FDA Issues Gluten Free Labeling Compliance Guide

Nearly a year ago on August 5, 2013, we reported on the blog that the Food and Drug Administration (FDA) had published a final rule establishing a regulatory definition of the term “gluten-free” for voluntary use in the labeling of foods. The final rule is intended to provide a uniform definition of the term “gluten-free” so that consumers, particularly those who have celiac disease, will know what it means when they see it on the labeling of food.

The rule became binding and effective on September 4, 2013, but August 5, 2014 is the date when FDA-regulated foods labeled “gluten-free” must comply with all requirements established by the final rule. In preparation of the upcoming compliance date, FDA prepared a Small Entity Compliance Guide which restates in plain language the requirements concerning use of the term “gluten-free” in the labeling of foods.

Specifically, the guidance states that any label claiming that a food is “gluten-free” must not contain any of the following ingredients:

  • An ingredient that is a gluten-containing grain (such as wheat, rye, or barley or any of their crossbreeds); or
  • An ingredient that is made from a gluten-containing grain and that has not been processed to remove gluten. For example, “wheat flour” is an ingredient made from wheat that has not been processed to remove the naturally occurring gluten in wheat. Therefore, wheat flour cannot be used as an ingredient to make a food labeled “gluten-free;” 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.

The claim can also appear on the labels of foods that inherently do not contain gluten, such as fresh vegetables or juices.

Another important bit of information is that, unlike other required label components, there are no requirements for color, type size or placement of the “gluten- free” claim.

Although the rule does not expressly require manufacturers to test for the presence of gluten in the raw ingredients or finished foods labeled “gluten-free,” it might be wise to do so. Failing to ensure that the food item bearing a “gluten-free” claim meets the requirements of the rule could cause the product to be deemed misbranded and thus subject to FDA regulatory action. In its guidance, the agency encourages companies to use effective measures to ensure that any foods labeled as “gluten-free” comply with the requirements including:

  • testing the ingredients to determine their gluten content;
  • requesting certificates of gluten analysis from ingredient suppliers; or
  • participating in a third-party gluten-free certification program.

However, as with all agency guidance, FDA’s compliance guidance for gluten-free labeling does not establish legally enforceable responsibilities. Instead, this guidance describes the agency’s current thinking on a topic and should be viewed only as a recommendation. If you have any questions about gluten-free labeling or other food label claims, contact Stoel Rives label compliance experts Claire Mitchell and Anne Glazer.

Oregon to Adopt 2009 FDA Food Code

The Oregon Public Health Division’s (OPHD) Foodborne Illness Prevention Program announced that it is moving forward with the adoption of the 2009 Food and Drug Administration (FDA) Food Code.  The new rules will take effect on September 4, 2012. Oddly, however, the agency noted that it would not be adopting the “No Bare Hand Contact” section of the Food Code.

In creating the “No Bare Hand Contact” rule for food handlers, the FDA pointed out that when hands are heavily contaminated, even effective handwashing practices may not be enough to prevent the transmission of pathogens from the hands to ready-to-eat (RTE) foods, such as sandwiches, salads, and other foods that are eaten without further washing or cooking. Accordingly, the rule requires the use of “suitable utensils such as scoops, spoons, forks, spatulas, tongs, deli tissue, single-use gloves, or dispensing equipment” when handling RTE food items to reduce foodborne illness.

Discussion of implementing the “No Bare Hand Contact” rule in Oregon was met with fierce opposition by restaurateurs who raised concerns over the cost of complying with the rule and whether it would actually increase food safety. In response, OPHD explained that over the next few months it will assemble a workgroup of interested parties (restaurateurs, government inspectors, consumers, etc.) to review and provide recommendations on addressing norovirus and fecal contamination of food, and to identify the best options to reduce illness.

Oregon’s process of adopting the 2009 FDA Food Code began in August 2010 when a Food Code Review Workgroup was established to work with the Oregon Department of Agriculture, food service and retail industry groups and regulators to develop recommendations regarding the new rules. Earlier this year, OPHD also provided training for regulators and industry on the 2009 Food Code in preparation for the September effective date.

The Association of Food and Drug Officials (AFDO), under contract to the FDA, has been gathering data on the progress of FDA Food Code adoptions by States, Territories, Local and Tribal Nation agencies. AFDO reported that 49 of the 50 States adopted codes patterned after the 1993, 1995, 1997, 1999, 2001, 2005, or 2009 versions of the Food Code, representing 96% of the U.S. population. Specifically:

  • Four States adopted the 1993, 1995 or 1997 Food Code, representing 4% of the US population.
  • Ten States adopted the 1999 Food Code, representing 13%of the US population.
  • Eleven States adopted the 2001 Food Code, representing 38% of the US population.
  • Twenty one States adopted the 2005 Food Code, representing 39%of the US population.
  • Three States adopted the 2009 Food Code, representing2% of the US population.

In September, Oregon will join Mississippi, New Hampshire, and Delaware in adopting the 2009 version of the food code. Until the final rules take effect, food industry members can review the Fact Sheets provided by OPHD to ensure compliance and see what other changes may affect their business in the coming weeks.

Canada Proposes Single Food Safety Inspection Model

In May 2012, the Canadian Food Inspection Agency (CFIA) published a report called The Improved Food Inspection Model: The Case for Change which outlined the agency's current approach to food inspection, the context for a new food inspection approach, and the proposed components of an improved food inspection model.

