The Park Doctrine and Jensen Farms

Many were surprised by the recent arrest of the Jensen Farm’s owners for selling Listeria contaminated cantaloupes that caused 33 deaths (http://pennstatefoodsafety.blogspot.com/2013/09/jenson-brothers-growers-of-tainted.html). Introducing the Park Doctrine. All responsible company officials, whether their company is manufacturing food items OR distributing food items manufactured by someone else, should be aware of the implications. 

 From the FDA Law Blog – Feb 2, 2011 (reference below):

“… a corporate official can be convicted of a misdemeanor based solely on his position of responsibility and control to prevent the underlying violation of the FDCA. There is no requirement that the official acted personally in the wrongdoing, or that he even had knowledge of it. The Supreme Court determined that the FDCA “imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur.” Park, 421 U.S. at 672.”

 This is not limited to the processors, but to those who utilize contract manufacturers. From the FDA Law Blog – May 28, 2013 (reference below):

“The letters cite Park and Dotterweich to support the legal theory that a distributor that uses contract manufacturers or labelers may be liable (or convictable) for Current Good Manufacturing Practice ("CGMP") violations by its contractors.”

This is different than the PCA Peanut Butter cases, where officials knew they were shipping contaminated product. As seen in the Jensen case, it is more of a point that they should have known and taken preventive actions.


FDA Law Blog

February 06, 2011

FDA Finally Releases “Non-binding” Park Doctrine Criteria

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2011/02/fda-finally-releases-non-binding-park-doctrine-criteria.html

By Anne K. Walsh –

Eleven months after telling Senator Grassley (in a letter available here) that “[c]riteria now have been developed for consideration in selection of misdemeanor prosecution cases and will be incorporated into the revised policies and procedures that cover appropriate use of misdemeanor prosecutions,” FDA just last week finally released those criteria. The idea behind such criteria is to increase misdemeanor prosecutions against corporate officials under the Park doctrine. 

Jenson Brothers, Growers of Tainted Canteloupes, Arrested

The Jensen brothers, owners of the farm that grew and packed the Listeria tainted cantaloupes which were responsible for killing 33, have been arrested and now face jail time for the incident. This is in addition to having their farm go bankrupt, one owned by the family for generations. 

This case is a huge deal for all food operations in that owners/managers are facing prison for a foodborne outbreak. While all basically agree that there was no intent by the Jensen brothers, it is the fact that the shipped contaminated product from an operation with food safety lapses that have led to the misdemeanor charges, where intent is not a factor. The food safety lapses can be summed up”

1) They installed a potato washer to wash cantaloupes. It did not wash cantaloupes well, it did not cool them, and the equipment was not easy to clean. Because it was not easy to clean, it actually served as a source of contamination. By not cooling, the warmer temperatures provided better growing conditions for Listeria on the outside of the cantaloupe.

2) The chlorine sanitizer spray system was not operational.

The later point is worth noting. In certain applications, it is easy to overlook these microbial reduction interventions. Who knows, perhaps the location of the spray nozzles were located at a point where the chlorine would be quickly inactivated because of the solids on the cantaloupes, so they decided not to hook them up. 

It can be easy to look at a number of bacterial reduction interventions and wonder if there is a significant impact versus the cost of operating that intervention, or operating it at the level it should be operated. Or even maintaining the appropriate verification steps (checking concentration, conducing bacterial counts before and after) to ensure that the intervention is operating at that level it is supposed to be operating. 

So when the unfortunate event occurs, in this case one of the most deadly foodborne outbreaks in US history, investigators are going to look at everything - Is the process right for the products it is processing? Are the appropriate antimicrobial systems in place that are standard in the industry? Are the antimicrobials systems that are in place working, and are they operating at the right parameters? 

Companies need to use this case as a reason to review all processes, with specific attention to these antimicrobial interventions. If a system is in place, make sure it is working as it designed. If these systems are not operating, then either fix it. If they have been abandoned, then move it, replace it or remove it.

