Background

The FDA received a citizen petition requesting that the FDA act to protect consumers with celiac disease by better enabling them to identify, through labeling, whether a food includes gluten-containing grains (GCGs), and to address cross-contact with GCGs. FDA subsequently reviewed available data and reports, which indicated that serious data gaps are limiting the agency’s ability to fully evaluate the public health importance of these ingredients, including data on adverse reactions.

Request for Information

The FDA is taking this action as a first step to improve transparency in disclosures of ingredients that impact certain health conditions, such as gluten for those with celiac disease, and other established food allergens.

The agency is inviting comments concerning adverse reactions due to “ingredients of interest” ( i.e., non-wheat GCGs and oats) in the United States. The RFI also aims to collect data on labeling issues or concerns with identifying ingredients of interest on packaged food products in the United States.

The FDA is particularly interested in:

• Data and information on IgE-mediated and non-IgE-mediated food allergies and adverse reactions to non-wheat GCGs (including prevalence, severity, and potency).
• Data and information on gluten in oats (including frequency and amounts of gluten in oats), and the prevalence, severity, and potency of IgE-mediated and non-IgE-mediated allergy and adverse reactions to oats.
• Data and information on undisclosed ingredients of interest (including their prevalence and usage amounts in food products and adverse events resulting from consumption of these food products).
• Data and information related to ingredients of interest, including potential consumer perspectives and experiences.

Interested parties may submit information through the regulations.gov electronic filing system or by mail through March 23, 2026.

Learn more:

• Webinar: FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions
• Webinar: Getting MoCRA Compliant
• ICYMI: FDA Launches Nationalized Entry Review Program (NER)
• FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling
• FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling
• FDA Helps Small Businesses Get Ready for New “Gluten-Free” Labeling Requirements
• FDA Finally Issues Definition of “GLUTEN FREE”!
• Gluten Free Labeling is Coming – But, First, FDA Wants to Hear From YOU!!!!

In response to the increase in enforcement discussed below, Diaz Trade Law is hosting a NEI accredited webinar, FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions to train industry on top compliance tips to avoid enforcement, and best practices in responding to various FDA enforcement.

Why Should Industry Register for the Webinar?

Warning Letters in 2021:

• Just yesterday, FDA teamed up with the Federal Trade Commission (FTC) to publicly admonish 5 companies with warning letters for illegally selling dietary supplements claiming to treat infertility because FDA advised the products are unapproved drugs.
• Since the beginning of 2021, alone, the FDA has already issued 260 warning letters. 55 of those warning letters were issued against firms, including cosmetic firms, for selling unapproved drugs that are misbranded or adulterated or selling unapproved and misbranded products related to COVID-19.

Import Alerts in 2021:

• FDA has 208 active import alerts. Since the beginning of 2021, the FDA has already updated 74 import alerts to add new violators. 4 of the 74 import alerts are specifically for unapproved drug violations:

• FDA has updated Import Alert 66-41 a total of 274 times since the beginning of 2021, with the most recent update on May 6, 2021. This import alert lists 379 violative cosmetic products which are (because of their claims) unapproved drugs. This import alert will be discussed in detail at the webinar. The speedy increase in the number of firms subject to the this import alert indicates that manufacturers, importers, and distributors of cosmetic and over-the-counter drugs must review their labeling and pre-compliance protocols to avoid being targeted by the FDA.
• Important to note that on February 25, 2021, FDA published Import Alert 62-08, which allows for the “Detention Without Physical Examination of Alcohol-Based Hand Sanitizers Manufactured in Mexico.”

This one-hour webinar will provide an overview of FDA regulatory enforcement actions. Our international trade attorneys will discuss top labeling dos and don’ts to lower your risk of FDA enforcement, while offering best practices. You will learn about FDA regulations and laws pertaining to over-the-counter (OTC) drugs and cosmetics marketed in the United States. The presentation will discuss real case scenarios. The objective of the webinar is to teach manufacturers, importers, and the like, how to navigate FDA’s regulatory framework, provide TOP compliance tips to avoid FDA enforcement actions, and top strategies to implement when you are faced with an enforcement action.

Manufacturers, importers, distributors, and others engaged in the production or sale of Over the Counter (OTC) drugs or cosmetic products are encouraged to attend our one-hour webinar, “Is it a Cosmetic, a Drug, or Both? FDA Enforcement Actions” either live on June 9, 2021 at 12:00 PM, or on demand thereafter.

Diaz Trade Law’s president, Jennifer Diaz, accompanied by DTL’s Associate Attorney Denise Calle, will be our featured speakers. Importers, exporters, brokers, and others interested in trade policy are encouraged to attend. REGISTER HERE!

Wheat Stalk 100% Gluten Free Label Vector Illustration

According to the FDA, approximately 3 million people (or 1 in 133 people) in the United States have celiac disease (CD), including me. While there is currently no cure for CD, unfortunately, individuals who have the disease are advised to follow a strict gluten-free diet. Over time, the continued ingestion of gluten by Celiacs triggers the production of antibodies that attack and damage the lining of the small intestine. Such damage hinders the absorption of nutrients, which leads to an array of severe health issues. This makes truthful gluten-free labeling essential for a Celiac’s survival, and celiac’s like me ecstatic that the “gluten-free” claim will be enforced, come August 5, 2014. If you manufacturer a food product, and are not ready to comply, read on.

