Food Laws and Regulations Division

Newsletter - Vol. 8, No. 2 - Winter 1998

Table of Contents 

Message from the Chair --Jim Heimbach

"This is an exciting time to be involved with food law and regulation, because this area is in a ferment such as I have never previously seen." --Jim Heimbach

Pathogen control is driving new regulatory approaches in the area of pathogen control (such as mandatory HACCP and fast-track approval of irradiation), pesticide residues new cancer guidelines the new requirements regarding estimation of aggregate exposure, assessing endocrine disruption, developmental toxicity in the Food Quality Protection Act and evaluation of new food additives (such as FDA's streamlined petition reviewed by Special Project Teams and its proposed conversion of the GRAS petition process into a notification system). (addressed by the from EPA), and "Functional foods" are finally coming into their own as the major multinational food companies begin serious entry into this market, resulting in challenging issues regarding safety and efficacy and the regulatory positioning of products as drugs, supplements, foods for special dietary use, medical foods, functional foods, and just- plain foods. But nowhere are things happening faster than in the international arena. It is difficult to discern what is due growth in world trade to the specifically GATT and establishment of the World Trade Organization, but Codex Alimentarius and other international fore have moved from being backwaters into major concerns of both international and domestic food companies and suppliers. to the explosive and what is due the One exciting result of this internationalization of the food industry is that, for the first time, the IFT annual meeting in Atlanta is being held jointly with the Canadian Institute of Food Science and Technology (CIFST) and the Mexican food science organization ATAM. FLRD, of course, is part of the drive to internationalism, as is clear from the excellent symposia arranged by our Chair-Elect, Barbara Rasco, and described elsewhere in this newsletter. The Executive Committee teleconference on December 11, reviewed the budget and learned that we are doing well, and Ted Labuza. past chair and head of the Nominating Committee, presented a slate of proposed candidates for leadership positions within the division. Please vote with the enclosed ballot. We We also discussed plans for a strategic planning meeting to define the mission of the division and to lay out a strategy to carry us into the new millenium. (Ouch! That's a cliche, but it's still appropriate.) We need to assure that the division is serving the needs of its members and--on a larger scale--of all the members of IFT. This planning meeting was approved and budgeted for at the Executive Committee meeting in Orlando last June, and will be held this spring in late March or April. We will plan to hold it at an airline hub city such as Chicago or St. Louis. If you are interested in being a part of this key meeting and are ready to give a day to support the Food Laws and Regulations Division, please e-mail me at jheimbach@environcorp.com. We will have a division luncheon either Monday or Tuesday in Atlanta at our annual meeting with a featured speaker and a chance to interact with your fellow division members Plan to attend. I'll see you there!

Washington, D.C. The Foundation on Economic Trends' Pure Food Campaign has announced the launch of a new nationwide SOS (Save Organic Standards) campaign with picket lines and press conferences scheduled for Los Angeles, Minneapolis and Burlington, Vermont. The SOS campaign comes in response to the controversial U.S. Department of Agriculture's proposed federal regulations on "national organic food standards" which were published in the Federal Register on December 16. The USDA regulations are designed to replace the pre-existing rules and labeling practices on organic foods currently upheld by 40 independent and state-sanctioned organic certification boards.

Over the objections of the majority of the advisory National Organics Standards Board, natural food retailers, processors, and organic farmers, the USDA has refused to prohibit the use of genetic engineering, intensive animal confinement, food irradiation. toxic sludge, or animal cannibalism under the new federal organic labeling regulations.

In response to the USDA proposed laws, the Foundation on Economic Trends has begun to launch a nationwide campaign called "SOS" or Save Organic Standards. The SOS campaign will include natural food consumers, hundreds of natural food stores and consumer coops, organic farmers, chefs, public interest organizations and natural food processors, wholesalers and manufacturers.

"Genetic engineering, factory fanning, toxic sludge, food irradiation, feeding rendered protein to animals--these are the agricultural practices that are causing consumers to switch to organic foods in the first place. We will organize a mass movement of consumers, retailers, and farmers to save organic standards," stated Jeremy Rifkin, president of the Foundation on Economic Trends.

