My first exposure to Celiac Disease was several years ago when we were working on ingredient label regulations and we got so many comments from patients and families of Celiac Disease persons that we really had to go and research the disease, find out more about it, and see how we could, as time moved on, assist these consumers in avoiding gluten containing products.
Just to give you an overview of where FDA gets its guidance, how we establish regulations, we must go back to the Food, Drug and Cosmetic Act. It is this act that was written by Congress initially in 1938, that gave FDA ( At that time FDA was a part of USDA) the authority to insure that the food supply was safe, and that any information on food labels was truthful and not misleading. So from 1938 until 1950, FDA worked and operated under the Food, Drug, and Cosmetic Act.
It also seems that during that span of time, a descriptive array of terms such as Light and Low Cholesterol began to appear on labels. Sometimes these terms were used haphazardly, and also questionable health claims began to appear on food labels, stating that they could prevent certain types of diseases, or in fact, lower the risk of certain diet related diseases. In some cases ingredients were not always labeled properly, and last but not least, nutrition labeling was optional. Secretary Sullivan, at that time, said that what had happened to the food label left consumers dealing with a Tower of Babel.
Regulatory agencies in the United States that govern the food industry and the food market are those that you see listed here. FDA, I have at the top of the list. I may be somewhat biased by that! We do really regulate about 98% of all of the food products that are available for you as consumers. And as I said, that is done under the Federal Food, Drug, and Cosmetic Act. We regulate seafood and game meat. However, meat and poultry products are regulated by USDA. Now this often presents confusion for consumers, because they aren't aware that there is this line of demarkation between the two agencies. What we try to do with USDA is maintain consistent regulations so that information that is provided on products regulated by FDA are also provided by on products regulated by USDA. The situation gets even more complicated because while USDA is responsible for the grading and safe production of meat and labeling of meat and poultry, FDA is responsible for what drugs may be used in cows and chickens, etc. And while, FDA is responsible for the labeling of commodities, USDA is responsible for growing commodities, pesticide use, etc.
Also, the Bureau of Alcohol, Tobacco and Firearms regulates alcohol. We have gotten requests and comments in the past from Celiac patients asking about types of alcohol that they could safely consume. Because we don't regulate this product, we aren't able to direct questions or answers regarding the types of alcohol that would be permitted in your diet. So I inform you that for more information regarding those types of products, you would need to contact the Bureau of Alcohol, Tobacco and Firearms. Now, again, there is a line of demarkation. Alcohol and beverages that contain 7% or more alcohol are regulated by BATF. Less than that would come under FDA perview, such as your wine coolers.
And finally, the Federal Trade Commission is responsible to insure that all information that appears in advertising, commercials, magazines, newspaper articles, is in fact truthful and not misleading. Again, getting back to the Federal Food, Drug and Cosmetic Act, and the situation that food labeling had reached by the mid 1980's, Congress decided that it was time to amend the Food, Drug and Cosmetic Act, to update it. And they passed legislation and the President signed into law on November 8th of 1990, The Nutrition Labeling and Education Act. Now this act was far reaching. There were several objectives of this act, which we refer to as the 1990 Amendments. The objectives were to clear up consumers' confusion about food labels, to aid consumers in making health food choices, and to encourage product innovation by giving manufacturers an incentive to improve the quality of the food and make more healthy food choices available.
The FDA was given one year to propose regulations to implement the Nutrition, Labeling and Education Act. And the staff at the Center for Food Safety and Applied Nutrition, whether willingly or grudgingly, took the task to do this. Meeting the Congressional mandate of one year, we published over 2500 pages of proposed regulations. The regulations were far reaching. We dealt with nutrition labeling. We dealt with nutrient content claims. We dealt with health claims, and what I think is most important and most desirous of information by this group is the ingredient labeling provisions. While the Nutrition, Labeling and Education Act did update some of the ingredient label provisions, the majority of the ingredient label provisions that are in force currently are those that have been in force since the Act of 1938. There are some regulations that have been established during that interim in response to specific health needs, food allergies, and I will touch on a few of those as we go through the presentation.
But generally, food labeling ingredient provisions are that basically, any food that is fabricated from two or more ingredients must declare each of its ingredients in the ingredient list. This provision is quoted directly from the Food, Drug, and Cosmetic Act. And it states that it must be by common and usual name. Now in some cases, the Agency has established what a common and usual name should be. We have done that through the Standards of Identity, which are specific recipes that manufacturers have to follow in making certain foods, such as bread, such as mayonnaise, margarine. These foods have to be made according to a standard. Other cases in which we have specific common usual names are where the Agency has established regulations governing food additives. In many cases the Agency is petitioned by members of industry to add a particular ingredient to the list of safe and suitable ingredients that can be used in the US food supply.
