"Over 50 million Americans suffer from allergies, and approximately 55 percent of all U.S. citizens test positive to one or more allergens."
The FDA is taking allergens seriously.
In 2004, FDA passed the Food Allergen Labeling and Consumer Protection Act, which applies to all food products and dietary supplements. "Section 201(qq) of the Act \[21 U.S.C. 321(qq)\] defines "major food allergens" as milk, egg, fish, Crustacean, shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils."
The ruling sounds straightforward enough, though in recent months, I've encountered the following discrepancies and disagreements regarding allergen labeling:
Spelt & wheat allergens
Recently, a pretzel received a Warning Letter from the FDA regarding allergy labeling that offers a valuable lesson.
"The U.S. Food and Drug Administration (FDA) recently reviewed the label for the seven ounce package of our product "(Product Name) SPELT PRETZELS" (Spelt Pretzels product). Based on our review of the product label, we have concluded that the Spelt Pretzels product is misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) \[21 U.S.C. § 343(w)\] because the label fails to declare the presence of wheat, a major food allergen, as required by section 403(w)(1)."
It is well known that spelt and wheat are two different plants. So, if there's no wheat, why did the FDA insist the spelt carry the wheat allergy warning?
Here's the FDA rationale:
"Accordingly, because your Spelt Pretzels product contains spelt, \[which is considered wheat for the purposes of section 201(qq) of the Act*\], and because your product label does not declare the presence of wheat in the product, your Spelt Pretzels product is misbranded within the meaning of section 403(w) of the Act."
Even though wheat is an entirely different plant from spelt, the FDA considers them in the same category:
"Your product label states that the product contains spelt, which is Triticum spelta L. The term "wheat" in section 201(qq) means any species in the genus Triticum. Thus, for the purposes of section 201 (qq), wheat includes grains such as spelt."
Glucosamine & probiotic supplements
There are other examples of labeling writing regarding allergens. I came across this interesting example when working on copy writing for a supplement that contains NAG (NAcetylGlucosamine).
The majority of glucosamine is made from shellfish, and therefore requires the shellfish allergy warning in the copy and on the label. But, some glucosamine is not derived from shellfish. In order to get confirmation about the shellfish in this product, it is essential to contact the manufacturer. Fortunately, for my client, this particular ingredient is made from fermentation, not from shellfish.
Another example of the need to watch your language, even when you think it's a waste of time or over-kill, is probiotics. I recommended that a probiotics products needed a milk allergy warning. The company disagreed, saying it was unnecessary. Again, I contacted the manufacturer, who confirmed the need for an allergy warning.
Allergies are a serious matter. It's easy to overlook allergen warnings on your labels, but if you watch your language, you'll remember to check the facts carefully. For more on allergen labeling requirements www.cfsan.fda.gov/~dms/alrguid4.html.
*(Italics are editorial notations.)