Keynote presentations from the 2009 Allergen Bureau Conference

We were fortunate to have Dr Stefano Luccioli as our international guest speaker at the 2009 Allergen Bureau Conference. Dr Luccioli is the Senior Medical Advisor in the Office of Food Additive Safety (OFAS) in the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA). He gave three presentations, covering the following topics: Labelling Exemptions and Food Allergen Thresholds - the FDA experience; Allergen Advisory Labelling in the United States; Gluten-free and US regulations. These presentations are reviewed here in brief.

1. Allergen Advisory Labelling in the United States; Gluten-free and US regulations

Dr Luccioli began with a background on food allergen labelling statements in USA, plus a review of FDA activities relevant to allergen advisory labelling. The presentation took delegates through a time-line which began in 1996 with a Notice to Manufacturers from the FDA, through to the FDA Public Hearing on Food Advisory Labeling which took place in September 2008. The Food Allergen Labeling and Consumer Protection Act (FALCPA) has been in effect since the 1st of January 2006, and requires plain english labelling of food ingredients that contain protein from any of the 8 major food allergens (milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans). FALCPA was also intended to define ‘gluten free’ but does not address advisory labelling for unintentional introduction of allergens into products by way of cross-contact.

The public hearing in September 2008 aimed to determine under what circumstances manufacturers use advisory labelling, what type of advisory labelling is most effective in helping consumers avoid adverse allergic reactions and how advisory statements should be worded to be the most effective in communicating the likelihood that an allergen may be present in a food. The hearing provided a forum for international stakeholders, including the Allergen Bureau representing the Australasian food industry, the UK FSA, and the US food industry represented by the Grocery Manufacturers of America (GMA) and the National Confectioners Association (NCA) to discuss their perspectives and experience. The consumer perspective was also heard, with key data published by Hefle et al. (JACI 2007) providing graphical representation of buying behaviour in relation to precautionary labelling.
In summing up this presentation, Dr Luccioli stated that the FDA is reviewing public comments in developing a long term strategy to address the allergen labelling issues.

Note: the background information on the FDA public hearing has previously been reported here on the Allergen Bureau website.

2. Labelling Exemptions and Food Allergen Thresholds - the FDA experience

In this presentation, Dr Luccioli discussed the current exemptions from FALCPA, plus the criteria against which exemptions to the legislation could be granted. Current exemptions are limited to highly refined oils derived from one of the eight foods or food groups that require allergen labelling. Processes have been established whereby someone may file a notification or a petition in order to get certain foods or ingredients added to the list of exemptions. Briefly, a notification must contain scientific evidence demonstrating that an ingredient “does not contain allergenic protein”. A petition must provide scientific evidence to demonstrate the food or ingredient “does not cause an allergenic response that poses a risk to human health”.

In the period 2006-2008, 7 notifications,[milk (4), soy, fish, wheat] and 2 petitions [soy (2)] have been submitted. No new exemptions have been granted as yet, although one petition is still pending. The reasons for not granting the exemptions were discussed, with the primary failing being a lack of evidence to support the applicant’s claim. More information about the FDA regulations can be found here.

The process of assessing petitions and notifications raises the issue of allergen thresholds, and in this presentation Dr Luccioli discussed the pros and cons of an FDA document on the various approaches for considering allergen thresholds. Firstly, an analytical methods-based approach was described, with the cons listed as: test methods vary in accuracy, there are test kit validation issues, kits are not available for all allergens, and there is a risk of false negatives due to food matrix effects or sampling errors.

The safety assessment-based approach was then discussed. This approach is based on clinical tolerance levels, with double-blind placebo-controlled food challenge (DBPCFC) being the optimal method for gaining data as to the minimal eliciting dose of a given allergen. Several limitations to this approach were also listed, including lack of standardized allergen doses, selection bias (whereby the extremely sensitive individuals, and children are excluded from the studies), and experimental bias, where it is unlikely that ‘real world’ exposure will mirror that of the clinical setting.

Lastly, the risk-assessment approach was discussed. This was said to be the most scientifically rigorous approach as it considers risk, hazard, dose-response and exposure. There are still several ‘unknowns’ which restrict the use of the risk-assessment approach, and focus is currently on developing and using statistical models of risk. In the future, Dr Luccioli maintained it would be useful to correlate experimental minimal eliciting doses with the lowest observable adverse effect levels analysed from food products associated with consumer complaints. More information about the FDA document on Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food can be found here. <link to http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106108.htm

3. Gluten-free and US regulations

In his final presentation, Dr Luccioli gave an overview of coeliac disease, and discussed the past, present and future of gluten-free labelling in the USA.

The FDA conducted a review of scientific literature about the association between gluten intake and celiac disease, and in June 2005, issued a draft report entitled Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food which offered 4 different approaches that FDA could consider to establish a threshold level for gluten to define the term ‘gluten-free’.  Public comments on that draft were sought, and a public meeting was held in August 2005. The proposed rule: ‘Food Labeling; Gluten-Free Labeling of Foods’ was issued in January 23, 2007, with a 90-day comment period.

The FDA has now completed a review and analysis of public comments on the proposed rule, and will complete a safety assessment on gluten. A further Federal Register Notice will then be issued to share findings and to solicit public comments. Ultimately, the FDA expects to issue a final rule on gluten free food labelling, however several further steps are yet to be taken, including an experimental consumer research study on gluten free labelling.

The proposed rule on gluten free labelling can be accessed on the FDA website.