The other thing I would like to just point out here, is that any food that is sold to US consumers must meet the FDA guidelines, irregardless of whether the food is domestically prepared or imported. It sometimes becomes difficult, however, to verify that imported foods are made according to US standards. But the Federal Food, Drug and Cosmetic Act does not differentiate between imported or domestic foods. It just states that we are required to govern food sold to US consumers.
Also, included in the Act, as a part of the 1990 Amendments, is that standardized foods must now declare each of their ingredients. Because these standardized foods are prepared according to a recipe, it had been tradition in the industry, and I must say the FDA did not rigorously enforce otherwise, that many of these foods would not declare specific ingredients. For instance, you may see bread listed on a deli sandwich, but it would not have the type of flour, the enrichment nutrients, if there were any, salt, other seasonings that had been added to prepare that bread. Congress felt that this was inappropriate and therefore amended this requirement in the Act, so now all standardized foods must declare their ingredients.
Finally, also included as part of the 1990 Amendments, was that color additives that are required to be certified must be declared by common and usual name. The Act itself provides an exemption for flavorings, colorings and spices. These ingredients, when added to other foods, do not have to be declared by the specific name of the ingredient, but can be declared collectively. Congress felt that this also was inappropriate because certified colors are batch certified; they must be approved by FDA before they can be used in products. It was felt that these ingredients should be declared by their common and usual name. Now what we have done in the past to encourage manufacturers to do this while we didn't have the right to require it, was to permit them to use abbreviated terms, like Blue 1 and Blue 1 Lake. So any certified color that is now used in a product should be declared by its common and usual name. I know that really does not get at the questions that were raised about non-certified colors like annato and beta carotene. The Act, again, does not provide FDA the authority to require specific declarations of those ingredients. In order for FDA to be able to have that type of requirement, it would be necessary to change our governing Act through Congress, in the same manner that the NLEA has updated the provisions of the Act.
One of the provisions that was a part of our new labeling regulation, although not specifically required by the 1990 Amendments, was that source declaration is now required for protein hydrolysis. I think this is one measure where the FDA has moved forward, and it is a provision that will assist Celiac patients in avoiding gluten containing products. In the past, protein hydrolysis could have been labeled as a vegetable protein hydrolysis or an animal protein hydrolysis, which gave you no indication of which vegetable it may have come from. In addition, protein hydrolyses that were used for flavoring of food, could be - I should not say could be - manufacturers were declaring these products under terms like artificial flavor or flavor added. When FDA reviewed the situation, we determined that protein hydrolysis, whether used for flavoring or not, always functioned as flavor enhancers. Flavor enhancers are not exempt by the act from ingredient declaration. As a result of this, any protein hydrolysis that is used in a product, must be declared by its common and usual name, and that common and usual name must include the source. So declarations that at one time said hydrolyzed vegetable protein would now say hydrolyzed wheat protein, hydrolyzed soy protein, hydrolyzed corn and soy protein if both had been used. This is - as I hope you will agree - an improvement over listing this ingredient in the past.
Also, the declaration of non-dairy on some products is required by some state legislation. The FDA felt that this was misleading for consumers who were attempting to avoid dairy products, not realizing that sodium caseinate is a milk derived ingredient and is permitted in products labeled non-dairy. So this was an additional provision included upon FDA's own decision that the labeling without this type of information in the ingredient list was misleading.
Another issue that seemed to be generating concern among Celiac patients was that governing wheat and resin coatings on fresh produce. As I stated, the Food, Drug and Cosmetic Act states that any fabricated food of two or more ingredients must declare each ingredient. The agency's policy had been that fruits and vegetables that were coated with wax and resin coating were in fact a fabricated food, and these foods should declare what wax or resin coating had been applied. While on a practical matter, industry was unable to adhere to this particular requirement, especially at the retail level. We were told that the coatings may change based on the season, based on the commodity, based on where the commodity is grown, and where the commodity is sold. So, in an effort to assist industry and meeting the requirement of the Act, we provided two categories that can be used to declare wax and resin coating on fresh produce. Now this is done at the retail level. We provided flexibility, however, for retail establishments to determine the number and types of signs that would be required to insure that consumers get this information. Basically, the concern at that time, as we had been informed, was that consumers wanted to know if animal based products had been used on fruits and vegetables. Hence, the two categories reflect either the use of an animal based product or the non-use of an animal based product.