"Once again the USDA is acting as the handmaiden for agribusiness@ said Ronnie Cummins, director of the FET's Pure Food Campaign. "These standards have been watered down so that agribusiness factory farms and chemical and genetic engineering companies can take over a $4 billion dollar industry which has so painstakingly been built up by natural foods consumers, farmers, and retailers over the past three decades," Cummins concluded.

Contributed by Jack Cooper-Food Industry Environmental Network Network (FIEN) E-Mail: JLC@fien.com

An Insight into Patentability --David D'Zorilla

In order for an inventor to be granted a patent on his or her invention, the invention must be both novel and nonobvious over the prior art. Novelty is a relatively easy concept in comprehend--in order to be eligible for a patent, an invention cannot have been previously made or disclosed in a single embodiment or in a single prior art reference. It is therefore possible for a food industry professional, before seeking the advise of experienced patent counsel, to initially make a determination whether a proposed product for formulation would or would not be novel, However, even though an invention may be novel, it may still not be eligible for patent protection.

In addition to novelty, an invention must be nonobvious over the prior art and the concept and determination of nonobviousness is more complex than novelty. Even though an invention may be novel since it is not disclosed in a single prior are reference, modifications to that reference may be considered obvious to a person of ordinary skill in the art thereby precluding patent protection for such modifications. While this determination may be somewhat more involved than novelty, a recent case from the U.S. Court of Appeals for the Federal Circuit illustrates in a relatively straightforward manner the determination of nonobviousness (Richardson-Vicks Inc. v. The Upjohn Company, 44 USPQ2d 1181 (CAFC 1997)). In this case, the plaintiff was the owner of a patent addressed to an over-the-counter medicine that combined in a single unit dosage two well-known ingredients--the analgesic Ibuprofen and the decongestant pseudoephedrine. The most relevant prior art included two cough and cold formulations. The first was combination of acetaminophen and pseudoephedrine sold as a single unit dosage under the brand name Co-Tylenol7. Pseudoephedrine had also previously been combined with aspirin in a unit dosage for treating cough and cold symptoms. Consequently the combination of an analgesic (aspirin or acetaminophen) and a decongestant (pseudoephedrine) was known to be particularly effective for treating since headaches, Doctors have been taught in medical school to treat sinus headaches by prescribing both analgesics and decongestants together. In fact, there was evidence Ibuprofen in combination with pseudoephedrine, albeit not in a single unit dosage.

The difference between the other single unit dosage cough and cold product such as Co-Tylenol® and the claimed invention was that the former used a different analgesic (i.e. acetaminophen). The difference between the prescribed combinations and the claimed invention was that the former used a different analgesic (i.e. acetaminophen) . The difference between the doctor prescribed combination and the claimed invention was that the doctor=s prescriptions assumed that analgesic Ibuprofen and the decongestant pseudoephedrine would be in physically separate tablets.

The court held in this case that the single dosage of Ibuprofen and pseudoephedrine would have been obvious to one of ordinary art at the time the invention was made. The court pointed out that the prior art taught that the combination of an analgesic (aspirin or acetaminophen) and a decongestant (pseudoephedrine) in single unit dosage was known to be particularly effective for treating sinus headaches. Ibuprofen was a known analgesic that was interchangeable with either aspirin or acetaminophen. Moreover, Ibuprofen had previously prescribed albeit not in a single unit dosages, in combination with pseudoephedrine by doctors. Therefore, the court stated that the only difference between the previously prescribed combination was not contained in a single tablet. However, such a combination is clearly suggested by the prior art including Co- ylenol®, which combined an analgesic with pseudoephedrine in a single tablet. This article is not meant to serve as legal advice, which can only be given a thorough review of the facts in a particular case. Any questions or comments: regarding the above should be directed to David D'Zurilla at (202) 337-8073, or E-mail : lam@access.digex.net.

Dietary Supplement Update --Jim Vetter

In accordance with the Dietary Supplement Health and Education Act of 1994, FDA published on September 23, 1997 Final Rules for implementing some of the major provisions of the Act.

