Wednesday, April 13, 2016

>> Hurry, registration is limited!

Food Law Current Issues Seminar
Michigan State University        East Lansing, Michigan

July 12-14, 2016

The MSU Food Law Current Issues Seminar provides practical education on current food legal and regulatory issues. The seminar covers cutting edge issues in international, transnational, and national food law and policy including FDA and E.U. food ingredient and safety regulations, U.S. advertising and labelling law, and globalized supply chain liabilities and management strategies. Speakers from the legal, food industry, and academic professions will present practical food law information and case studies.

This seminar is for a global audience in food regulatory work, including industry regulatory affairs, quality assurance, government officials, the legal community, advertising and marketing professionals, academics, and policy makers.

The course is offered in a collegial, intimate learning environment. Time will be allowed for questions and answers as well as informal discussions over lunch and coffee. In addition to the educational sessions, social activities are planned on a voluntary basis.

The cost for the course is $1345 until May 15th; after May 15th registration will be $1545.

For more information, click here

The Faculty

P. Vincent Hegarty PhD, Founding Director/Professor Emeritus, MSU, Institute for Food Laws and Regulation

Elizabeth H. Dickinson, JD, Chief Counsel to the FDA [invited]

Leslie Bourquin, PhD, Professor of Food Science and Human Nutrition, Michigan State University

Stuart Pape, JD, Shareholder, Polsinelli

Charles Breen, Senior Consultant, EAS Consulting Group

Ken Odza, JD, Corporate Counsel, Food Safety, Kellogg Company

Robert Prevendar, MPH, Managing Director, Global Supply Chain Food Safety, NSF International

Daniel Dwyer, JD, Partner, Kleinfeld, Kaplan and Becker, LLP

Tim Slawinski, Emerging Issues Specialist, Michigan Department of Agriculture and Rural Development

Howard Sklamberg JD, Deputy Commissioner for Global Regulatory Operations and Policy, FDA [invited]

Francesco Planchenstainer, JD, PhD, Senior Regulatory & Food Law Specialist at Mead Johnson Nutrition

Robert Hollingworth, PhD, Emeritus Professor of Entomology, Michigan State University

Bill Marler, JD, Managing Partner, Marler Clark

Hannah Chanoine, JD, Counsel, O’Melveny & Myers; Lecturer-in-Law, Columbia University School of Law

Jennifer McEntire, PhD, VP, Science Operations, Grocery Manufacturers Association

John Spink, PhD, Assistant Professor and Director of the Food Fraud Initiative, Michigan State University

Shawn Stevens, JD, Food Industry Counsel LLC

Adam Ekonomon, JD, Director and Assistant General Counsel, Marketing and Regulatory, The J. M. Smucker Company

Mary Engle, JD, Associate Director for Advertising Practices at Federal Trade Commission

Kimberly Wingfeld, Director, Science Policy, Labeling and Standards, Grocery Manufacturers Association

Latasha Robinson, Branch Chief of Labeling and Dietary Supplement Compliance, FDA [invited]

Steve Steinborn, JD, Hogan Lovells, U.S., LLP

 Learn more about IFLR at: 

Tuesday, April 05, 2016

Ever heard of a letter of no objection?

By Michaela Oldfield / Global Food Law Fellow

Me neither, until I went to a lecture at the Food Science and Human Nutrition Department on the safety of recycled plastics in food contact materials. Anyone familiar with the ol’ BPA in canned foods issue should know that what is in the materials that food is packaged in is as important as what is actually in the food.

I’ll get to the letter of no objection, but first want to explain how food packaging material is generally regulated. Because recycled plastics are a deviation from the usual pre-market approval that most food packaging goes through.

Under the Food, Drug, and Cosmetic Act (FDCA), 21 USC 301 et seq., the FDA regulates materials in food packaging as food additives if they have the potential to become a component of or otherwise affect the characteristic of a food. 21 USC 321(s), 21 C.F.R. § 170.3(e)(1). Such product are known as Indirect Food Additives.

The FDCA treats food contact substances that are food additives as unsafe unless there is regulation prescribing the conditions when the additive may be safely used, 21 USC 348(a)(3)(A), or a company has submitted a notification to the FDA and the notification is effective, 21 USC 348(a)(3)(B).

The regulations allowing food contact substances are pretty straightforward. The FDA has promulgated a list of materials that can be indirect additives. 21 CFR parts 176-178. A material may also be exempt from regulation because it falls under a regulatory threshold. 21 CFR 170.39. There is a list of materials and their intended uses that have met this exemption.  

The notification process, on the other hand, is not so straightforward. A notification is submitted according to procedures laid out in 21 USC 348(h). A manufacturer may submit a notification to the FDA at least 120 days prior to introducing a food contact substance. (Note the “may”. This process is technically voluntary. However, if food contact material is an additive, and it is not generally recognized as safe, then the product will be deemed adulterated absent an FDA accepted notification. So the notification process becomes de facto mandatory for many new food packaging materials).  

The notification must provide the identity and intended use of the substance and the manufacturer or supplier’s determination that the substance is safe and doesn’t cause cancer, and the information that forms the basis for the safety determination. 21 USC 348(h)(1).