About a year and a half ago, I began to get a series of letters raising concern that the FDA was about to approve a wheat based coating for fresh fruits and vegetables. After the first letter, I wasn't quite sure where the information had come from. But when I got 30, 40, and ultimately about 200 letters, it really concerned us, because FDA had not previously, nor were we currently reviewing any type of petition request for wheat based coating. We had contacted industry; it was also a mystery to industry. They were not using these types of coatings on products. Finally, I was able to trace the source, and I think it was an attempt to head off FDA approving this type of ingredient for fresh fruits and produce. Let me assure you that as of today, there is not any type of request or petition before the agency to include a wheat based coating for fresh fruits and vegetables. If there ever becomes a wheat based coating for commercial use, the agency would then review what conditions are necessary to insure that the product is used safely and would not be a concern for Celiac patients. We recognize that fruits and vegetables are one of the food types that you can eat without concern.
Spices, flavorings and colorings, again as I've stated, are precluded from the Act from being specifically declared in the ingredient statement unless the product is sold as such. Again, for FDA to mandate specific ingredients in these products, it would require a change in the Food, Drug, and Cosmetic Act.
As I'm sure you're all aware, as with any regulations, there is going to be exemptions. And this is probably the area that causes the Celiac patient the most concerns. And that is the area of incidental additives. Basically, for a product to be considered an incidental additive, it has to be present in the finished food at an insignificant level. Now "insignificant" can be a very nebulous term. The FDA has not set threshold levels of what we consider to be insignificant. It may depend on the ingredient, it would depend on the function of the ingredient, it will depend on how that ingredient is used in the food or how it was used when processing. But what we have said is that for a manufacturer to determine that there is an ingredient that can be exempt from ingredient labeling, it must meet certain tests. It must be present at insignificant levels; it must not have any technical or functional effect in the finished food. Now there are several ways in which these ingredients could be incorporated. They could be added as an ingredient to another food. Now in this case, the labeling gets somewhat complicated, because we have alternative mechanisms for which a manufacturer may label a product. If you have a multi-ingredient food, for instance, bread, that would be declared in an ingredient statement -- let's say you have a bread pudding, and the manufacturer declares bread. He would then be required to parenthetically declare the type of flour, the enrichment nutrients if any were used, and any other ingredients that were added to make this bread. But he also has the alternative of not using the term "bread" and using just the ingredients that made up the bread, declaring those ingredients independently in descending order predominance in the ingredient list. If he takes this particular alternative, some of those ingredients become incidental additives to the finished food, and may not need to be declared in the ingredient label.
Processing aids are another area that the agency has established exemptions for specific ingredient labeling. If a substance is added and then completely removed during the processing, that ingredient is not required to be declared in ingredient labeling. Again, with each of these, the three requirements must first be met: no technical or functional effect in the finished food, and present in insignificant levels. Also, substances that are added and converted into constituents normally present in the food would not need to be declared in ingredient labeling, provided that the addition of the constituent does not increase the amount over the amount that would normally be in that product. And as I stated, substances with no added technical or functional effect.
An area that I know, based on comments that I have received, is of concern to the Celiac patient, is ingredients that are used in equipment and packaging. You may have a wheat based flour that coats a belt making corn tortilla chips, where there may be some gluten that is incorporated into the product. The way our regulations have been designed, and by the way, these are exemptions that have been in place for many, many years. If the substance migrating from the equipment or packaging meets the test "present in insignificant levels", and "no technical or functional effect in the finished food", it is not required to be declared in ingredient labeling.
Now just to give you a bit of background as to how FDA and why FDA established these exemptions, one of the bases in the Act states that FDA cannot place requirements on manufacturers that would be impractical. The information that the Agency was provided with in establishing these exemptions from labeling was that Number 1, many of these ingredients are not consistently used from one batch to another. Sometimes it's based on availability. That the purpose of using these ingredients really has nothing to do with the finished food, is not a meaningful part of the finished food, and to declare each of these ingredients, you would have an unusable and lengthy ingredient label.
