Editor’s note: The following article is based on “Making a Claim: Formulation Amid Regulation,” presented by Mark S. Hostetler, attorney, Husch Blackwell Sanders LLP, on September 22, 2008, at Prepared Foods’ New Products Conference, Scottsdale, Ariz.

Dietary and food safety concerns dominated much of the legislative and regulatory activity in this past year and represent categories in which we can anticipate much regulatory and legislative activity in the year ahead. Here is a look at some specific areas

Food Safety
Among the bills introduced in the Congress were the Food Safety Authority Modernization Act; the Food Import Safety Act of 2007; the Food and Drug Administration Globalization Act of 2008; the Food Tracking Improvement Act; Improving Foodborne Illness Surveillance and Response Act; the Ending Agricultural Threats: Safeguarding America’s Food for Everyone Act (or the EAT SAFE Act); and the Safe Food Enforcement, Assessment, Standards and Targeting Act (or the Safe FEAST Act).

Some form of increased agency or third-party participation in the import process through “certification” is a recurring theme. Foreign facility certification would require that a country demonstrate that it maintains safety standards at least as protective as those in force in the U.S. and that the exporting country has a program to monitor and enforce the food safety standards. Proposals include authority to prohibit the importation of food generally or a specific food, if a pattern of violations is detected and the prohibition is appropriate to protect the public health. A similar bill would permit an embargo, if the food has been associated with an outbreak of disease, presents a reasonable probability of significant adverse health consequences and is likely to recur unless stopped.

Representative John Dingell, of Michigan, raised many of these concerns as a Discussion Draft. The proposed bill included a broad provision for the use of third-party certification. Under the Dingell proposal, FDA would accredit foreign governments, state or local food experts and private parties to perform inspections. Food companies would “voluntarily” seek certification from one of the certifiers. Non-certified companies would receive inspection by FDA twice as often and could not participate in an expedited import entry process. FDA would be required to inspect accredited food facilities at least once every four years.

On July 10, the FDA published its draft guidance on “Voluntary Third Party Certification Programs for Foods and Feeds” (FDA2008-D-0381). The Guidance is offered for discussion only and represents FDA’s current thinking. However, any prudent producer or exporter/importer should review the Guidance and be mindful of the implications of the Guidance, if it is finalized in any form.

Important definitions within the Guidance include:

* Certification body: “a third party organization…that is independent…and free of conflict of interest.”
* Certification: “the establishment conforms to specified criteria, no Warning Letters/Official Action(s) Indicated, or legal actions pending and a review of records.”
* Certification program: the right to inspect, a defined scope, depth and nature to vary by product; a review of records related to “safety and security” and collection of samples. The certifiers (should) have the charge to recommend or approve corrective action plans, and “they should also have authority to provide information to FDA, including inspection and corrective action reports and records.” Certifiers (should) “promptly notify FDA,” when “...there is a reasonable probability that U.S. consumers may consume or be exposed to a food that could cause serious adverse health consequences…”

The Guidance suggests that third-party certification may become an important part of the FDA food safety program, with additional incentives to companies who participate. Prudent companies will monitor the situation and be prepared to comment or react accordingly.

Much of this activity is centered around the work of the Interagency Working Group on Import Safety, its Action Plan for Import Safety and its recent Action Plan Update and implementation of a Food Protection Plan. The key elements of the overall Food Protection Plan are prevention, intervention and response. Implementing elements include risk-based approach, outreach, and “track and trace.”

The recently introduced Food Tracking Improvement Act includes significant new requirements for the tracking of food--mandating within three years a system to track food throughout the entire system with a code or marking that would enable FDA to identify the history, use and location of the food at all times. Such a system would require additional recordkeeping requirements at every level of the production and distribution cycle. A companion bill was co-sponsored by then-senator Barack Obama, so this form of legislative direction may have an even higher profile in the year ahead.

The Meaning of “Natural”
Another issue for 2009 and beyond is going to be how to use the word “natural” on the labels and in advertising of food products. The USDA is currently entertaining a discussion of the meaning of “natural” and “naturally raised,” with regard to meat protein products. Historically, FDA has defined “natural” as the absence of “artificial” ingredients. USDA has defined “natural” as the absence of “artificial” ingredients and “minimal processing.” In a recent exchange of correspondence between the FDA and the Corn Refiners Association, with regard to high-fructose corn sweetener, FDA stated that “artificial” means an ingredient “...that would not normally be expected to be in the food.”

At this point, regulators seem to take little interest in the meaning of natural unless asked, and the Center for Science in the Public Interest (CSPI) and competitors are the only ones interested. This is manifested only by applying an “appropriateness” for the food, rather than a scientific standard.

The National Advertising Division (NAD), a voluntary ad industry self-regulatory group, says that, “a minute (i.e., 1%) part of the overall” product may preclude an advertiser from sending the message that the finished product is natural and constitutes deception, because of consumers’ “significant interest” in the naturalness of product ingredients.

Allergens, Antioxidant Guidance and Sodium Issues
FDA is seeking input on approaches to deal with the risk of residual and cross-contamination and the effect of warnings currently in place. There is a concern that the standards used across the industry to assess the risk of cross-contamination are not uniform and, as a result, not fully informative to sensitive individuals. The FDA held hearings in September to gather information on the use and utility of advisory labeling on food products which “may contain” allergens. Under the law, when one of the eight major allergens is present in a food product, it must be labeled. The law is not clear on the use of “advisory” labeling, i.e., “This food product was produced in a food facility which also produces tree nut products.” Questions the FDA considered include: “Under what circumstances should advisory labeling be used?” “What type of advisory labeling is most effective in communicating to consumers?” and “How should advisory statements be worded to convey the most effective information to consumers?” The public is still awaiting FDA definitions or clarifications with regard to certain gluten labeling.

