Minutes
HL7 Structured Product Labeling for Food and Dietary Supplements
March 30, 2016
Attendees:
Present
X
X
Name
Ayres, Elaine
Leftwich, Russell
X
Downs, Melanie
Green, Todd
X
X
X
Mitchell, Linda
Oren, Eyal
Skolnick, Helen
X
X
Venter, Carina
Young, Michael
Organization
HL7/NIH
HL7/AAAAI/Intersystems
AAAAI/University of
Nebraska at Lincoln
AAAAI/Children’s Hospital
of Pittsburg
AAAAI/Asthma and
Allergy Foundation
AAAAI/Allergist - MA
AAAAI/Allergist - NJ
AAAAI/Cincinnati
Childrens
AAAAI/Harvard
E-mail
eayres@nih.gov
rleft@pobox.com
mdowns2@unl.edu
todd.green@chp.edu
LMitchell@aafa.org
eoren11@gmail.com
HSkolnick@aol.com
Carina.Venter@cchmc.org
Michael.Young@childrens.harvard.edu
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=M8B9ZKDZAIIKHBGUAR
299G14AE-4MOF&rnd=548277.12942
Project Wiki:
http://wiki.hl7.org/index.php?title=Structured_Product_Labeling_for_Food_and_D
ietary_Supplements_(SPLr8) (Note you must create a free HL7 account to access)
AGENDA:
1.
2.
3.
4.
Introductions
Review of project purpose and goals
Review of requirements and current information on substances
Next steps and timelines
Minutes:
After group introductions, Russ and Elaine provided background on the SPL
project.
Background slides were reviewed:
International Food
Allergies.pptx
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:
Structured Product
Labeling for Food and Dietary Supplements V 1.0 2016 3 30.xlsx
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.
Original List of
Substance Causing Adverse Reactions 2013.xlsx
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 nonpackaged 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.