Those were the primary motivations behind FDA establishing these types of exemptions. Recognized, however, that although these exemptions are still in place, FDA has required specific labeling of certain ingredients when scientific evidence has been presented to us indicating that consumers need to be aware that this ingredient is in the food. Examples of this would be sulfiting agents. Several years ago, the Agency was presented with evidence that consumers who were allergic to sulfiting agents were getting ill, and in some cases the illnesses became fatal, because some consumers died from ingestion of sulfites. While sulfites, in most cases are used as, or could meet the test of being an incidental additive, the Agency did not feel it was appropriate not to have these substances declared in ingredient labeling. Therefore, a special regulation or provision was established to require that when sulfiting agents were present in a food, at 10 part per million or greater - and at that time that was a detectable level - that the inclusion of this ingredient had to be declared in ingredient labeling.
Another instance that the Agency has required specific declaration was in the case of Yellow # 5. Prior to the 1990 Amendments, as I've stated, coloring agents could just be declared as color added. However, even at that time, Yellow # 5 had been shown to cause fatalities and serious illness. So whenever Yellow # 5 was contained in a product, it had to be declared by its common and usual name.
I give you this information, because even though we have these exemptions in place, there is still a mechanism provided by the Act that the Agency insure that the food supply is safe, where we can require declaration of specific ingredients, as I said, when presented with information that it is necessary to insure safe use of the ingredient.
I also wanted to touch on a few specific regulations regarding ingredients that I have been questioned about over the past year and a half or so. Corn Starch: corn starch is a food additive that is regulated by FDA. We have a specific regulation that defines how corn starch is to be made, what specifications it is to meet, and how it is to be declared in the ingredient statement. We also have what is called compliance policy guides. Now, while our compliance policy guides to not have the same force as our regulations - the same force of law as our regulations - compliance policy guides have been held up in court when we have charged manufacturers with violating this policy. The compliance policy guide that deals with declaration of starch states that, starch declared in the ingredient statement, unqualified, means corn starch. Now I don't want to alarm any of you - that is not to say that there aren't manufacturers out there who are not complying with our regulations or our policy. That is always a possibility regardless of what the regulation or policy is. The way that we are able to fine these manufacturers, more often than not, is through consumer complaints, trade complaints. We just do not have the resources to monitor each and every food manufacturer to insure that he is following our guidelines. But these are guidelines and policies that we have in place. We also say in this compliance policy guide that if corn is not the source of the starch, the declaration should include the source: tapioca starch, wheat starch, etc.
Modified food starch was another ingredient that I have been questioned about. Again, we have a food additive regulation that states how modified food starch is to be made. In this particular case, we do not specify that the only source starch can be corn. Part of the issue here, however, has dealt with additional information that was submitted to the Agency following our proposals in 1991. Based on what the industry provided as well as literature searches, indicated that in the preparation of a modified food starch, the starch is isolated from the protein component of the source food. While there is no absolute in any form of science, the information indicates that the possibility of having protein components included in a modified food starch are rare. In addition to that, the type of information that the Agency would need to amend or revise our regulations regarding declaration of ingredients would be information that says, "the ingredient that's currently used and currently labeled becomes a potential health hazard." If we had information to indicate that modified food starch used the way it is traditionally used in foods caused consumers with Celiac Disease or any other type of food intolerance or food allergy, caused them health problems, we would have to reevaluate the appropriate manner in which this ingredient should be used and declared. And I say this because it is important that as the medical community receives this information, as research is done, as the science supports, the information needs to be submitted to us, so that we can have this while we are reviewing these issues. If we don't have the information, we may not be aware that there has been incidence of problems from ingestion of these various ingredients in the manner in which they have been used in the food.
Vinegar is another ingredient that seems to raise concern among the Celiac patient. Again, we do not have regulations that govern vinegar, but we do have compliance policy guides, again, that have been in effect for several years. In our compliance policy guide on vinegar we state eight different types of vinegar, and I'll briefly go through those, and their declarations. If a vinegar is declared as vinegar, cider vinegar, or apple vinegar the compliance policy guide states the product is made by the alcoholic and subsequent acetious fermentations of the juice of apples. If it's wine vinegar or grape vinegar, it is made from the juice of grapes. Malt vinegar is made from starch that has been converted by malt. Sugar vinegar - made from sugar syrup, molasses or refiner's syrup. Glucose vinegar - from glucose. Spirit vinegar, distilled vinegar, or grain vinegar - now, this is a vinegar that may present problems; it is made from distilled alcohol. Vinegar made from a mixture of spirit vinegar and cider vinegar would be as described for cider and spirit, and then vinegar made from dried apples, apple cores and apple peels.
In addition, FDA has regulations specifically governing ingredients corn gluten and wheat gluten. These are food additive regulations; there are specifications for which manufacturers must adhere in making these ingredients. And if these ingredients are added to a product, must be declared by the term corn gluten or wheat gluten.
