December 18, 2013
Earlier this year, the FDA announced plans to finalize guidance on “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering” (see 4.1.11 in the Center for Food Safety and Applied Nutrition (CFSAN) Plan for Program Priorities, 2013-2014).
Given that the last draft of the guidance was issued nearly 13 years ago, based on focus group research from the year 2000, the appropriate action toward finalization would be for the FDA to update the guidance and open a public comment period.
It is now mid-December, and FDA has shown no indication of doing either of these things. Therefore, we feel called to draw attention to the issue. We have sent the letter below to FDA Commissioner Hamburg, and we encourage food companies, retailers and consumers to submit comments of their own, calling for transparency, accuracy, and public engagement in this process.
Although FDA Guidance is non-binding, and (unlike a regulation) cannot be used to force labeling changes, we have seen firsthand that other government agencies rely on this guidance, even in its draft form. We therefore believe it is of the utmost importance that the final guidance be accurate, based on data from this decade.
The most important change that needs to be made is with regard to terminology. The 2001 draft guidance uses terms like “bioengineering,” while advising against the term “GMO.” The basis of this guidance is focus group data from 2000, which is completely obsolete at this point.
December 18, 2013
Margaret A. Hamburg, Commissioner
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
RE: Center for Food Safety and Applied Nutrition (CFSAN) Plan for Program Priorities, 2013-2014
Dear Commissioner Hamburg,
On behalf of the Non-GMO Project, North America’s leading third-party verifier of non-GMO food and products, we are writing to express concern over CFSAN program priority 4.1.11: Publish final guidance to help manufacturers who wish to voluntarily label their foods as being made with our without the use of bioengineered ingredients.
This priority is slated for 2013. Achieving that deadline would be unreasonable given that as of mid-December 2013, no current, relevant draft has been distributed upon which to base finalization. The existing draft guidance was originally published in January 2001. It cites focus group research from 2000, which has become so dated as to be completely obsolete. Particularly with regard to terminology, current research shows that over the past 12 years different terms have come to be recognized and preferred by the public. Namely, “GMO” has become by far the most well understood term, while words like “bioengineering,” which is recommended in the 2001 draft, are virtually non-existent in the current public discourse.
We appreciate the FDA’s commitment to updating the guidance, and respectfully request your assurance that this will only be done through adherence to a meaningful process. When the 2001 draft guidance was distributed, more than 50,000 comments were received, reflecting significant stakeholder interest and concern. In the intervening 12 years, engagement on the GMO issue has only grown exponentially.
As the directors of the Non-GMO Project, we are uniquely well-informed to comment on the marketplace realities that should be considered in updating this guidance. The Non-GMO Project represents more than 1,200 companies, 14,000 products, and well over $4.5 billion in annual sales. The Non-GMO Project Verified label is the fastest growing label in the natural products industry. Its popularity with consumers is further confirmed by our 234,000 person Facebook following as well as by the 150,000 unique monthly visitor average to our website. In both the marketplace and in our considerable public communications, we consistently see that “GMO” is the preferred and recognized term.
In light of the immense current stakeholder engagement, it would be a great disservice to American consumers and manufacturers to push through finalization of an outdated document, based on public input that is more than a decade old.
In order to finalize guidance that is both accurate and useful, new draft guidance should be developed using current data. This draft should then be circulated for public comment.
We respectfully request the opportunity to meet with you in person to further discuss this process. We also would like to extend our willingness to provide recent media analyses, focus group transcripts, survey results, and any other data that would be useful in developing an accurate and current guidance document.
The Non-GMO Project Board of Directors:
Corinne Shindelar, CEO
Independent Natural Food Retailers Association
Michael Funk, Chair and Co-Founder
United Natural Foods, Inc.
Dag Falck, Organic Program Manager
Nature’s Path Foods
Alisa Gravitz, CEO
Maureen Kirkpatrick, Standards Coordinator
Big Carrot Natural Food Market
Michael Potter, CEO
Judi Shills, Executive Director
Teens Turning Green
Mark Squire, Owner
Good Earth Natural & Organic Foods
Megan Westgate, Executive Director