Note that these brothers are just farmers, one 37 years old, and the other 33. While the thought of jail time probably pales in comparison to the responsibility for 33 deaths, they probably wonder how some poor decisions led to where they are now.


United States Attorney’s Office – District of Colorado
New Release
http://www.justice.gov/usao/co/index.html

Eric and Ryan Jensen charged with introducing tainted cantaloupe into interstate commerceFOR IMMEDIATE RELEASE

September 26, 2013

DENVER – Eric Jensen, age 37, and Ryan Jensen, age 33, brothers who owned and operated Jensen Farms, located in Granada, Colorado, presented themselves to U.S. Marshals in Denver today, where taken into custody on federal charges brought by the U.S. Attorney’s Office with the Food and Drug Administration – Office of Criminal Investigation, United States Attorney John Walsh and Food and Drug Administration (FDA) Office of Criminal Investigations Special Agent in Charge Patrick Holland announced. The Information charges the brothers with introducing adulterated food into interstate commerce. The defendants are scheduled to make their initial appearance this afternoon at 2:00 p.m. before U.S. Magistrate Judge Michael E. Hegarty. At that hearing they will be advised of their rights as well as the charges pending against them.

According to the six-count Information filed under restriction on September 24, 2013, as well as other court records, Eric and Ryan Jensen allegedly introduced adulterated cantaloupe into interstate commerce. Specifically, the cantaloupe bore a poisonous bacteria, Listeria monocytogenes. The Information further states that the cantaloupe was prepared, packed and held under conditions which rendered it injurious to health.

Salad Items Recalled due to Potenial Listeria Contamination

Update 10/25/13 - Garden Fresh is expanding its recall http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2013/recall-055-2013-expansion

Garden Fresh Foods of Wisconsin is recalling various salad, slaw and dip items due to the potential for Listeria monocytogenes. The problem was discovered through product testing conducted by FDA.  To date, there have not been any reported illnesses.

Product was shipped nationally under various brand names: Market Pantry, Archer Farms (both Target brands), D’Amico and Sons, Finest Traditions, Garden Fresh and Weis.

This same company issued a recall back at the beginning of the month. This was a smaller recall, that for potato salad, but for the same reason – the potential for Listeria as well (link below). That was discovered through routine sampling. Being that occurred over three weeks ago, it would probably indicate the company was under increased scrutiny. And this may be why the latest recall notice indicated that the pathogen was discovered through testing done by FDA.

As we discuss many times, this is a reason for companies using co-packing operations to watch recall notices and consider strong action when their co-packer has an issue. It may not be your brand initially impacted or even the product you purchase, but in too many cases, we see these contamination events rapidly expand when FDA or USDA investigate smaller issues and find the troubled manufacturer has bigger issues that impact a broader set of products.


USDA Recall Alert
Wisconsin Firm Recalls Ready-To-Eat Chicken And Ham Products Due To Potential Listeria Monocytogenes Contamination
Class I Recall 055-2013

Health Risk: High Sep 25, 2013

Congressional and Public Affairs
Catherine Cochran
(202) 720-9113

WASHINGTON, Sept. 25, 2013 – Garden Fresh Foods, a Milwaukee, Wisc.establishment, is recalling approximately 19,054 pounds of ready-to-eat chicken and ham products due to possible contamination with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Overstating the Link of Antibiotic Resitant Bacteria in Animals to Humans

There has been a huge concern on the importance of antibiotic resistant strains of Salmonella in domestic animals and their impact on humans.  In a comprehensive study conducted over a 22 year period that evaluated DNA variation, researchers have found that there is little cross-over from animals to humans and therefore domestic animals are unlikely to be a major source of antibiotic resistant Salmonella strains in humans.