The report explains that when CFIA was first established in 1997, it brought together food inspection programs from different federal departments with diverse inspection approaches. As a result, CFIA currently administers eight, separate food inspection programs including:

  • dairy
  • egg
  • fish and seafood
  • fresh fruits and vegetables
  • imported and manufactured food
  • maple
  • meat
  • processed products (including honey)

Without a standardized food safety inspection model, CFIA has struggled to provide consistent oversight of all regulated food. According to the CFIA report:

Having eight food programs has resulted in the development and use of different risk management frameworks, inspection methods, and compliance verification and enforcement approaches. This challenges the CFIA to manage risks consistently across different types of establishments and different foods. It creates situations in which foods of similar risks may be inspected at different frequencies or in different ways. The eight food programs also result in industry having to meet multiple and different requirements that are challenging to address.

The challenge of maintaining eight different inspection programs coupled with changing methods of global food production, processing and distribution has necessitated the development of an improved and standardized food inspection model.

Earlier this month, CFIA drafted a proposal for a single food inspection model based on risk and prevention of non-compliance that would replace the eight food inspection programs the agency currently operates. The new model has five key components:

  1. Licensing/registration – A licensing and registration requirement for regulated parties that import or export food or that manufacture or process food for trade between provinces;
  2. CFIA oversight – Varying levels of CFIA oversight that would be based on the level of risk;
  3. Inspection – A systems approach to inspection that would assess the preventative control plans and procedures of regulated parties to ensure that food is prepared safely and complies with regulations;
  4. Compliance and enforcement – One common compliance and enforcement strategy for food; and
  5. System performance – Mechanisms to evaluate the CFIA’s inspection program for consistency, effectiveness and performance.

CFIA is hopeful that an updated food inspection system will benefit the food industry in a number of ways. For instance:

Inspection modernization will improve market access and give Canadian companies the flexibility to design controls that demonstrate their operations and products comply with all relevant federal standards. It will also create a more level playing field for businesses by streamlining the inspection process into a single system and eliminating the need for businesses to address multiple requirements.

In addition, the new model is also intended to increase transparency thus providing consumers with greater confidence in the safety and wholesomeness of their food.

The CFIA is seeking comments from the public including consumers and industry stakeholders until October 31, 2012 on the proposed draft model and intends to organize extensive outreach activities with CFIA inspectors, consumer associations, industry, and federal, provincial and territorial government counterparts in the fall. 

More on FSMA and Food Safety Risk Avoidance

Thank you to Parker Smith & Feek for inviting me to speak to about FSMA and how it’s changing the status quo. My slide-deck can be viewed here.

Following my talk, Marty Bask from Parker Smith & Feek led a very interesting discussion about the pros and cons of product recall and contamination coverage. A link to our recent discussion on this blog on what to ask when purchasing this kind of coverage is here.

FDA Issues Warning on Alcoholic Energy Drinks; States Move to Ban "Blackout in a Can"

Note: The following is authored by guest blogger Jake Storms, from the Alcoholic Beverages Law Blog.

Amidst rising incidences of hospitalizations in college and teenage drinkers linked to consumption of alcoholic energy drinks, the Washington State Liquor Control Board banned their sale effective tomorrow, November 18, 2010. The move came on the heels of a request by Washington Governor Christine Gregoire, whose office stated in a November 10 press release that they were “…particularly concerned that these drinks tend to target young people.”

The Liquor Control Board placed the ban in an emergency ruling which will last for 120 days. During that time, the Liquor Control Board will move to make the ban permanent. Liquor Control Board Chairperson Sharon Foster stated, “[t]he Board is acting in the public safety…the Board is acting now to ensure these products do not contribute to a tragedy before the Food and Drug Administration or Legislature can act.” Earlier this year, the Liquor Control Board had lobbied for State legislative action to ban the sale of caffeinated malt beverages in Washington but those efforts were unsuccessful. A list of particular products affected by the Liquor Control Board’s ruling can be seen here.

Washington’s ban is merely the most recent action in an ever increasing movement by states to control the sale of caffeinated alcoholic beverages. The Oregon Liquor Control Commission Chairman stated in an October press release that, “…alcoholic energy drinks should be removed from the market until further research isdone.” The OLCC also stated that it is currently looking into possible regulatory efforts with the state legislature and is reaching out to community organizations to warn them of the dangers of the beverages.

While California’s Department of Alcoholic Beverage Control has not yet made a statement regarding the drinks, Connecticut announced Monday that it had reached agreements with state distributors to voluntarily stop shipments of caffeinated alcoholic beverages starting December 10, 2010. Michigan has banned one particular brand of caffeinated alcoholic beverage, Four Loko. New York has reached an agreement with Phusion Projects LLC, the manufacturer of Four Loko, to stop sales in the state until “…emerging science, regulatory developments or other relevant changes in circumstances arise." Utah and Oklahoma have followed Washington’s lead in banning the sale of any brands altogether. Massachusetts’ Alcoholic Beverage Control Commission stated that it will file an emergency ruling, similar to Washington’s, on Monday, November 22, 2010.

At the federal level, the Food and Drug Administration (“FDA”) is currently reviewing whether caffeine is a safe additive to alcoholic beverages. A negative finding would essentially ban the sale of caffeinated alcoholic beverages nationwide. It is widely assumed the FDA will, in fact, reach a negative finding. NY Senator Chuck Schumer, who has been lobbying for a ban on the drinks, stated that the FDA decision “…should be the nail in the coffin of these dangerous and toxic drinks.” The FDA decision is expected within the week.