By Chip English and Cary Greene

FDA has at long last adopted formal and final rules regarding the voluntary labeling of products as being “Gluten-Free.” While the rules announced on August 2 will not be enforced until September 2014, we recommend strongly that anyone making or wishing to make this voluntary label claim should treat the FDA announcement as being immediately effective. Why? First, and as always most importantly, your customers will expect and demand it. Get ahead of the competition. Second, the best defense in this litigation heavy universe regarding food labeling is to go on offense – adopting the FDA approach may well insulate you against claims that your label is false or misleading.  This is especially true here since FDA has asserted that the new rules preempt contrary state law.

While the rules do not technically govern restaurants, FDA has advised that “restaurant menus should be consistent with” the standards set out by the new rule.  In other words, restaurants that ignore the FDA rules do so at their own risk, while restaurants that conform theoretically enjoy some of the benefits as manufacturers subject to the rule.

What are the most important FDA provisions? 
  • The choice to label a gluten-free product is yours, not the government’s. No one is required to make the claim and entities that cannot are not required to label the presence of gluten.  
  • There’s a tolerance level of 20 parts per million: below that threshold and gluten-free claims are permitted; above that threshold (for any reason including cross contamination) and claims are prohibited.
  • FDA does not test your products, so you will need to have your own internal verification methods. For restaurants, that’s probably somewhat complicated, but if your marketing strategy is tied to specific gluten-free claims, make sure you can consistently back them up.
  • FDA does not proscribe the text or location of the voluntary claim on your label so you can use your own language to inform your consumers that a product was produced without gluten or has no gluten.
Reducing risk is important because class action lawyers presently are fixated on our industries. Litigation over false or misleading claims is expensive and distracting and is most often not covered by traditional insurance policies.