By Tara McCarthy, MS RD LDN, The Celiac Disease Program, Boston Children’s Hospital
What has changed: In May 2020, the US Food and Drug Administration (FDA) came out with a temporary policy guidance to be used for ingredient substitutions due to disruptions in supply or food shortages during the pandemic. Specifically, manufacturers will be temporarily allowed to make minor ingredient substitutions without full disclosure or making changes to the ingredient label. The aim is to provide flexibility for manufacturers so that the food supply is stable. The full document has many good examples of substitutions. It is important to gather all the facts first and see how this could be worrisome for those patients with celiac disease before we start to stress.
The role of the FDA is to ensure safety of the food supply and they have clearly indicated that allergens, including gluten, are safety concerns. This is reiterated throughout the document and the FDA is telling manufacturers that they should not make substitutions that would cause an “adverse health effect”. In the policy, the FDA outlines general factors for manufacturers to consider, including:
- “SAFETY: the ingredient being substituted for the labeled ingredient does not cause any adverse health effect (including food allergens, gluten, sulfites, or other ingredients known to cause sensitivities (see section C.2.a) in some people, for example, glutamates);
- QUANTITY: generally present at 2 percent or less by weight of the finished food;
- PROMINENCE: the ingredient being omitted or substituted for the labeled ingredient is not a major (prominent) ingredient (for example, replacing rice flour for wheat flour in a muffin) or an ingredient that is the subject of a label statement (such as, butter in a cookie with a “Made with real butter” claim)
- CLAIMS: an omission or substitution of the ingredient does not affect any voluntary nutrient content or health claims on the label”
This is the only mention of gluten in the document, as later the recommendations refer to substitutions that would cause “an adverse health effect”. The section on claims means that gluten should not be added to products with a gluten-free claim.
The FDA is concerned that consumers be notified of changes even if they can’t tell by reading the label. “For transparency and consumer awareness, we recommend that manufacturers use alternative ways, such as posting information to their website or through point of sale labeling, to communicate to consumers any changes, such as ingredient omissions or substitutions, that are not reflected on the product label”. The document uses the words should or recommend which means it is suggested or recommended but NOT required per the document.
Looking at the temporary changes made, it also discusses guidelines that have not changed. The guidance also specifically references the food labeling law Consumer protection act (FALCPA) also known as section 201(qq) of the Food Drugs and Cosmetics Act (FD&C). This law already protects the consumer for the top 8 allergens this includes wheat (very important for the celiac community), soy, dairy, eggs, fish, shellfish, peanuts and tree nuts.. In addition, per the document:
“Avoidance Considerations In addition to the eight major food allergens defined at section 201(qq) of the FD&C Act, several other foods (such as sesame, celery, lupin, buckwheat, molluscan shellfish, and mustard) are recognized as priority allergens in other parts of the world including Canada, European countries, and Japan. There are also other ingredients (such as glutamates and sulfites) that can cause adverse reactions. Manufacturers should avoid substitutions that could result in a safety concern without making a conforming label change or providing other means to inform consumers of the change.”
As far as cross contact and the voluntary labeling such as made in a facility or may contain for allergens, these claims are NOT regulated and cannot be used to determine if a product is safe or not. This has NOT changed with this new temporary policy. You can and SHOULD always contact the company.
To summarize our recommendations:
- Always Read the labels and double check the products each time you buy them. Products change; with this temporary policy this may not be enough so we encourage families to call companies.
- Look for products labeled Gluten Free. If a product claims it is GF then the manufacturer is claiming that it contains less than 20ppm gluten.
- Contact the company with any questions and be specific.
Happy Handwashing! Stay healthy, safe and Gluten Free!