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
 

New Proposal on Antibacterial Soaps

Greetings!

On Tuesday, December 17, 2013, FDA published a proposed amendment to the tentative final monograph for topical antiseptic/antimicrobial products (http://tinyurl.com/qbatlul). The proposed rule addresses the formulation of “consumer antiseptic products intended for use with water” or in laymen’s terms, antibacterial hand and body washes.

Products intended to kill bacteria and other microbes are regulated as drugs by FDA.  Such products sold over the counter (without a prescription) must conform to FDA monographs that detail the ingredients, concentrations and labeling that is to be used on over the counter drug products of a given class.  The process by which a monograph becomes final involves a great deal of data review; proposed rules; public comments and resolution of those comments with FDA’s mission to protect public health.  In the case of topical antimicrobial products the process stalled in 1994 with publication of a so-called “tentative final monograph” (TFM) that questioned the safety and efficacy of a number of common active ingredients in those products.

In April of 2011 we wrote about (http://tinyurl.com/pexls8k) certain regulatory actions FDA took based on the tentative final monograph and noted that a lawsuit had been filed in 2010 that sought to force FDA to finalize the monograph.  The lawsuit was filed by the National Resources Defense Council and less than one month ago FDA entered into a consent decree to finalize the monograph in a timely manner. Tuesday’s proposed rule is a result of this consent decree.

The rule proposes that additional safety data is necessary to support the use of consumer antiseptic wash active ingredients and that the active ingredients must also have data demonstrating a clinical benefit over nonantibacterial soap and water.  The proposed rule states in part,

“Several important scientific developments that affect the safety evaluation of these ingredients have occurred since FDA’s 1994 evaluation of the safety of consumer antiseptic active ingredients under the OTC Drug Review. New data suggest that the systemic exposure to these active ingredients is higher than previously thought, and new information about the potential risks from systemic absorption and long-term exposure have become available. New safety information also suggests that widespread antiseptic use can have an impact on the development of bacterial resistance.”

The document also discusses some of the underlying concerns for these types of products:

“Since the 1994 TFM was published, new data have become available indicating that systemic exposure to topical antiseptic active ingredients may be more than previously thought. Systemic exposure refers to the presence of antiseptic active ingredients inside and throughout the body. For example, triclosan is an antiseptic active ingredient commonly found in consumer antiseptic hand and body wash products. It is absorbed through the skin and has been found in both human breast milk and urine. Further, triclosan has been found at relatively consistent levels in urine samples collected from a representative sample of the U.S. population since sampling began in 2003. We believe that the consequences of this systemic exposure need to be assessed.”

The document goes on to discuss the data gaps for several of the active ingredients; gaps that must be filled in order for the products to remain on the market in the future. Over 20 ingredients that require additional safety and efficacy data are listed.  Some commonly used ingredients included on the list are Benzalkonium chloride, Benzethonium chloride, Triclosan, Triclocarban, Hexylresorcinol, Povidone-iodine Fluorosalan, Hexachlorophene, Methylbenzethonium chloride and Phenol.

So how long does industry have to submit safety and effectiveness data? As outlined in Hyman, Phelps and McNamara’s Law Blog of November 28, 2013 (http://tinyurl.com/owp928g), the consent decree detailed a timeline that stipulates that the final monograph must be published by September 15, 2016. In the proposed rule FDA has stated that the effective date for compliance with what would be the new monograph would be one year after publication of the final rule, which means September 15, 2017 if the timeline is met.

FDA’s proposal will be costly to industry and many in the public will be sorry to see changes to highly favored products.  It will be interesting to see which ingredients pass muster.  In the meantime, Americans can reduce their exposure to the ingredients of concern by following the Center for Disease Controls instructions for hand washing with nonantimicrobial soap: http://www.cdc.gov/features/handwashing/.

As always, the associates of FDALabels.com and Bioscience Translation & Application are ready to assist you with your FDA regulatory questions. Contact us today at info@FDAlabels.com or info@BioTransApp.com. I you find our posts informative, consider visiting 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 and yours as we approach 2014!

Sincerely,

Evelyn & Associates

Bioscience Translation & Application     www.BioTransApp.com

FDALabels.com                                                www.FDALabels.com

Services of Cadman Consulting Services, LLC

Will December Bring New Proposals for the Dietary Supplement Industry?

Hello and Happy December!

FDA has been busy in the past few months, publishing several draft guidance documents and proposed rules for food safety—including a proposal that would ban partially hydrogenated oils in foods.  They also published updated guidance on cosmetic GMPs but have been relatively quiet about dietary supplements.  However, in September FDA’s Center for Food Safety and Applied Nutrition (CFSAN) published their “Plan for Program Priorities, 2013-2014” that included quite a list of goals for the dietary supplement program (http://tinyurl.com/nx6hsse). Since there are less than 30 days left in 2013, it will be interesting to see whether FDA will publish a flurry of proposed rules or miss their proposed deadline.

CFSAN’s overall plan for the dietary supplement industry is to “take steps to improve the safety and labeling of dietary supplements and the supply chain.”  It is interesting that the supply chain was mentioned since many dietary supplement manufacturers have complained that the dietary supplement GMPs do not extend to the suppliers, making it difficult for manufacturers to convince raw material suppliers of the importance of good documentation and record keeping that would help manufacturers comply with the GMPs (http://tinyurl.com/lj3z35f).

The CFSAN Plan for Program Priorities goes on to list 5 planned steps to address the safety and labeling of dietary supplements:

     1.       Modernize the postmarket surveillance system for regulating dietary supplements. This was a recommendation from the Department of Health & Human Services Inspector General’s 2012 report, “Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements” (http://tinyurl.com/keq4b27). By the way, this document details a study in which the Inspector General’s Office reviewed label claims and the manufacturer’s substantiation dossiers for 72 dietary supplement products.