The first (pages 49825-49858 of September 23^rd Federal Register) requirement for the identification of dietary supplements and for their nutrition and ingredient labeling. FDA is requiring that the phrase "dietary supplement" be included in the name of a product marketed under dietary supplement regulations; terms such as "food supplement" and "energy bars" are not appropriate. "Supplement Facts" will be used for dietary supplements in the same way that "Nutrition Facts" is used for conventional foods. The Supplement Fact panel must contain declarations for the 14 nutrients that are added. The quantitative amount of dietary ingredients for which no RDI or DRV has been established must be listed in the Supplement Facts panel along with an asterisk referring to the statement "Daily Value Not Established". Effective date of December 31, 1996 was established by DSHEA, but FDA is announcing that it will use its "enforcement discretion" (no action for noncompliance) until March 23, 1999.

The second Final Rule (pages 49859-49868 of the September 23^rd Federal Register) clarifies that dietary supplement with no reference that associates it to a conventional food on the label or in labeling. This Final Rule also clarifies that nutrient claims for conventional foods also apply to dietary supplements.

The third Final Rule (page 49868-4988 1 of the September 23^rd Federal Register) defines a high potency@ and "antioxidant" as nutrient content claims for both dietary supplements and conventional foods. "high potency" is defined as 100% of the DRV or RDI in the reference amount of the food or supplement and may be used for vitamins and minerals, but not protein and fiber. Conventional foods may be fortified to achieve the 100% level. "Antioxidant" is defined to include vitamin C, vitamin E, and beta-carotene. If one or two of the nutrients are not present, the nutrient(s) present must be specified. In other words, if the statement "good source of antioxidants" is used on the label or in labeling, the reference amount of the food must contain 10-19% of the DV of vitamin C, vitamin E and beta-carotene. The claim must comply with all other nutrient content rules.

Editor's Corner...

Dear Editors: Thank you for sending me the fall newsletter that included the article on Paul Khan. I am the only close family left and the remembrance of Paul was special. Paul was special, indeed, and can not be replaced in my life nor in the work he did. 1 am proud to know that so many people thought highly of him. Grace Khan (Wife)

Correction: The Fall newsletter had misspelled Paul Khan's last name. Please forgive the editors for this typo...

Newsletter Deadline May 15, 1998 Please submit articles or information for the next newsletter by May 15, 1997 Send information to the Editors at the address below. Please send comments, suggestions, concerns and corrections to us, we want to hear from you.

Symposia For June 1998 Annual Meeting

Co-Chairs: Gary Henderson-Kraft and Steve Ziller-GMA
Sponsors: FLR Division
Monday AM, June 22

This symposium will review and contrast the regulatory approaches being used in various countries or regions of the world with respect to foods and ingredients produced through the use of biotechnology. Speakers from North America, Europe and the Far East will discuss issues related to labeling, food safety, and environmental release of genetically modified organisms (GMO). Perspectives from government, industry and consumer groups will provide IFT members with an excellent assessment of where the regulations of biotechnology is today, where it is going in the future, and what the challenges are for harmonization. Many agricultural crops modified through biotechnology are now being introduced into international commerce. The foods and ingredients from these crops are widely used in many processed food products. The trend as seen by regulatory activity in various countries is that the number of biotechnology crops will continue to increase. In the midst of this, the framework of some countries to regulate the products of biotechnology is only now starting to develop. This has led to uncertainty about the regulatory requirements and has added to concerns expressed by consumers about this technology.

Four symposia have been approved by the Annual Planning Committee. For further information contact Barbara Rasco, University of Washington-lnst. Food Science & Tech. Seattle, WA 98195 Phone: (206) 685-1203 FAX: (206) 543-1417 E-mail brasco@fish.washington.edu

Student Representative Report --Justin Shimek, Student Representative

As this year's student representative to the Food Laws and Regulations Division Executive Committee I intend to enhance the student involvement and identify means to increase the FLR Division student members base. According to the FLR Division 1997 figures, 5-6% of the members in FLR Division are students. I believe that students join divisions for many of the same reasons as their profession counterparts to  keep current in the area (newsletters, listserv and meeting symposia) and as a chance to interact and network with individuals that have parallel interests. An added dimension to student membership is that it also tends to be exploratory in nature. Students are evaluating their evolving career path. While legal and regulatory issues cut through almost every function of the food industry I do not believe that students abundantly know that fact: curricula are often focused on the scientific and technical topics.