“The team discovered that, contrary to much current thinking, the populations of Salmonella in humans and animals were distinguishable. They also found that the estimated number of times that the bacteria had jumped from animals to humans (and vice versa) was remarkably low. In addition, there was greater diversity in antibiotic resistance genes in salmonellae isolated from humans. Taken together, these findings suggest that the contribution of local animal populations to human infections with S. Typhimurium DT104 may previously have been overstated.”

The author of the study goes on to say “"This finding in no way undermines the importance of prudent antimicrobial use in all species. But our study does demonstrate that greater effort needs to be focused on understanding the natural history of the pathogens and on identifying the major sources of resistance in our global ecosystems."

With regard to our inability to completely comprehend why and where bacteria do what they do, Dr. Steve Goodfellow, a seasoned food microbiologist, liked to say that ‘bacteria don’t read the textbooks’.   I think we can also say that bacteria don’t follow stories put out by the news media either.

 

Contribution of Local Animal Populations to Human Salmonella Infections Overstated

Science Daily
http://www.sciencedaily.com/releases/2013/09/130912143421.htm

Sep. 12, 2013 — A new study has shown that, contrary to popular belief, local domestic animals are unlikely to be the major source of antibiotic resistant Salmonella in humans. The result comes from a detailed study of DNA from more than 370 Salmonella samples collected over a 22-year period.

By studying the genetic variation in the Salmonella bacteria and their drug resistance genes, researchers found that distinguishable bacterial populations exist in human and animal populations living side by side. Antibiotic resistance is considered to be one of the most important dangers to human health, threatening to make many treatments to common infections ineffective. By comparing the genomes of Salmonella in humans and animals the researchers have provided important new insights into the likely sources and spread of antibiotic resistant infections. First, the Salmonella bacteria largely remained within their original host populations and second, there were more varied combinations of drug resistance in the human-infecting bacteria.

Salmonella infection is a global issue, with approximately 94 million people contracting gastroenteritis or food poisoning each year. The combined annual cost in the United States and European Union is estimated to be more than £4 billion ($6 billion). This public health issue is exacerbated further by antibiotic resistance, which can lead to more complicated and protracted illness in patients and increased treatment costs.

"For the first time we've determined in detail and on a large scale how Salmonella strains taken from humans and animals in the same setting and over the same time period relate to each other," says Dr Alison Mather, first author on the study, from the Wellcome Trust Sanger Institute. "Our genomic data reveal how the Salmonella bacteria spread during the course of a long-term epidemic. We found that people have a more diverse source of infection and antibiotic resistance than just the local animals, pointing towards alternative sources."

The team sequenced DNA from 373 samples from humans and animals infected with Salmonella Typhimurium DT104 over a 22-year period, mainly from Scotland, but also from other countries. This is the largest study of its type; whole genome DNA sequencing delivers the highest level of resolution possible to examine how closely related the bacteria are, enabling the team to unravel the details of this epidemic.

The team discovered that, contrary to much current thinking, the populations of Salmonella in humans and animals were distinguishable. They also found that the estimated number of times that the bacteria had jumped from animals to humans (and vice versa) was remarkably low. In addition, there was greater diversity in antibiotic resistance genes in salmonellae isolated from humans. Taken together, these findings suggest that the contribution of local animal populations to human infections with S. Typhimurium DT104 may previously have been overstated.

Chobani Recalls Greek Yogurt Due to Quality Issues

Chobani is recalling its Greek Yogurt due to issues encountered by consumers, namely product bloating / swelling. News reports suggest the issue may be related to mold and that there may be some related illnesses.

Initially the company cited this as a quality issue and did not recall the product. But after public outcry and a solid media beat-down, the company issued a recall and ceased distribution of the product (Guardian article below).

Chobani pioneered Greek yogurt, and now controls 35% of the Greek yogurt market. And this market has taken a serious bite out of the traditional yogurt markets, now accounting for about 1/3 of the US yogurt market. Much of this is due to the products higher protein content compared to traditional yogurt (see the nice NY Times article below).

