Minutes
HL7 Structured Product Labeling for Food and Dietary Supplements
March 30, 2016
Attendees:
Present / Name / Organization / E-mailX / Ayres, Elaine / HL7/NIH /
X / Leftwich, Russell / HL7/AAAAI/Intersystems /
X / Downs, Melanie / AAAAI/University of Nebraska at Lincoln /
Green, Todd / AAAAI/Children’s Hospital of Pittsburg /
X / Mitchell, Linda / AAAAI/Asthma and Allergy Foundation /
X / Oren, Eyal / AAAAI/Allergist - MA /
X / Skolnick, Helen / AAAAI/Allergist - NJ /
X / Venter, Carina / AAAAI/Cincinnati Childrens /
X / Young, Michael / AAAAI/Harvard /
Conference Call Information:
1-866-723-1827, passcode 2826113
Web Meeting Info (does not include audio connection)
http://www.webex.com
Meeting ID 193 128 608 (no password).
Direct Meeting Link: https://meetings.webex.com/collabs/#/meetings/detail?uuid=M8B9ZKDZAIIKHBGUAR299G14AE-4MOF&rnd=548277.12942
Project Wiki: http://wiki.hl7.org/index.php?title=Structured_Product_Labeling_for_Food_and_Dietary_Supplements_(SPLr8) (Note you must create a free HL7 account to access)
AGENDA:
1. Introductions
2. Review of project purpose and goals
3. Review of requirements and current information on substances
4. Next steps and timelines
Minutes:
After group introductions, Russ and Elaine provided background on the SPL project.
Background slides were reviewed:
This SPL for Food and Dietary Supplements is based on the current standard used for drugs. The creation of the standard does not guarantee the food manufacturers will accept and use the standard, nor does it imply that the federal government will embrace the proposed standard. However, there is no current standard for the electronic transmission of food or dietary supplement labels, and it was noted that when changing regulations, it is important to have a standard to point to.
A review of international allergy regulations for food labels can be found in the article by Allen et al. World Allergy Organization Journal 2014, 7:10 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4005619/
Current DRAFT spreadsheet of requirements:
As the group reviewed the current requirements spreadsheet, the following points were mentioned:
1. The listing of food substances included must be actionable. So for example, the word “seafood” is not actionable, whereas a specific crustacean shellfish such as shrimp is actionable.
2. The ability to capture the contamination of food and statement about potential cross-contamination is necessary.
3. The ability to track foods made in a contract facility or by a contractor may mask potential contamination issues. The ability to track the provenance of ingredients and sub-ingredients is necessary.
4. The review of the ingredient spreadsheet (tab 6) included a review of the current US regulations. The group was asked to provide further clarification on the following items:
a. Sulfites – is the inclusion of over 10 ppm sufficient as per the current literature or should the requirement include the reporting of the presence of sulfites when less than 10 ppm?
b. In order to best represent the various ingredients in a product, would a use of subcategories be helpful? For example an ingredient list would be categorized as:
i. Food ingredients
ii. Chemical ingredients
iii. Spices
iv. Dyes
v. …..
c. If spices and flavorings are to be specifically delineated, what are the specific spices, herbs and other flavorings that should be available?
5. The group then reviewed the allergen spreadsheet (tab 7) noting what is included in the current US regulation for labeling.
6. A spreadsheet of several sources of data on food substances was then reviewed.
a. Spreadsheet of foods:
b. The tab entitled VA and LIT review represents a list of foods from the VA (all caps) found on a review of allergy lists, and from a literature review of foods known to cause adverse reactions (added to the VA list as lower case). This list was used to augment the current list of food substances currently coded in SNOMED CT. Note that SNOMED CT is a hierarchy so for example specific tree nuts are children of the parent concept “tree nuts”.
c. The tab entitled “NIH” is a list of the frequency of food substances documented on the electronic health record allergy list.
d. The entitled “Cerner” is a list of food substances documented across Cerner electronic health record clients.
The next meeting of the larger HL7 SPL for Food and Dietary Supplements will be on Monday, April 25 at 4 PM EDT. All participants of this group are welcome to attend.
Specific Action Items:
1. Contact Dr. Stefano Luccioli who is a food allergy specialist and works at the FDA/CFSAN.
2. The group was asked to looked at the ingredient tab requirements:
a. Sulfites – is reporting of <10 ppm needed
b. What are requirements for reporting specific spices, herbs, flavorings, chemicals and dyes/coloring?
c. What are the specific recommendations for segmenting the ingredients by type e.g. food, chemicals, spices etc.?
d. In addition to the foods that must be reported by regulation, what are the other foods that the group would like to have manufacturers highlight or include in their electronic files?
e. If these specific foods are present in a food product, how would the group like these foods to be “highlighted” within the electronic file?
f. What is a reasonable “cut-off” for lists of food substances that should be made available to consumers?
3. The electronic file can carry other labeling messages related to allergen cross-contamination. Are there any specific requirements for these messages?
4. Is there any information that should be made available regarding non-packaged foods such as items like bulk foods, or fresh fruits, vegetables or fish/shellfish?
5. Consider not just allergens but any substances that may cause an adverse reaction or an intolerance.