Prepared Foods Exclusive: Regulatory Environment in 2010
With so many issues before congress and the executive branch, the 2010 crystal ball looks a little foggy. While matters such as war, health care, and the economy will occupy much attention, certain non-final matters begun in 2009 will carry over. In addition, there are matters with compliance dates in 2009 but for which companies should check for full compliance heading into 2010, and there is always the risk that the next crisis or attention-grabbing headline will usher in a legislative or regualtory mandate.
Food companies should have in place procedures to implement the requirements of the Reportable Food Registry. "Responsible parties," including those facilities registered with FDA, are engaged in the manufacture, processing, and holding of food for consumption in the United States. When a responsible party becomes aware of a reportable incident (generally equivalent to the criteria of a Class 1 recall), it must use the "electronic portal" to alert FDA within twenty-four (24) hours of becoming aware that the food constituted a reportable incident.
FDA has established a new post-inspection response opportunity for companies. Firms who have received a Form 483 - Inspectional Observations now have a fifteen (15) day window within which to address the "significant objectionable conditions" noted and to respond to FDA. An inspected firm's response within 15 days will be included as part of FDA's review to determine the "apparent adequacy" of any corrections noted and whether or not a warning letter is warranted to achieve and implement compliance. Responses received outside of the 15 days, and any corrective actions noted therein, will not be considered in FDA's determination whether or not a warning letter is warranted.
Both of these developments are/were specific agenda items and part of Commissioner Hamburg's "get tougher" enforcement strategy, which also includes an increasing emphasis on federal, state and local cooperation; better preparation to deal with significant public health risks; and closer monitoring of "corrective" responses to Warning Letters and a formal procedure for the "closing out" of corrective activity including recalls.
FDA will continue to seek and evaluate "comments and scientific data and information on acrylamide levels in foods into 2010. Focusing on "plant-based foods, notably potato products ... coffee; and cereal-grain-based foods," FDA seeks input on "Methods of Reducing Acrylamide Levels in Food" and "Levels of Acrylamide in Food" because "FDA is considering issuing guidance for industry on reduction of acrylamide levels in food products."
In 2009, the Food Safety Working Group announced its findings and recommendations with regard to public health hazards, salmonella, E. coli, and product specific Guidance, i.e., leafy greens. In 2010, the food industry should be alert for additional FSWG findings particularly in the area of product tracking, updating FDA statutory authority; and centralized command of food safety responsibilities.
Early 2009 congressional activity in food safety and updating of the underlying FDA statutory authority was pushed aside by concerns about health insurance and related reform activity. Nevertheless, as this congress continues into 2010, the work done to date can be re-energized at any time and become the basis of a renewed push for increased and new FDA authority and enforcement power. The more significant issues which seem to appear in all bills proposed for consideration include, a HACCP-like program requirement for all food facilities, domestic and foreign, focusing on identification and prevention of health and food safety hazards; a risk-based facility inspection regimen - "higher risk" facilities receiving greatest attention and inspection frequency, domestic and foreign; new and enhanced records inspection authority, including an affirmative obligation to notify or give electronic access to FDA; country of origin labeling; annual facility registration with the right to suspend registration, domestic and foreign; increased penalties for criminal violations (knowing violations) as well as increased civil penalties under a strict liability standard as well as a "knowing" standard; product hold and mandatory recall authority to FDA; stricter regulation of imports including certification, product testing, and "good importer" status; and industry paid fees for registration and facility re-inspections.
The USDA/FSIS continues to consider "natural." An Advanced Notice of Proposed Rulemaking has requested additional input on specific follow-up questions with its request for comments. Is a hard and fast rule in the form of regulation the best approach, or should a more flexible approach be adopted which would allow producers to define their use of "natural" with additional disclosures on the product label? Should a definition of "natural" distinguish between ingredients used for antimicrobial effects from ingredients used as preservatives? How should "minimal processing" be defined in an era of advancing science and techniques of food processing? Is a carbon monoxide atmosphere packaging system "natural"?
In 2009 and certainly extending into 2010, marketers and consumers alike are interested in "green" and other environmentally beneficial claims. This phenomenon has not gone unnoticed by regulators. The FTC demonstrated its continuing interest by holding workshops to review for purposes of updating, its "Green Guides" or Guides for the Use of Environmental Marketing Claims; and, by closing enforcement actions based upon use of the term "biodegradable" in packaging but otherwise non-food applications. The Green Guides have been effective in defining terms like "biodegradable" and "recyclable," and the terms have attained a broad acceptance. However, the FTC is concerned that terms like "green"; "eco-friendly"; "sustainable"; and "carbon neutral" are working their way in the vernacular and may be lacking a consensus or understanding of these terms as applied by marketers and as heard by consumers. While the FTC's authority is limited to enforcement actions against deceptive and unfair practices, the Green Guides, if updated to include terms like "sustainability" will give consumers and marketers alike a common definition and understanding with which to communicate with each other.
Organic claims on food labels, which have for some time been regulated by USDA under its National Organic Program (NOP) are increasingly appearing on personal care products. Personal care products are not under the authority of USDA, and in a late 2009 policy statement, the USDA stated, "(it) is not currently enforcing this in the area of personal care products." However, the statement does recommend amendments to 7 CFR Part 205 (the organic standards program) to define certain terms including the term "organic" and use of the USDA organic certification seal.
Finally, food marketers who use endorsements and testimonials in advertising must be aware of significant changes made in the FTC's Guides on Endorsements and Testimonials. The guides are most easily understood by referring to the examples at the end of each of the regulatory sections which cover both consumer and expert endorsements. The changes may impact most directly those marketers who use "results not typical" or other wording to disclaim typicality or to alert hearers that their individual results may not be typical. The new Guides will require any marketer who claims "results may not be typical" to state "clearly and conspicuously" what a typical result would be. The advertiser should either "clearly and conspicuously disclose what the generally expected performance would be ... or clearly and conspicuously disclose the limited applicability of the endorser's experience. .."
Much of the momentum in 2009 surrounding food safety and related issues may have been lost to other perceived more pressing issues of the day but food companies should be vigilant in 2010 to the reawakening of old issues and the emergence of new opportunities and challenges.
From the January 4, 2010, Prepared Foods E-dition