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Monday, October 6, 2014

Updates for Food & Dietary Supplement Companies

I recently participated in the FDA /Joint Institute for Food Safety and Applied Nutrition (JIFSAN Food and Nutrition webinar.  The webinar covered topics including food labeling, infant formula, medical foods, color additives, partially hydrogenated oils and dietary supplements.  Most of the presenters that talked about labeling regulations focused on the proposed changes to the nutrition facts box, which we highlighted several months ago (  I want to share with you a few things I found interesting. 
I had heard some rumblings that the yet to be published final rule would very closely resemble the proposed rule and after listening to the FDA staff presentations, I expect that to be true.  As I read the proposed rule when it was first published I focused on the proposed changes and not FDA’s rationale for the various proposals.  The webinar presentations highlighted the rationale behind the proposals, convincing me that the agency is confident of the merits of the proposed rule and that much of it will remain intact in the final rule

For example, industry groups submitted comments on the proposed rule objecting to the proposal to declare total sugars and added sugars.  However, the proposal is rooted in the 2010 Dietary Guidelines for Americans that recommends reducing the intake of calories from solid fats and added sugars.  The presenter, Crystal R. Rivers of FDA’s Nutrition Programs in the Office of Nutrition, Labeling and Dietary Supplements, stated that on average, Americans get 16% of their total calories from added sugars and noted that labeling added sugars would encourage food manufacturers to reduce added sugars and help Americans to identify products with added sugars; compare products for amount of “added sugars” and reduce extra calories consumed by Americans.

Another speaker, Cherisa Henderson, Nutrition Programs Staff, Office of Nutrition, Labeling and Dietary Supplements, talked about the proposal for dual nutrition labeling that would list the calories
 and nutrients both a single serving and in the entire package for products that “can reasonably be consumed in a single-eating occasion”.   The proposal would mean that any product with 4 or fewer servings per container would list the nutrition facts per serving and for the whole container. Ms. Henderson presented findings from consumer studies that demonstrated that consumers were more aware of serving sizes and calories when both sets of information were presented.  FDA prides itself on being a science based organization and based on the data presented, I expect that FDA’s proposal to list the nutrition data for entire packages to be in the final rule.

The FDA presenters were repeatedly asked when various final rules on Food Safety Modernization and nutrition labeling would be published.  None of the speakers would venture a guess and one even said, "Hopefully in my lifetime."  We'll let you know as soon as we know.

Renew Food and Dietary Supplement Facilities Registration Now!
This was not mentioned in the recent webinar but it is time to renew ALL food facility registrations. This includes registrations of dietary supplement facilities.  All facilities must register between October 1st and December 31st of each even numbered year.  So, it is time for all food facilities both domestic and foreign to  re-register.  Online registration can be completed by following the login link on this page:   To download forms for registration by mail, visit

It is my hope that you will find these occasional updates helpful.  If so, you may subscribe to the email newsletter version by visiting  I send messages targeted to the dietary supplement, cosmetic, food, OTC drug and medical device industry sectors.  You may subscribe to one or all of the newsletters and you may unsubscribe at any time. 

As always, my colleagues and I would be please to help you with product labeling, facility registration or other FDA compliance questions.  Contact us today by replying to this post.

All the best to you!
Evelyn & Associates

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