      2.       Develop and implement risk-based compliance and regulatory strategies to address dietary supplement safety issues.  FDA typically takes a risk-based approach in their oversight and regulatory enforcement actions in regulated industries.  In the past FDA had indicated that they were particularly interested in monitoring the marketplace for claims relating to cancer, diabetes and influenza H1N1; they also watch for supplements that claim to affect memory, sexual function and weight loss.  It is unclear whether FDA will publish their regulatory strategies but we will be watching for updates to their compliance policy and inspection manuals.

     3.      Publish revised draft guidance on new dietary ingredients (NDIs) to increase premarket oversight of dietary supplements.  This highly anticipated guidance could prove to be very interesting.  The first draft was published in July of 2011.  FDA received over 12,000 comments on this document that appeared to the dietary supplement industry to be a substantial overreach by the agency that in effect, would put into place a premarket approval process for dietary supplements; a proposal that appears to violate the enabling legislation of the dietary supplement regulations.  It is unlikely that publication of the revised draft guidance would be received as good wishes for a prosperous new year by industry.

    4.      Publish final guidance on new dietary ingredients (NDIs) to increase premarket oversight of dietary supplements.  While this step is set for 2014, the short timeline indicates that the agency does not expect as many comments as there were for the first draft.  Perhaps they have thoughtfully considered the industry’s previous comments and the document will be something that both industry and regulators will find workable.

    5.      Publish final guidance to help dietary supplement and beverage manufacturers and distributors determine whether a liquid food product (such as energy drinks) may be labeled and marketed as a dietary supplement.  In December of 2009 FDA published a guidance document on “Factors that Distinguish Liquid Dietary Supplements from Beverages…” (http://tinyurl.com/nxjuswg).  FDA issued the guidance at a time when many ‘functional beverages’ were making their way to store shelves.  The apparent aim was to rein in the industry; however the plethora of liquid products available that claim to be dietary supplements but look like beverages is testament to the fact that the 2009 guidance has been largely ignored.

If CFSAN does publish all those proposed documents, we will do our best to keep you up to date without inundating your inbox.  In the meantime, the associates at FDALabels.com and Bioscience Translation & Application are ready to help you ensure that your products are compliant with FDA regulations so that you can enjoy uninterrupted market success.

As always, we hope you find these occasional updates interesting. Please 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

FDA's New View of Partially Hydrogenated Oils

On November 7, 2013 FDA published a ‘Request for Comments and for Scientific Data and Information’ regarding the use of partially hydrogenated oils in foods.  The FDA has reviewed the scientific data and has determined that there is no longer scientific consensus on the safety of partially hydrogenated oils due to the presence of artificial trans fats in those oils.  (Note that fully hydrogenated oils do not contain trans fats.)  Since there is not a consensus on the safety of partially hydrogenated oils, FDA is poised to declare that these oils as no longer generally regarded as safe (GRAS).  Once the GRAS status is so rescinded, partially hydrogenated oils would not be allowed in food products sold in the US.  

Partially hydrogenated oils were invented in the 1930’s and have been considered GRAS since they were in common use prior to the 1958 Food Additives Amendment to the FD&C Act.  It was even thought that partially hydrogenated vegetable oils were ‘healthier’ than dairy and other animal fats that they replaced in many products; particularly baked goods.

Oils are partially hydrogenated to increase their solidity and melting temperature and to increase the shelf life of the products they are used in.  These effects are all gained when the double bonds in unsaturated vegetable oils are converted into single bonds by the addition of hydrogen.  Partially hydrogenated oils can result in some trans fat bond conformations that are not readily broken down by the body’s enzymes, leading to build up of these fats in the body. 

When FDA began requiring that the amounts of trans fatty acids be declared in the nutrition facts panel in 2006, many food products were reformulated just enough to bring trans fat levels below the 0.5 gram threshold of declaration.  Many consumer groups were outraged that 0.499 grams of trans fat were required by regulation to be declared as 0 grams of trans fat and FDA has been pressured to take further steps since then.  A suit was filed in California seeking to force FDA to take steps to remove trans fat from the US food supply. 

Most of our clients don’t use trans fatty acids. However, in the course of our detailed label and ingredient reviews, we have sometimes found that ingredient suppliers were not being entirely upfront with their customers.  Some only provide nutritional information on a very small amount of their fats and oils. In doing so, they can list trans fats as zero. So what is a food-producer to do? 

      1.      Understand that it is only artificial trans fats that are harmful and they come from partially hydrogenated oils.

      2.      Always, always, ask for detailed specifications and certificates of analysis for every ingredient in your product.

      3.      Read the specifications and certificates of analysis and ask questions about anything you do not understand.

      4.      Write detailed specifications for your product that ensure that only the quality of ingredient you want is used in your product so that it will not trans fats or any other ingredient/component your customers may wish to avoid.

You can read more about FDA’s proposal to rescind the GRAS status of partially hydrogenated oils.  This link will take you to a summary aimed at consumers: http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm373925.htm .  This link will take you to the full announcement in the Federal Register: http://www.gpo.gov/fdsys/pkg/FR-2013-11-08/pdf/2013-26854.pdf.

As always, please post a comment to this blog with your questions on labeling and other FDA regulations.

Regards,

Evelyn & Colleagues
FDALabels.com                                      www.FDALbels.com
Bioscience Translation & Application    www.BioTransApp.com

Please 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.