This issue and the lack of a firm response will certainly give the competitors a leg up. Especially when this company had such a ‘consumer oriented’ brand. We’ll need to watch how market share changes after this incident. This case is one of those hard lessons all food companies can learn from.


FDA News Release
Chobani, Inc. Voluntarily Recalls Greek Yogurt Because of Product Concerns
FOR IMMEDIATE RELEASE - September 5, 2013 - Chobani, Inc., of Twin Falls, Idaho is voluntarily recalling Greek Yogurt.
http://www.fda.gov/Safety/Recalls/ucm367298.htm

The company has ceased the distribution of the product due to reports of product bloating and swelling and some claims of illness as the company continues its investigation to identify the root cause.

Let the Alarmism Begin on The Safety of Spices

Earlier this week, we commented on the New York Times report regarding an FDA study on the safety of spices (http://pennstatefoodsafety.blogspot.com/2013/08/safety-of-imported-foods-spices-and-fsma.html) . We indicated that there is essentially no risk for consumers when buying spices from the grocery store. Brand label spices are produced by reputable companies, such as McCormick, have extensive food safety systems in place that minimize the risk.

But unfortunately, major media outlets can’t help themselves from jumping on this study and spreading some fear. At least, the NY Times article’s title ‘Spices’ Link to Food Ills Prompts Changes in Farming’ wasn’t overly misleading. But from that article, other news outlets had their own spin in order to ‘one-up’ the other. Let’s take a look at these titles. 

From NPR, we have ‘ Your Kitchen Spices Can Often Harbor Salmonella’. The title suggests something that is completely inaccurate. Even the reader’s comments at the bottom of the article (you can connect to the link on the article below to read) indicate that these readers know that this is over-the-top fear mongering.

NPR is not the only one. LA Weekly has an article “Spices a Potent Source of Food Poisoning”. Not to be outdone MSN News has - Rumor: Common kitchen spices contain salmonella’ and goes on to state that this rumor is true. No it is not.

Certainly there have been a few incidents that contaminated spices have resulted in illnesses, but these were extremely isolated and due to unique circumstances. Going back to look at the original study, there are few things we can see in this FDA study which was published in Food Microbiology that warrant comment :

• The sampling in the study primarily evaluated untreated spices which had a higher level of contamination…as we would expect. Will those spices be treated at some point during further processing….probably yes?
• We don’t know the type of importer for the spices that were found positive. Were the major spice companies, or smaller importers? Companies with familiar brands names must protect those brands, and thus will have solid quality and safety programs including preventive control measures. But unfortunately, this study does not indicate they type of company. And the news articles then lump all spice companies together.

This is not to say that these companies representing major brands will not have the occasional issue, but they are few and far between. So as I put pepper on my pizza tonight, I will not worry about Salmonella contamination. Will you worry about the spices in your cabinet? Probably not.

The real take home from the FDA study is that companies who import spices need to have preventive controls in place to ensure the safety of those items.



Your Kitchen Spices Can Often Harbor Salmonella
by Nancy Shute
August 29, 2013 3:16 PM
NPR – The Salt
http://www.npr.org/blogs/thesalt/2013/08/28/216550862/your-kitchen-spices-can-often-harbor-salmonella

 Spice may be nice, but spices also can carry very bad bugs. About 7 percent of spices tested by Food and Drug Administration researchers were contaminated with salmonella, which can cause serious illness and death. Because of this finding and others, the FDA and international food safety organizations are putting more effort into how to reduce the risk.

 

A New York Times

article this week really brought the issue to everyone's attention. Here are some of the questions we've been asking about spices and salmonella here at The Salt:

Safety of Imported Foods - Spices and FSMA

A NY Times article released today (below with link) details the high contamination Salmonella rate of spices and the challenges that exist in importing products. Primarily, these spices are produced in tropical zones in ‘rustic’ conditions. Because of this, these items have a high risk of becoming contaminated with Salmonella (from birds, animal manure, reptiles, etc) and then, that organism can survive in these dried spices for months or longer.