To foster more student involvement in the FLR Division and interaction with professionals actively working with legal and regulatory issues 1 would like to propose an activity pioneered by students in the Food Engineering Division students and professionals meetings informally during the annual meeting. Basically, interested professional and students are paired and meet sometime over the meeting. This format allows individuals to fit a brief conversation into what is usually already a hectic meeting schedule. While the annual meetings is still a long way off I introduce the idea here and will mention it again in the spring newsletter.

One of the major student events at the annual meeting is the Student College Bowl. To ensure the representative of food law and regulations issues in the question bank each division is asked to submit questions (and answers). Guidelines for question format:

1. Answers consist of one or two words
2. No true or false
3. Multiple choice questions must have 4 choices

Please send your college bowl questions and/or your willingness to participate in the student/ profession connection at the annual meeting to me at jwshimek@ucdavis.edu or to:

Justin Shimek
Dept, of Food Science and Technology
University of California-Davis
One Shields Avenue
Davis, CA 95616-8598
Phone: 916-758-8140
Fax: 530-752-4759
E-Mail: jwshimek @ ucdavis.edu

Calendar of Events

Treasurer's Report --Karen Carson, Treasurer

We have not received a final report on the Division's balance at the end of the last fiscal year (August 31, 1997), so we are still working from an estimated end of year balance of $25,000.00. This does not include income from courses sponsored by the Division with IFT during last year. With those caveats- September-October dues received were $3,503.50 (budgeted -$8,000) and expenses to dale are $1,219.89. All expenses are associated with putting out the newsletter. $4,900.00 was budgeted for this purpose. This leaves the Division with an estimated balance of $27,263.61 (not including income from courses presented during the last fiscal year). I have communicated with the Chicago office about the fact that we have had this information by this time of the year. Hopefully, we will have it in time for the next Treasurer's report.

Division Sponsored Short Courses

The Division has been sponsoring two highly successful IFT Continuing Education short courses dealing with Food Labeling and Food Laws and Regulations. These courses are being scheduled for 1998 as follows: Food Labeling: February 16 and 17 in Orlando and early September in Southern New Jersey (date and location to be determined) Food Laws and Regulations: April 1 and 2 in Chicago and August 3 and 4 in Washington DC It has been necessary to limit enrollment and waiting lists have developed for most offerings of these popular short courses-early registration is highly recommended by calling IFT (312) 782-8424 for Food Laws and Regulations and AIB (800) 242- 2534 for Food Labeling.

Announcing Another IFT Videoconference!!!!

The second in a series of informative and timely videoconferences for IFT sections, universities and other interested groups

Title: EU Regulations: U.S. vs European Perspectives

Date: April 21, 1998

Time: 8:00-9:00 pm Eastern time

Starring:    Mary Wagner, IFT President
                  Peter B. Hutt, Covington and Burling
                  Richard F. Kingham, Partner, Covington and Burling

For further details... www.ift.org/video

Contact Paul Grassman at pdgrassman@ift.org or Call 312-782-8424

AFDO Position on National Uniformity For Foods, Drugs and Cosmetics

The Association of Food and Drug Officials (AFDO) has supported national uniformity in the regulation of foods. drugs. cosmetics, and consumer products throughout its 101 year history. No single organization has promoted the principles of uniformity more than AFDO through debate, negotiation and consensus building using federal, state, and industry perspectives. As a result, AFDO has forged partnerships and alliances to develop model codes, official guidelines, and training programs. These partnerships have received national recognition within the President's recently announced Food Safety Initiative which addresses current and future strategies for improved food safety. As strongly as AFDO supports national uniformity, AFDO opposes subordinating the states' fundamental obligation to act to protect public health in the absence of clear national standards or when there are regional public health concerns not adequately covered by national standards.

