|September 25, 2013|
Previously published on September 20, 2013
Proposed legislation has been introduced by 3 members of the House, including Rep. Frank Pallone (D-NJ), senior Democrat on the House Energy & Commerce Health Subcommittee, which would direct the Secretary of Health & Human Services (HHS) to create a single, standard front-of-package labeling system for all food products that require labels.
The Nutritional Labeling and Education Act (NELA) of 1990 amended the FDCA to create a uniform system of food labeling. It mandated the “Nutrition Facts” panel which contains specific and highly regulated information. The front label, governed by a different section of the NELA, contains information that a food manufacturer may include.
The legislation, as explained by Rep. Pallone’s office, follows up on recommendations of the Institute of Medicine made in 2011.
The major provisions of the bill require the FDA to issue guidance and definitions:
- Clarifies the scientific support needed for a structure/function claim and gives the FDA power to compel production of the data that supports such claims;
- Update the definition of the term “healthy”;
- Establish a standard definition for the term “Natural”;
- Require disclosure of the amount of caffeine in a product if it exceeds 10 mg.
The bill specifically indicates that it does not apply to dietary supplements. This is not surprising as dietary supplements are governed under a separate regulatory regimen (DESHA).
Of the many questions raised by the proposed legislation, one may be which constituency will be at the head of the line opposing the bill: the FDA or the plaintiffs’ bar.
For example, the FDA has balked at defining the term “Natural” for several years. Recently, a Federal District Court judge in California has specifically ruled that the FDA should provide a definition of the term “Natural”.
Should the bill become law, plaintiffs’ attorneys will be faced with the defenses of Federal preemption and primary jurisdiction(issue should be determined by a Federal agency not the courts) that could result in an early dismissal of false advertising cases. Heretofore, those defenses have been met with middling success due to the FDA’s refusal to define with any specificity “healthy” and “natural”.
Some consumer groups have already lined up as supporters of the proposed legislation: Consumers Union (policy arm of Consumer Reports) and the Center for Science in the Public Interest. No food manufacturers have publicly stated a position on the bill, but support of a bill which requires the FDA to set forth a bright line definition of the terms that have been the source of numerous lawsuits across the country may be in their best interest.
The “strange bedfellows” phenomenon may once again be in play here.