The FDA issued a Guidance for Industry in the form of Questions and Answers addressing the meaning of “high-potency,” “antioxidant” and “sugar-free.” Antioxidant claims are nutrient content claims that may be used only with nutrients that have a Recommended Daily Intake (RDI) and antioxidant activity. The Guidance is titled, “A Small Entity Compliance Guide,” and is understandable and available at the Center's website, www.cfsan.fda.gov.

The CSPI’s Sodium Citizen’s Petition is still pending at FDA. The Petition asks FDA to revoke the Generally Recognized as Safe or GRAS status of salt; to limit the amount of salt in processed foods; and to develop and require a salt/sodium health message on food labels. CSPI seeks a reduction in the Daily Value (DV) of sodium, from the current levels to 1,500mg. FDA has noted, in partial response, that because it has a Notice pending to examine and readjust as necessary any current DVs (see below), that portion of the Petition will not be considered, except as a part of the larger undertaking. FDA’s Notice also raised for public comment the issue of whether or not reducing the sodium content of a processed food is feasible.

Nutrient Labeling and Marketing to Children
In late 2007, FDA published an Advance Notice of Proposed Rulemaking looking for comment on what new, if any, Reference Values should be used to calculate the percent DV in the Nutrition Facts and Supplement Facts panel. That proposal is still under consideration.

* Calories. Should 2,000 calories be kept as the reference energy intake? What changes can be made to enhance consumer understanding of a food’s caloric value or contribution to a diet? Do consumers understand “calories from fat,” and should it continue to be a part of the label? Should the DV for saturated fat be changed? Where should the Daily Reference Value (DRV) for trans fat be established? Should monounsaturated and polyunsaturated fat labeling be voluntary or mandatory?
* Cholesterol. Is a DRV of 300mg/day appropriate?
* Carbohydrates. Is the current method of calculating carbohydrates correct? Should dietary fiber be a part of the carbohydrate calculation?
* Dietary fiber. How should dietary fiber be defined?

In the area of marketing food to children and adolescents, if a company markets to or targets a food to children, it will want to review the Federal Trade Commission’s report on “Marketing Food to Children and Adolescents--A Review of Industry Expenditures, Activities and Self-regulation--A Report to Congress.” The Report summarizes information compiled from some 44 companies who market to children. The information and conclusions of the Report may someday show up as the research basis for new and innovative restrictions designed to regulate food products and the promotion thereof to children.

Country of Origin Labeling and Imports
On September 30, 2008, legislation became effective requiring country of origin labeling (COOL) on meat protein products, fruits, vegetables and some nut products. The legislation and implementing regulations remain unclear in application to “commingled covered commodity” or “processed” foods. The operative concept remains “substantial transformation.” Food products that are “substantially transformed” in the U.S. need not bear COOL; not processed or non-transformed food products require COOL. Questions of application will arise when, for example, a single vegetable food product requires COOL, but a multi-vegetable food product does not, because it is “processed” or “substantially transformed.” Protein animals raised outside of the U.S., but slaughtered in the U.S., may be able to bear the label of both countries.

In the area of imports, FDA has issued a proposal to require the food refused entry into the U.S. be clearly marked with a label stating, “United States: Refused Entry.” The idea is to halt or prevent the practice of “port shopping,” where product refused at one point of entry is delivered for import at another port. The public has until December 2, 2008 to comment on the proposal.

Author’s Comment
Concerns about the U.S. economy will likely weigh heavily on Congressional activity in 2009. To the extent that economic legislation will command much of the Congress’s time and energy, questions of import and domestic food safety, while still very topical, will be pushed to the back burner. Also, when taxpayer dollars must go to bail out financial institutions, fewer dollars will be available to fund any new FDA/USDA and Customs department initiatives. There will not be room in agency budgets to increase staff in order to accept any new oversight obligations. Nevertheless, any “food crisis” will result in the immediate call for new food safety legislation, increased inspection and enforcement measures. Additionally:

* Food safety will continue to be a priority in the new Congress (January 2009). Much of the legislation proposed in the last Congress intended to legislate “food safety” will be reintroduced. Many senators and representatives view “food safety” as a constituent hot-button.

* In the Executive Offices, the Interagency Working Group will continue its work promoting a Food Protection Plan.
* At FDA, new concerns in China surrounding melamine in the milk supply, while not directly involving the U.S. consumer, will nevertheless be cited in a call for more strict supervision of imported foods.
* Any new domestic Salmonella, E. coli or Listeria outbreaks will surely be cited as evidence that current food safeguards or tracking systems are inadequate.
* Because dollars to fund increased surveillance by FDA and USDA will be limited, much of the call for increased inspection will look to third-party and government “certifiers”--all in an effort to reduce the financial commitment of federal agencies.
* There will be an increased legislative and regulatory emphasis on “tracking and tracing” the movement of food products for recall and surveillance purposes.
* FDA will continue to devote time to reviewing and approving new health claims, but, due to the expense in time and dollars for the review process, fewer and fewer proposals will make it through the system in the year ahead.
* The food industry should look for specific new proposals on the labeling of gluten and advisory warnings on food allergens.