Many current and pending laws as well as states' requirements in the area of food, drugs and cosmetics are developed through joint efforts of multi-state cooperative associations, the federal agencies, academia, other conferences, and industry. Historically, laws developed by states in the absence of federal requirements have served as pilots and as a basis for improved federal requirements. In general, once federal laws are enacted, state laws are changed or rescinded to ensure uniformity.

It is of great concern that Congress is now pursuing broad preemption of individual state authority to regulate the manufacture, labeling and display of food, drugs, and cosmetics as a perceived burden created when different states have different laws. States must have the ability to act quickly to enact laws that address local and statewide public health concerns that cannot be anticipated or are not adequately address nationally. Where there is limited preemption, provisions must be available for the state to have a different law when justified by local or regional need for consumer protection. The exemption provisions provided under the Nutrition Labeling and Education Act are not acceptable as they do not provide a reasonable mechanism for exemption. Any exemption provision must include reasonable time certain for a definitive decision from the federal agency, and it must not include areas where final federal rules have not been implemented and state laws, therefore, are not specifically preempted.

The pursuit of board preemption is at odds with current Administration policies. The President's Food Safety Initiative recognizes states as the prime laboratories for "government reinvention" and recognizes federal-state cooperation, as opposed to federal exclusivity, as a major goal in achieving safer foods. Food safety is an area of joint government and industry responsibility where public health risks cannot always be anticipated and where the federal government cannot be omnipresent. Declining federal resources will continue to shift the burden of public safety to the states and makes it even less likely that citizens can rely on timely, responsive federal action. Therefore, the states must have the flexibility to address emerging issues.

Any federal requirement that interferes with the states' abilities to establish laws for foods, drugs, or cosmetics, when there is not specific existing federal law obstructs states' obligations and responsibilities to protect it's citizenry. National uniformity has been and continues to be a goal of AFDO, but not at the expense of consumer protection.

The Search for Uniformity --Betsy Woodward

(Excerpt from AFDO Newsletter)

One of the challenging issues with which we dealt this year was the issue of National Uniformity. Last year, the House proposed H.R.3200 which embodied sweeping preemption of state and local laws and regulations. At the time this legislation came to our attention, it had already been submitted to sub-committee and hearings had been held. A companion Senate Bill S.1477 did not have the same preemptive language. Neither bill passed.

Historically. the Food, Drug and Cosmetic Act has not had the type of federal preemption as found in the Wholesome Meat and Poultry Acts. The Nutrition Labeling and Education Act (NLEA) was the first federal legislation to provide limited preemptive provisions to the FDCA in label information requirements. The language of NLEA, sections A(b)(2-5), "any requirement for the labeling of a food of the type required by"...", has been interpreted by the FDA as providing preemption of the field. That is, if there is a requirement, it is preemptive; and, in the absence of a requirement, the federal government occupies the voids. Hence a state cannot have a requirement in the field, even in the absence of a federal requirement. Previous to NLEA all application of federal preemption in the FDCA relied on the provisions of Constitutionality, in that a state of local requirement could not impede interstate commerce or cause a product to be out of compliance with a federal requirement.

AFDO has always supported uniformity of food, drug and consumer product safety requirements and enforcement. As a matter of fact, uniformity is the reason for AFDO, as AFDO had its roots in 1896 in encouraging uniformity in foods and drugs before there was a federal food law. So wherein is the problem? The issue is not just uniformity, but rather the mechanisms to achieve uniformity and their impact on consumer protection and state and local programs. Local and state governments are closest to the citizenry and consumers turn first to their closest responsible government for protection and support. Certainly states have a fundamental responsibility for protecting their consumers and need to continue to be able to do that. Also of concern is the premise that state legislatures generally only fund programs in which there is a state component or interest. Running a federal program with state funds is not in their best interest either. Rooted in this debate is the fact that few, in either state or federal government, truly under-stand how foods, in particular, are regulated or what the roles, responsibilities and interactions are at the federal and at state/local level. Lacking this basic information and understanding denies Congress and State Legislatures the information needed to make good decisions for effective food safety regulation in this country.

