Search This Blog

Thursday, February 27, 2014

Proposed Changes to the Nutrition Facts and Dietary Supplement Facts Boxes



You’ve no doubt heard the news today that FDA is proposing a number of changes to the Nutrition Facts and Dietary Supplement Facts boxes that appear on US products.  The proposed rules are based on review of the state of Americans’ health, dietary patterns and newer understandings of nutritional science. The official announcement will be made at 3:00 pm Eastern Time and the rule is only proposed at this time and will not be in effect for about two years but I’ve spent some time this morning reviewing the proposed rule and thought you might be interested in a few of the highlights:
  • 1. The number of calories present in food and dietary supplement products will be much larger—larger than the current “Nutrition Facts” title.  The number of servings per container will be much larger as well. (see image below).
  • 2. The “%Daily Value” declaration would be moved to the left side of the panel.
  • 3. There is a proposal to eliminate the declaration of Calories from fats from the facts boxes.
  • 4. FDA wishes to require the declaration of “added sugars” in addition to total carbohydrates and the levels of naturally-occurring sugars.  This particular proposal will require excellent record keeping by manufacturers and distributors since there are no analytical methods that can differentiate between naturally occurring and added sugars.
The imges below are from the FDA Proposed Rule:
                          Current Facts Box                          Proposed Facts Box
                            
  • 5. There are some changes proposed to the RDIs and Percent Daily Values for some nutrients and to the units used to           express others.  Sodium's RDI would decrease from 2400 mg to 2300 mg per day. The fat soluble vitamins, A, D, E and K would now be expressed in milligram or microgram amounts rather than the current (and confusing) International Units. The RDI for calcium would be increased from 1000 mg to 1300 mg. See table below for details except that for some reason sodium was left out of this table.
  • 6. The proposed rule would require the mandatory declaration of vitamin D and potassium, retain the current mandatory declaration of calcium and iron and make the declaration of vitamin A and vitamin C voluntary.
  • 7. FDA also proposes that records be kept in support of label declarations of dietary fiber, sugars that undergo fermentation (including those in yeasted breads), various forms of vitamin E, and folate and folic acid.  The proposal would require maintenance of such records for two years.
The Table of Current and Proposed RDIs below is taken from FDA's Proposed Rules:
                                                          
It is important for manufacturers to consider how the proposed rule would affect their businesses and to consider submitting comments to FDA regarding the proposed rule.  We will provide updates and insights as the process moves forward and in the meantime can help you with the current regulations.

As always, we hope you find these occasional updates interesting.
If so, you may use this link http://eepurl.com/Imbjv to subscribe to our occasional email newsletters regarding FDA regulations and other topics of interest to FDA-regulated companies.  We 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.

All the best to you!
Evelyn & Associates
www.FDALabels.com
www.BioTransApp.com
 

No comments:

Post a Comment