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Guidance for Industry & Consumers in Navigating Confusing “Gluten-Free” Terminology

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Gluten-free” is big business. Presently, approximately 1 percent (or 3 million) of Americans suffer from celiac disease, while 6-7 percent (18 to 21 million) experience a non-celiac gluten-sensitivity, and others opt for a gluten-free lifestyle for health or personal reasons. By some counts, nearly 30 percent of the U.S. population, accounting for 90 million Americans, is actively trying to live a gluten-free lifestyle.

And the market has responded. Research shows gluten-free customers typically spend $100 with their average grocery basket, as compared to $33 for the overall average basket. By 2020, the global gluten-free market is projected to be valued near $7.6 billion, up from $1.7 billion in 2011.

But “gluten-free” terminology can be confusing for consumers and companies alike. In 2013, the U.S. Food and Drug Administration (FDA) adopted regulations governing the voluntary labeling of food as “gluten-free.” 21 C.F.R.§ 101.91. While the regulations do not require use of the term “gluten-free” on food labeling, if companies choose to do so, then requirements for use of the claim must be satisfied. To be labelled “gluten-free,” the gluten content must be below 20 parts per million (ppm) gluten, or below 20 milligrams (mg) gluten per kilogram (kg) of food.

The FDA expressly declined to require a particular symbol or logo be used to label foods “gluten-free,” citing the existence of third party gluten-free certification programs and companies that have designed unique symbols for identifying gluten-free foods.

Therefore, consumers must understand “gluten-free” may not mean a product is completely free of gluten. Instead, levels of gluten up to 20 ppm are marketed across the industry, and some have developed their own “gluten free” symbols possibly as a mechanism to avoid regulatory restrictions.

To help companies and consumers navigate the confusing “gluten-free” space, gluten-free certification organizations exist to meet the consumer demand for specificity in gluten-free terminology. For example:

<> Gluten Intolerance Group of North America (GIG) owns the Gluten-Free Certification Organization (GFCO), an international certifying body that is the largest in North America. See gluten.org. GFCO is an accredited certifying body that certifies food products as containing less than 10 ppm gluten, and permits certified products to bear GFCO’s certification mark on product labeling, notifying consumers that products bearing its mark have satisfied and remain subject to GIG’s certification scheme.

<> NSF International (NSF) is a worldwide organization that certifies many types of products and services. See nsf.org. NSF is an accredited certifying body that requires certified products to contain 15 ppm gluten or less, and permits certified products to bear NSF’s certification mark.

<> The Gluten-Free Certification Program (GFCP) is owned by the Allergen Control Group, Inc. (ACG). See glutenfreecert.com. GFCP has a presence throughout the United States and

Canada, and is an accredited certifying body that requires food products to contain less than 20 ppm gluten. GFCP permits such products to bear its certification mark. Beyond Celiac is a non-profit organization that endorses the GFCP and permits certified food products containing less than 20 ppm gluten to bear its certification mark.

To compete in this space, some companies have developed their own “self-certifications” to “certify” their own products as “gluten-free.” But companies and consumers should be wary of self-certifications.

The International Accreditation Forum (IAF), a global network of accreditation bodies and organizations involved in conformity assessment activities, explains:

Without the certification body, there’s no unbiased appraisal and no evidence

that a thorough assessment has even been conducted by competent individuals.

Bottom line: There is no such thing as self-certification. It’s just an attractive

catchphrase with no substance… . An organization that “self-certifies” can’t

begin to demonstrate this rigor in terms of training, competence, performance,

or impartiality… . Bogus certifications and “self-certifications” devalue the

work of tens of thousands of organizations that have opted to have their

systems assessed and continually monitored by an impartial third party. They

undermine the entire conformity assessment community.

See http://www.iaf.nu/articles/SelfCertification_Is_Not_a_Real_Thing/391.

Likewise, the United States Federal Trade Commission (FTC) pursues enforcement actions against companies who offer misleading “self-certifications” by either not disclosing their connection to the certifying body (themselves or a closely-related entity), or by self-certifying without any independent evaluation or compliance monitoring and without disclosing that fact to consumers.

Companies may also find themselves liable to consumers for mislabeling products as “gluten-free.” For example, General Mills Inc. is still stuck in appeals following a 2015 class action lawsuit for mislabeling its Regular and Honey Nut Cheerios as “gluten-free,” after the company’s announcement that wheat flour inadvertently tainted cereal produced at one of its plants.

For all of these reasons, companies would be wise to follow the letter of the law in use of “gluten-free” terminology, and to contract with a gluten-free certification organization for a neutral and independent certification of their products as “gluten-free.”

Sally F. White is a Partner at Jeffers, Danielson, Sonn & Aylward, P.S., in Wenatchee, Washington. She practices in food product labeling and intellectual property law, and acts as outside general counsel for a large gluten-free certification organization.