And barley malt - again, the term malt or malt extract - again, we have a regulation, a generally recognized as safe regulation for malt syrup, malt extract. And for an ingredient to carry the term, or to be declared by the term malt syrup or malt extract, it must be prepared in accordance with the regulation, and the regulation states that is a product of barley. Now, while we do not have a compliance policy guide similar to that we have for starch, the Agency would consider any type of malt that is made from a source other than barley, for it to be adequately and sufficiently described in the ingredient statement, it would need to include the source from which it was made. Often times, however, manufacturers may not seek the FDA to determine what the correct policy would be in labeling the product, and they may use these terms without having asked the FDA what would be the appropriate manner in which they should be declared. But malt, unqualified, does mean barley malt in an ingredient statement as far as FDA guidelines are concerned.
During the comment period, in response to the 1991 proposals, we got several requests that the Agency establish guidelines and regulations for gluten-free foods. At the time of our final regulation, we responded to this comment by saying that without information including analytical methodology of how gluten-free could be verified, we were unable to establish such regulations. However, when there are products that are labeled as gluten-free, the Agency requests that manufacturers adhere to the policy on hypoallergenic foods. While the Agency recognizes that Celiac Disease is a food intolerance and not an allergy, our regulations regarding hypoallergenic foods are very specific in that any ingredient, incidental additive, ingredient that may be on packaging or equipment, cannot be used in a product, if that product is being manufactured, marketed and sold as a food for persons with specific allergies. Therefore, if there are products on the market that are labeling the products as gluten-free, those products should be made in accordance with our guidelines on hypoallergenic foods.
While FDA has not established requirements specific to the labeling or marketing production of gluten-free foods, the Codex Alimentarious Commission, which is a joint body of the Food Agricultural Organization and the World Health Organization, has recently been looking at what requirements would be necessary for developing guidelines and standards for gluten-free foods. At the most recent meeting of the Codex Committee on Nutrition and Foods for Special Dietary Use, gluten-free foods was an agenda item. However, there was much controversy and discussion at this particular meeting, and the committee was not able to move forward with developing standards for gluten-free foods. Some of the questions that arose - and I present them to you here also - While FDA has not moved forward with developing regulations for gluten-free labeling, we are very much involved with the Codex process. Some of the questions that will be answered through the Codex process are the same types of questions that FDA would have to answer, if it were to promulgate rule making specific for gluten-free foods.
Although I was not at this meeting, colleagues of mine stated that there was some disagreement in the medical community as to whether there was a threshold amount of gluten that could be consumed by Celiac patients. There are some that say that absolutely no gluten is tolerable. There have been others that have stated that very minute amounts of gluten may be tolerable. The Codex is an international organization, and they set world standards, so you have various countries that are working together to establish these. And while the U.S. may have one position based on scientists and evidence it has received, other countries based on evidence that their scientists have provided them, may not be in total agreement. And until there is agreement among these countries that make up the Codex Alimentary Commission, it is difficult to move standards forward.
What I have also been informed of, is that members of the U.S. delegation for the Committee on Nutrition and Foods for Special Dietary Uses - they're planning to submit and get comments back from persons in the U.S. medical community. As I understand it, they will be sending out minutes from this meeting to various medical organizations for distribution among their members to comment and return back to us. These are the questions that we need to have answered to fully understand what would be required for gluten-free food. Is there a threshold level? If there is or isn't, what is the scientific evidence to support that position? What type of analytical methodology needs to be in place so we can verify that label statements are true. This is very important because one of the charges of the Act is that FDA prevent false and misleading labeling. The manner in which FDA does that is through analytical methodology in 99% of the cases. There are a few cases that have cropped up very recently where analytical methodology has not advanced as far as food development technology, and we don't have specific tests. I'm speaking specifically of the RBST issue.
Label disclosure: what type of labeling would be necessary to accommodate the celiac patient? How much labeling is necessary to assist them? Is it that gluten-free is the only type of labeling that should be permitted, or if a threshold level is determined, can reduced gluten be an alternative label statement that can be made? And the type of nomenclature that is very akin to label disclosure. And just to reinforce what I've already said, the U.S. is actively involved in the Codex process. It is likely because of the recent move toward international harmonization, NAFTA and GATT, that once a world standard is elaborated, the U.S. will move forward in elaborating similar standards for gluten-free foods.
Thank you. Any questions?
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