From FDA Ombudsman to EAS Consultant

Every Center in FDA, except CFSAN, has an Ombudsman; there is also an Ombudsman in the Office of the Commissioner. I am the only person to have served as the Ombudsman in two different Centers: the Center for Tobacco Products (CTP) for three years and the Center for Devices and Radiological Health (CDRH) for ten years, working in the Office of the Center Director in each position.

An FDA Ombudsman investigates external complaints about the agency; negotiates, mediates or otherwise facilitates the resolution of disputes between FDA and regulated companies; and responds to inquiries from stakeholders who have been unable to get answers elsewhere in FDA.

An Ombudsman, accessible to regulated industry, eases their way to being heard; listens to their issues and concerns; informs them of the regulatory process; and strategizes with them on options to challenge or appeal a decision. Often an Ombudsman is the catalyst that results in an equitable solution to a problem.

I think that having been an Ombudsman at FDA is the perfect segue to being a consultant to companies regulated by FDA. Both roles involve advocating for fairness on behalf of industry; fostering meaningful engagement with the agency; and providing information and assistance to companies in resolving specific issues and problems.

Based on my experience as the CTP Ombudsman, I can help EAS tobacco clients navigate their way through a new Center with new procedures and in compliance with a new law. Specific tobacco topics I have been involved in include: substantial equivalence, deeming (e-cigarettes, cigars, hookah), retail inspections and compliance, menthol, export/import, harmful and potentially harmful constituents, labeling, registration, standards, modified risk, adverse events, graphic health warnings, flavor ban, and user fees.

EAS clients can also benefit from my CTP and CDRH experience handling more general issues that are of concern to all industries that are regulated by FDA, not just tobacco and device companies. These included: level playing field, transparency, regulatory compliance, status of premarket and other submissions, miscommunication or lack of communication, meeting requests, difficult or unresponsive FDA employees, and of course dispute resolution. I also attended meetings between companies and FDA to ensure that they were listened to in a forum that was conducive to effective and productive dialogue.

I am available to make presentations at conventions, conferences, workshops, and other industry sponsored meetings on my new role as an EAS Senior Consultant. This is part of my outreach efforts to inform trade and professional associations and their members about what I did as an FDA Ombudsman, how I did it, and how I might now be of assistance to EAS clients and potential clients.

Commenters Say Re-proposed FSMA Animal Food Rule Needs Further Revision

 

The December 15 comment deadline on FDA’s re-proposed rule on Preventive Controls for Animal Food has come and gone. Stakeholders generally welcomed the supplemental proposal as an improvement on the original proposed rule. But further significant changes are needed, according to recent comments submitted to FDA.

Valley Proteins Inc., of Winchester, VA, one of the nation’s largest independent renderers, says in a December 8 comment that the final animal food rule should not include a “blanket requirement” for product testing for rendered products used in food for animals. Product testing has “limited value in confirming that control measures are effective” because testing in and of itself does not protect against hazards occurring in foods, the company suggests. “Rather than focusing on a testing procedure, the focus should be on adherence to the processes and controls that provide the true protection, such as maintaining the appropriate cooking temperature, etc.,” it says.

Similarly, environmental monitoring is not appropriate for many parts of the rendering process, the company contends. The process takes raw materials such as inedible meat parts and used cooking grease and converts them into fats and proteins used as ingredients in animal feeds and in biofuels. “By its nature, rendering takes raw materials that are, in a sense, contaminated and converts them into clean, safe products for use in the food supply,” says Valley Proteins’ President, Gerald F. Smith Jr.

“The final rule should not mandate environmental monitoring for rendering but should allow for the facility to determine whether such monitoring is necessary or appropriate,” he says.

West Central Cooperative of Ralston, IA, a farmer-owned group connecting producers of agricultural products to a network of processors and end-users worldwide – one of the 20 largest grain companies in the U.S. – says in a December 11 comment that the proposed rule should be “revised significantly” to reflect the intent of FSMA and “provide sufficient flexibility to allow facilities to adopt animal feed and pet food safety practices that are practical and effective for their specific, individual operations.”

The proposed rule would for the first time require current Good Manufacturing Practices (cGMPs) for food for animals, along with hazard analysis and risk-based preventive controls. The re-proposed rule also includes a new definition for the phrase “significant hazard.”

“We generally support FDA’s new proposed term ‘significant hazard,’ because it would better define those hazards for which rigorous management control activities may be needed,” says West Central’s President and CEO-elect, Milan Kucerak. “However, we believe the proposed regulation should be further revised to provide firms with appropriate flexibility to manage feed risks in a manner commensurate with the hazard,” he says.

Any product testing or environmental monitoring requirements should only be applied to significant hazards, if any, present in the firm’s operation, Kucerak says. The significant hazard approach should also be applied in the context of hazards that may be intentionally introduced into products for economic gain, as well as for supplier program requirements that the firm relies on its supplier to control, he says.

In a December 9 comment, the Michigan Agri-Business Association says it is particularly concerned that FDA’s proposed cGMPs establish reasonable and practical requirements for animal feed and pet food, and not be based on requirements necessary for human food. Many of the proposed requirements “inappropriately focus on the hygienic design and construction of equipment and facilities, and would establish standards that are required for human food. We strongly believe that FDA must make significant revisions to the proposed cGMPs so that the final regulation does not add unnecessary requirements that would cause animal feed and pet food companies to expend millions of dollars towards attempting to comply with regulatory obligations that are not need to assure the safety of animal feed, says James E. Byrum, the association’s president.