Certainly AFDO supports uniformity. The issue is: Is there enough non-uniformity to necessitate the onerous use of the federal big stick, preemption? Most think not. Industry thinks it is necessary due to the burdensome costs of non-uniformity. Certainly the proposed language for Congress still uses the exact terminology of the above referenced NLEA provisions: "any requirement for a food of the type required by..." and then lists the provisions of the FDCA to be preempted. States have to live with the FDA interpretation of these terms. Some in the industry group indicate that it is not their intention to preempt voids, only those areas where there are federal standards and requirements in place. Peter Barton Hutt came to Minneapolis to delineate this position at the June meeting.

Preemption presents problems to state and local programs who frequently are incubators for new regulations, often as joint ventures with industry. It also presents problems for emerging issues and could require the resource poor federal agency to speak to every emerging issue whether local or national in scope, before a state or local program could act. Clearly, state and local programs need flexibility to address known and emerging or unknown issues in food and drug safety. The State of Washington points out that they required cooking hamburger to 155 degrees long before the federal agency did. There are many other examples where states have assumed a leadership role resulting in new, improved federal requirements. To deny this activity is to step backward in public health policy. Language has been proposed to avoid this interpretation. However, the proposed language remains the same as that in the NLEA, and it is not evident that this proposed language would protect the states needed flexibility to protect its consumers from unsafe foods and drugs and avoid the negative impacts of federally mandated uniformity. Laws tend to be interpreted narrowly when passed and broadly when enforced.

Associate members worked carefully with members of the AFDO Executive Committee to address this and other AFDO concerns. However, AFDO could not find agreement among the lawyers it consulted that this goal was actually achieved based on the proposed language. AFDO developed a Position Paper which reflects AFDO's position on the food issues. The AFDO Position Paper and GMA's response are printed in their entirety for your review. Certainly this author is no lawyer, and the perspective is that not that of state and local food program administrators. However, there still appears to be a gap between us, since AFDO feels that there is not that much non-uniformity with respect to the food and drug laws among the state programs, except in environmental areas not covered by the FDC Act. The notable exceptions under FDCA are Proposition 65 in California and state laws dealing with rBST and irradiation labeling.

Surely in this time of diminishing resources and needed federal/state cooperation, federally mandated preemption sticks in throats of us all. Especially is this true in light of the needed cooperation to accomplish the food safety improvements outlined in the President's Food Safety Initiative. There has to be a better way to work together. A beginning example certainly could be the NFPA Refrigerated Foods Labeling Guide and the workshops held at the AFDO meeting. There is more to be gained in cooperative effort than in statutorily mandated cooperation--true cooperative effort has always been and continues to be AFDO's motto: Uniformity Through Cooperation and Communication.

AFDO appreciates the open dialogue that it has enjoyed with the industry on this issue and hopes that we can continue to pursue a mutually acceptable solution. Certainly I enjoyed working with Claire Regan of GMA and Peter Barton Hutt and appreciate their willingness to hear our concerns. Peter made an unbelievable effort on short notice to attend the meeting in Minneapolis to present his thoughts and listen to ours. We, as responsible regulators, need to listen to industry's concerns, particularly when our actions might cause unreasonable burdens. Similarly, industry must understand that state and local governments must be able to respond to consumer concerns impacting their health and wellbeing. Clearly we can resolve these issues with time and effort.

Highlights of Executive Committee Conference Call --Dec. 11, 1998

Conference call conducted by Jim Heimbach-Chair, Committee Members Present: Jack Cooper, Jim Heimbach, Gary Henderson, Ted Labuza, Barbara Rasco, Mary Schmidl, Justin Shimek, Pamela Pierson- Staff

Submitted by: Barbara Rasco.

This page is maintained by the Food Law and Regulations Division of the Institute of Food Technologists. To submit materials for posting on the Division's home page or to make other comments, contact David Haytowitz

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Last modified: March 01, 1998