An Allergen Warning
by Steven Shapiro, Esq.
The dietary supplement industry is facing a crisis on the issue of allergens, though there has been almost nothing of substance on this topic directed to the dietary supplement industry. If anyone believes the Food and Drug Administration (FDA) does not take allergens seriously, take a look at the recall list on the agency’s Web site (www.fda.gov); the vast majority relate to allergen issues.
A new law is soon to take effect that will make allergen labeling mandatory on foods and dietary supplements. On Aug. 2, 2004, the Food Allergen Labeling and Consumer Protection Act of 2004 (Title II of Public Law 108-282) was enacted. This law requires that conventional foods and dietary supplements labeled on or after Jan. 1, 2006, identify “major food allergens” contained in products.
It is therefore critical for companies to consider the impact of this new law on product labeling. Moreover, while the law appears simple at face value, it is actually quite complex and entails more than a mere glance at an ingredient list to confirm that a product is in compliance. In addition, FDA has chosen not to issue regulations to implement the allergen law. Instead, the agency issued a “Final Guidance” on Oct. 5, 2005, (www.cfsan.fda.gov/~dms/alrguid.html) in a questionand- answer format, with a statement that the agency expects to issue subsequent editions of the guidance with new questions and answers in the future. Unfortunately, the current guidance addresses a scant few of what we can expect industry’s questions to be. While this article is intended to offer some information on the new law, it does not address all of the potential issues. It is therefore important for any company that believes that its products may be affected to review the law for itself and, if necessary, obtain appropriate counsel from a lawyer or consultant.
For clarification, the term “major food allergen” refers to the eight most common allergens—milk, egg, fish (e.g., bass, cod, flounder), crustacean shellfish (e.g., crabs, lobster, shrimp), tree nuts (e.g., almonds, pecans, walnuts), wheat, peanuts and soybeans. This also means a food ingredient that contains protein derived from any of these described foods except “highly refined oils” derived from any of these foods—a term that is not defined or otherwise described in the law or in FDA’s Final Guidance—and a few other very narrow exceptions.
In order to conduct a complete allergen review on a product there are a number of steps that need to be taken. First, the ingredient list and/or supplement facts table needs to be examined to ensure all of the major allergens are identified by use of a common name. For example, the law requires casein and whey be labeled as “derived from milk.”
Also, less obvious sources of ingredients contained in a product must be examined, such as soy- or egg-derived lecithin, which must carry allergen identification. It’s the same situation if the product contains glucosamine from shrimp; the specific crustacean shellfish— shrimp—must be identified on the label.
The third part of an allergen review is, by far, the most difficult because it will likely involve contacting ingredient suppliers in order to search out “hidden” allergens. Companies that manufacture finished form dietary supplements may not be aware of the hidden allergens that can be contained in their products, and ingredient suppliers need to supply this information for product labeling purposes. Consider the fact that flavors, colors, binders, excipients and incidental additives that are, or that contain, any major food allergen must comply with the new allergen labeling law. If “natural flavors” in the ingredient list includes a tree nut, the name of the tree nut (e.g., “Contains Almonds”) must be indicated. If casein is a drying agent for a flavoring, the product it flavors must indicate that it contains milk. If a vitamin ingredient used in the product was made with a major allergen, perhaps as a binder, that allergen must appear on the label.
The law does not provide for a minimal level where a declaration would not be required. If any amount of a major food allergen is in the product, it must be declared on the label. In the Final Guidance, it states “FDA will at some point need to consider a threshold level for one or more food allergens in the context of reviewing a petition or a notification submitted to request that an ingredient be exempt from [the allergen law’s] labeling requirements.” Thus, it is possible that thresholds for disclosure may exist in the future, and it would certainly seem appropriate for interested companies to consider petitioning FDA for such thresholds.
As to the labeling requirement, under the new law, a food or dietary supplement will be misbranded if it contains an ingredient that bears or contains, a major food allergen, unless:
- The word “Contains”, followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients (e.g., “Contains peanuts”), or
- The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, e.g. “casein (a milk protein)”.
The FDA Guidance states if a company chooses to use the “Contains” format, the statement “must identify the names of the food sources for all major food allergens that either are in the food or are contained in ingredients of the food.” A product label cannot have some of the allergens in the ingredient list and some in a “Contains” statement.
The examples cited above used fish, crustacean shellfish and tree nuts for a specific reason. While acceptable allergen declarations are milk, egg, wheat, peanuts or soybeans (also soy or soya), the new law requires the specific species of fish, crustacean shellfish or type of tree nut(s) must be identified on product labels. “Contains Shellfish” will not be sufficient. This raises a major question: Can your company identify the types of fish in your fish oil or the crustacean shellfish species that supplied the cartilage?
Many products are currently labeled with a statement to the effect that the product “may” contain allergens, for example, “may contain peanuts”. Although FDA has not yet taken a position on this issue, such labeling is not likely to be acceptable under the new law. Either a product contains peanuts or it does not. FDA has stated a “may” statement is not an acceptable substitute for compliance with GMPs (good manufacturing practices). Certainly, companies may have to consider a number of GMP-related issues, including what steps will be necessary to ensure allergens do not otherwise “contaminate” a product that is not labeled as containing allergens. Anyone interested in allergen manufacturing issues should read FDA’s Compliance Policy Guide, “Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens,” for further information.
In this regard, the new law also gives FDA the authority to conduct inspections to ensure facilities comply with practices to reduce or eliminate cross-contact of foods with residues of major food allergens that are not intentional ingredients, and to ensure major food allergens are properly labeled on foods.
Our firm has been in contact with FDA on some of these allergen labeling issues. For example, it is our understanding that FDA’s Division of Food Labeling and Standards (DFLS)—the group leading the implementation of the Allergen Act—has taken the position that the new law requires companies list every fish species on the label used in a fish oil product. Interestingly, prior to our inquiry, DFLS had not been asked about how the law applies to fish oil. Most inquiries to DFLS have been from the shellfish industry about certain types of cartilage products. At this time, DFLS is expecting to issue subsequent guidance documents about the new allergen law; FDA has suggested companies with questions contact the agency in writing so any future guidance can best answer industry’s questions.
Fish oil provides a prime example of types of relevant questions that could be addressed to DFLS. How much residual fish protein is in fish oil? Are the proteins removable? Would removing the proteins alter the effectiveness of the fish oil? Are all fish oils the same? How is fish oil manufactured? What are the typical industry practices with regard to fish oil?
Obviously, with a Jan. 1 effective date, there is precious little time to influence FDA’s enforcement of this new law.
Steven Shapiro is a partner in the New York-based law firm of Ullman, Shapiro & Ullman LLP, which specializes in legal issues affecting the dietary supplement and natural products industry. He can be reached at (212) 571-0068; www.usulaw.com.