The notification becomes effective 120 days after submission to the FDA unless the agency makes a determination otherwise. 21 USC 348(h)(2). The agency may either object to the notification, 348(h)(2)(A), or require the manufacturer or supplier to submit a petition for regulation of the food contact substance 348(h)(3). This is the Food Contact Substance Notification program. The FDA maintains a list of additives that have been approved through this procedure.

To recap: a food contact substance is deemed unsafe unless it is allowed by regulation or there is a notification in effect. A company may submit the notification, and unless the FDA takes action, the notification becomes effective 120 days after submission to the FDA. If the FDA does not object, they will issue a letter notifying the submitter of the food contact substance and the date the notice became effective.

So here’s what that all has to do with a letter of no objection.

Like any other food contact substance, recycled plastics used in food packaging become food additives if they have the potential to become a component of the food or affect its structure. Thus, recycled plastics must meet all applicable regulations on indirect food additives.

On paper, this is easy peasy. Source plastics that were previously food contact substances, reprocess them into new packaging, and you’ve got a food contact substance that meets the applicable regulations.

The reality is recycling is a messy, funky process that involves a lot of products being mingled, mashed up, solvenized, blended and I don’t know what else. And this is done all over the world, subject to whatever regulatory authority operates in the country where the recycling occurs.

A supplier may promise that a recycled plastic meets the FDA standards, but food manufacturers sourcing post-consumer plastic for a product may want to be a little more confident that their packaging material will meet the FDA’s standards and consumers’ expectations.  Companies can use one of three approaches to do this.

    1. They can send the packaging to a lab to be tested for contaminants. The speaker noted he has found that by the time the results get back to a company the packaging has often already been put on food and sent out into the marketplace. When this happens, the food manufacturer often requests a credit from the plastic supplier for providing a plastic that did not meet the standards the supplier promised. Unless a consumer advocacy group or the FDA randomly tests the packaging material, it likely ends there.
    2. The company can integrate continuous material testing into the manufacturing process so that a company can know what is in their packaging materials before they even put food anywhere near it. This technology is not fully operational yet, but food manufacturers are investing in its development. Someday that packaging material might even have a QR code that can give consumers the exact data from the in-time monitoring about what materials are in their food’s package.
    3. The food manufacturer can source recycled plastic from a company that has obtained a  “letter of no objection” from the FDA verifying that the waste stream and recycling process should result in a plastic that meets FDA’s standards.  

Do any of these look problematic? The first one might be worrisome to consumers, but Dr. Vorst has found the third is actually far more problematic. Even though on paper it all looks good, there’s never any verification that a company is actually using the recycled materials they said they would or putting them through the process they claimed to have.

This kind of on-paper compliance and in-reality disconnect might sound familiar to anyone that has followed the drama of food safety certifications and the enactment of the Food Safety Modernization Act over the last 10 years.

So what’s going on, what is a letter of no objection and why does the FDA issue them?

Like food manufacturers, the FDA has concerns about the suitability of recycled plastic for food contact materials. “FDA considers each proposed use of recycled plastic on a case-by-case basis and issues informal advice as to whether the recycling process is expected to produce plastic suitable for food-contact applications.” The agency provides guidance on how to determine the suitability of recycled plastics and what information should be submitted to the agency to receive this informal advice.

So the letter is documentation that the FDA has reviewed the company’s proposed waste stream and recycling process, and according to their assessment the resultant plastic will meet the FDA’s standards for food contact materials.

Why provide guidance and letters of no objection, rather than require testing and approval? In short, the FDA doesn’t have authority to mandate that companies do pre-testing on their food contact materials. FDA’s authority is to require premarket approval of food contact substances, which applies to virgin materials. As long as a company is sourcing from an appropriate waste stream, the materials will have already received premarket approval.

The FDA can test recycled plastics after they’re on the market to ensure that the manufacturer used an appropriate waste stream. But the FDA has limited resources at best to engage in this kind of oversight and enforcement. Providing guidance and informal advice was the next best thing the FDA could do to try to regulate recycled plastics in food packaging materials.

As it stands, it falls to companies to figure out which plastics meet the FDA’s standards and which don’t. If they ignore the issue, a random consumer advocacy organization doing testing could expose them - and their entire product industry, such as bottled water - to scrutiny and bad PR.

With advances in technology and faster lab diagnostics, companies will be able to bypass this system and rapidly test raw materials as they come in to evaluate whether they’re usable. By the same token, it will become easier for consumer groups and the FDA to do the same with finished products, putting more pressure on companies to avoid unscrupulous suppliers.  

So now that I’ve added to the litany of issues spurring consumer fears about plastic, I’ll add one last gem. While food packaging materials are at least loosely regulated, the solvents and binders in paper products are largely unregulated. Unless a company uses stringent material sourcing, the problems from general paper production can seep into food packaging materials.

The speaker had an example of the paper wrapping on chocolate creating an off flavor that was bad enough to prompt a consumer complaint and spur the company to investigate!  Lesson: I should stop microwaving my popcorn in a brown paper lunch bag, even though it is easier than stove top and cheaper than store-bought microwaved popcorn.

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