On August 5, 2013 the FDA published a rule final rule that established a definition the term “gluten free” for voluntary use in the labeling of foods, see my previous blog post on this here. This will enable Celiacs to trust food products that are labeled “gluten free.” With the compliance date, August 5, 2014, fast approaching, the FDA has now provided a guide to help small businesses comply with the new federal requirements for “gluten free” labeling.

The guide sets forth (in plain language) the requirements set forth in the final rule and defines the following terms:

• Gluten – the proteins that naturally occur in a gluten-containing grain and that may cause adverse health effects in persons with celiac disease.
• Gluten-containing grain – any one of the following grains or their crossbred hybrids (e.g., triticale, which is a cross between wheat and rye):
  • Wheat, including any species belonging to the genus Triticum;
  • Rye, including any species belonging to the genus Secale; or
  • Barley, including any species belonging to the genus Hordeum.
• Gluten-free – food that does not contain any of the following ingredients:
  • An ingredient that is a gluten-containing grain; or
  • An ingredient that is made from a gluten-containing grain and that has not been processed to remove gluten;  or
  • An ingredient that is made from a gluten-containing grain and that has been processed to remove gluten, if the use of that ingredient contains 20 parts per million (ppm) or more gluten.
    • This means that foods may not use the claim if they contain 20 ppm or more gluten as a result of cross-contact with gluten-containing grains or other gluten-containing ingredients. 20ppm is equivalent to 20 milligrams of gluten per 1 kilogram of food.

According to the guide, the “gluten-free” claim can appear anywhere on the product, in any size or color.

After August 5, you are responsible for ensuring that your foods bearing a gluten-free claim meet the FDA requirements, including that any unavoidable gluten present in a food labeled “gluten-free” is less than 20 ppm. Failure to ensure your “gluten-free” labeled products meet the FDA requirements is considered  “misbranding” and can subject you to civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Penalties for non-compliance with FDA labeling requirements (misbranding) range from $1,000 to $10,000 fines and up to 3 years in prison.

All products must be labeled in accordance with the regulations in the FD&C Act.  If you are not sure if your product is in compliance, and you mention this blog post, contact me at 305-260-1053 or jdiaz@bplegal.com,  and receive a complimentary consultation to discuss your labeling! Hurry, August 5 is around the corner!

Co-Authored by Melissa Rodriguez, a law clerk at Becker & Poliakoff and a student at the University of Florida Levin College of Law.

My sincere hope is FDA will now test imported products that make “GLUTEN FREE” claims, and assure these companies are legitimately using the gluten free claim.  Meaning, I hope FDA will enforce and penalize those that are importing misbranded product and not correctly utilizing the gluten free claim!  The enforcement tools I will look for include FDA detaining imported product making gluten free claims, and sending them to FDA’s own laboratories to check the parts per million of gluten in the product.  If the product contains more than 20 parts per million of gluten, FDA should refuse admission of the product – meaning it would need to be exported or destroyed within 90 days of the refusal, otherwise, companies would face a liquidated damages claim. I also hope FDA will take the added step of adding non-compliant companies to the FDA’s Import Alert (black list) so that the products are AUTOMATICALLY stopped before entering the U.S. and the importer is forced to prove compliance prior to getting FDA to release the goods.

The “Compliance Date” for this final rule is August 5, 2014. If consumers see products labeled “gluten free” we should be able to TRUST that those products legitimately do not contain gluten. Now, we have a standard. Products labeled gluten free must contain LESS than 20 parts per million of gluten to be legitimately labeled so.

This is a fantastic start!!! Here’s what the FDA had to say, and the actual FINAL RULE is included as a hyperlink at the end.

FDA defines “gluten-free” for food labeling
New rule provides standard definition to protect the health of Americans with celiac disease
The U.S. Food and Drug Administration today published a new regulation defining the term “gluten-free” for voluntary food labeling. This will provide a uniform standard definition to help the up to 3 million Americans who have celiac disease, an autoimmune digestive condition that can be effectively managed only by eating a gluten free diet.

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.”

This new federal definition standardizes the meaning of “gluten-free” claims across the food industry. It requires that, in order to use the term “gluten-free” on its label, a food must meet all of the requirements of the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.”

The FDA recognizes that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. Food manufacturers will have a year after the rule is published to bring their labels into compliance with the new requirements.

“We encourage the food industry to come into compliance with the new definition as soon as possible and help us make it as easy as possible for people with celiac disease to identify foods that meet the federal definition of ‘gluten-free’” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

The term “gluten” refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.

The FDA was directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which directed FDA to set guidelines for the use of the term “gluten-free” to help people with celiac disease maintain a gluten-free diet.

The regulation was published in the Federal Register.

1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
2. an ingredient derived from these grains and that has not been processed to remove gluten
3. an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten
4. 20 ppm (parts per million) or more gluten

1. choose “Submit a Comment” from the top task bar
2. enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. select “Search”