Spices have been processed this way it has been since the time of the spice trade, thousands of years ago. But as consumers, do we generally worry about the safety of spices? Generally not. Companies that have been involved in buying and selling spices have secured their supply chains and where needed, have added interventions such as irradiation to eliminate these bacterial hazards. So there is no risk to the consumer, when you look at the vast quantities of spice consumed each day in this country.

This is not to say there have not been issues, but primarily those issues were linked to food companies using less than reliable sources for their spices. In the small number of cases where there have been issues, importers of spice did not have adequate control measures in place.

So what is the point of the NY Times article? It is directed at the Foreign Supplier Verification Program (FSVP) component of FSMA. In this proposed regulation, emphasis is put on the companies who import food to ensure the safety of those foods. It defines the importer as the person in the US who has purchased the item, and in many cases, this can be the retailer or the distributor. 

The NY Times piece provides ammunition for those who feel that the federal government should have a heavier hand in determining the safety of those imported food items. This would necessitate a heavy testing program conducted by the government agencies at the border for incoming foods and having FDA inspectors inspect foreign companies.

With about 15% of the food consumed in this country being imported, it is not financially feasible to have FDA take on that responsibility. The concept proposed in FSVP is better…making companies responsible for the foods they import. We just have to look at companies like McCormick who have practiced the safe importation and processing of spices for more than a century.  

For those identified as importers, FSVP provides the elements of a supplier verification program that these companies will need to establish for each suppler, including verifying that he supplier has a HACCP type system in place and conducting verification, corrective action, and record keeping activities.

In the long run, FSVP will create a stronger food supply system. Companies who sell imported foods will either be forced out of selling if they are not willing or capable of implementing such an adequate supplier contol system, or will need to align with an importer who does have the necessary capabilities.


NY Times
Spices’ Link to Food Ills Prompts Changes in Farming
By GARDINER HARRIS
Published: August 27, 2013
http://www.nytimes.com/2013/08/28/world/asia/farmers-change-over-spices-link-to-food-ills.html?pagewanted=1&_r=0

IDUKKI, India — Spices grown in the mist-shrouded Western Ghats here have fueled wars, fortunes and even the discovery of continents, and for thousands of years farmers harvested them in the same traditional ways. Until now.

Science has revealed what ancient kings and sultans never knew: instead of improving health, spices sometimes make people very sick, so Indian government officials are quietly pushing some of the most far-reaching changes ever in the way farmers here pick, dry and thresh their rich bounty.

The United States Food and Drug Administration will soon release a comprehensive analysis that pinpoints imported spices, found in just about every kitchen in the Western world, as a surprisingly potent source of salmonella poisoning.

Cyclospora cases now over 600, Texas cases not linked to Taylor bagged salad

As of August 26th, CDC is reporting that there are 610 cases of Cyclospora infection in 22 states. While many of the illnesses in IA and NB were linked to bagged salad mix produced by Taylor Farms de Mexico, CDC indicates that a number of cases in Texas are unrelated to the cases in IA and NB, but rather originated with people eating at the same restaurant..

CDC is investigating the Texas cases as well as the cases seen in other states to see how any of them might be related and what might be the source (CDC release below).

The Taylor Farms facility in Mexico that was linked to the IA and NB cases has resumed production after undergoing an extensive FDA audit. (story and link below).


CDC News
Investigation of an Outbreak of Cyclosporiasis in the United Stateshttp://www.cdc.gov/parasites/cyclosporiasis/outbreaks/investigation-2013.html

LAST UPDATED AUGUST 26, 2013 7:00 PM EDT
Case counts are updated Mondays, Wednesdays, and Fridays
On June 28, 2013, CDC was notified of 2 laboratory-confirmed cases of Cyclospora infection in Iowa residents who had become ill in June and did not have a history of international travel during the 14 days before the onset of illness. Since that date, CDC has been collaborating with public health officials in multiple states and the U.S. Food and Drug Administration (FDA) to investigate an outbreak of cyclosporiasis.

