Regulatory Issues: A proposed rule is not a final rule
FDA recently confirmed its reversal on “and/or” wording in ingredient statements.
By David Joy, Contributing Editor | 09/23/2005
FDA recently wrote to soft drink manufacturers regarding the use of “and/or” labeling to identify nutritive sweeteners in the ingredient declaration on product labels. This letter clarifies that nutritive sweeteners present in soft drinks, such as sucrose or high fructose corn syrup (HFCS), must be specifically identified in the list of ingredients. The use of “and/or” labeling to identify two or more sweeteners is not acceptable.
It’s worth reviewing the long and unusual history of this issue, as it contains a few lessons of general interest.
More than 20 years ago, the National Soft Drink Assn. (NSDA) petitioned FDA to allow the identification of these sweeteners using “and/or” ingredient labeling. FDA initially denied this petition in 1991, but then reconsidered the matter and published a proposed regulation in 1993 that would have authorized the practice. In 1997, FDA wrote to NSDA stating that the agency would not take enforcement action against soft drinks that used “and/or” labeling for nutritive sweeteners while the rulemaking was pending.
In 2004, FDA withdrew its proposed rule to grant NSDA’s petition. Many other proposed rules were withdrawn at the same time because they were old and no longer considered viable candidates for final action based on FDA’s limited resources and changing priorities. FDA’s recent statement on the issue clarifies that the agency’s 1997 letter regarding enforcement discretion is no long operative. The matter is closed, and NSDA’s original petition is once again denied.
The Food, Drug, and Cosmetic Act states that if a food is made from two or more ingredients, its label must bear the common or usual name of each ingredient. The act also authorizes FDA to establish exceptions if compliance with this requirement is impracticable or results in deception or unfair competition. It is difficult to picture a situation in which the specific listing of every ingredient would result in deception or unfair competition. Thus, “and/or” ingredient labeling can be permitted by FDA primarily in situations where it would be “impracticable” for food manufacturers to identify only the specific ingredients that are present.
According to FDA’s 1993 proposal to grant NSDA’s petition, the soft drink industry made a reasonably strong case that listing the specific sweetener(s) present in soft drinks on the label is difficult. It was said that the soft drink industry uses HFCS and sucrose interchangeably. When HFCS is in short supply, a bottler will use sugar or a blend of sugar and HFCS. If “and/or” labeling is not permitted, the bottlers would apparently need to maintain three separate versions of labels and cans: one that identifies HFCS as the sweetener, one that identifies sugar, and one that identifies both.
The question presented to FDA was, essentially, whether the additional cost and effort associated with three different versions of packaging and labels made it “impracticable” for the soft drink industry to declare each ingredient by its common or usual name. When FDA proposed to permit “and/or” labeling in 1993, the agency expressed some reservations and requested further information from the soft drink industry regarding the impracticability of maintaining different versions of labels and packaging. FDA also noted that most other “and/or” labeling exemptions cover minor ingredients, normally present at less than 2% of the finished food.
At least two observations emerge from this story. First, the statutory criteria by which FDA may grant “and/or” exemptions for ingredient labeling are a bit vague. It is never truly impossible to provide a list of ingredients actually present in the product. The question is whether maintaining three or more different sets of labels is a significant enough hardship that the exemption should be granted, and this may be a difficult call to make.
Second, when FDA issues a proposed rule to grant a petition, do not consider the matter resolved until the final rule has been published. Given FDA’s letter of enforcement discretion, the soft drink industry probably did not consider it a big priority to see the final rule published promptly. Unfortunately, the passage of time eventually lessened the likelihood that FDA would ever issue the final rule, and it has now been withdrawn along with a surprisingly large number of other rulemakings that once occupied significant time and resources but eventually fell victim to the agency’s short attention span.
is a partner at the Washington, D.C. law firm of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides, and medical devices. He is a member of the District of Columbia Bar and holds a bachelor’s degree in chemistry. For more information about Keller and Heckman, visit the firm’s web site at www.khlaw.com