourse against such suppliers that fail to manufacture quality product," Todd Harrison, counsel to ONHA and the organization’s president, wrote in the petition.

Daniel Fabricant, executive director and CEO of the Natural Products Association (NPA), Ph.D., questioned the timing of the citizen petition considering the preventative controls regulations under FSMA had not even been finalized at the time the petition was filed. Several years ago, FDA had considered subjecting ingredient suppliers to its cGMPs (current Good Manufacturing Practices) governing dietary supplements, but the agency declined to do so in the final cGMP rule that was adopted in 2007.

But attorneys general and others this year have questioned whether FDA exerts adequate oversight over the entire supply chain in the supplement industry. 

“At this time, despite the support of coalition of Attorneys General, and an enthusiastic response from many ingredient suppliers, the agency has not taken any action," said Karen Howard, executive director and CEO of the Organic & Natural Health Association.