Highlights
Read the Advice to Consumers
Read the Guidance for Laboratories
Cyclospora cayetanensis is a single-celled parasite that causes an intestinal infection called cyclosporiasis.
As of August 23, 2013 (5pm EDT), CDC has been notified of 610 ill persons with Cyclospora infection from 22 states: Arkansas, California, Connecticut, Florida, Georgia, Illinois, Iowa, Kansas, Louisiana, Minnesota, Missouri, Nebraska, New Jersey, New Hampshire, New York (including New York City), Ohio, South Dakota, Tennessee, Texas, Virginia, Wisconsin, and Wyoming.
Most of the illness onset dates have ranged from mid-June through mid-July.
Among 581 ill persons with available information, 43 (7%) have reported being hospitalized. No deaths have been reported.
Public health officials in Iowa and Nebraska performed investigations within their states and concluded that restaurant-associated cases of Cyclospora infection in their states were linked to a salad mix produced by Taylor Farms de Mexico.
On August 12, 2013, Taylor Farms de Mexico informed FDA that the company had voluntarily suspended production and shipment of any salad mix, leafy green, or salad mix components from its operations in Mexico to the United States.
On August 25, 2013, Taylor Farms de Mexico, with FDA concurrence , resumed production and shipment of salad mix, leafy greens, and salad mix components to the United States.
Currently, CDC is collaborating with the Texas Department of Health and Human Services and local public health departments to investigate cases of cyclosporiasis reported among people in Texas.
The preliminary analysis of results from an investigation into a cluster of cases that ate at a Texas restaurant does not show a connection to Taylor Farms de Mexico. This investigation is ongoing.
Although the investigation of cases continues, available evidence suggests that not all of the cases of cyclosporiasis in the various states are directly related to each other.

What is Gluten Free - FDA sets a standard

FDA established a standard that defines “Gluten Free”. Gluten free is a food that does not contain an a gluten containing grain such as wheat, does not contain an ingredient that is derived from a gluten containing grain, and does not contain an ingredient derived from a gluten containing grain that has been processed to remove the protein (such as wheat starch) where that ingredient has more than 20 ppm of gluten. And is produced so that the food will not be contaminated with the unavoidable presence of gluten to a level of no more than 20 ppm.

Foods that are free of gluten by their nature can be labeled as gluten free, however they do not have to be labeled as such if they are gluten free. It is voluntary. Manufacturers are not required to test for the presence of gluten, but are required to meet the requirements of the law, so manufacturers can use a number of tools to meet the standard.

Establishing this set standard allows uniform labeling thus making it easier for those with the celiac disease to make informed decisions regarding food items.

Gluten is protein that is found in wheat, rye, barley. In people with celiac disease, gluten triggers an immune reaction that results in antibodies attacking the intestinal lining. It can be painful for those individuals who inadvertently ingest gluten. It can also impact absorption of nutrients from the intestines. This condition is especially problematic in children where it can lead to growth problems, and weight loss. For adults, in addition to the stomach issues, it can lead to long term effects such as malnutrition, liver disease, and cancer of the intestines. It is estimated that roughly 1 in 100 people have the disease (whether they know it or not). http://www.celiac.com/articles/23024/1/Just-How-Common-are-Celiac-Disease-and-Gluten-Sensitivity/Page1.html

It is important to remember that gluten is an important part of the diet and a gluten free diet is not recommended for the general public



FDA NEWS RELEASE
 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm363474.htm
For Immediate Release: August 2, 2013

Media Inquiries: Shelly Burgess 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
En Español1

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 today in the Federal Register2.

For more information:
FDA: Gluten-Free Labeling3
FDA: Gluten-Free Labeling Final Rule Q&A4
Consumer Update5 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.