Updates for Food & Dietary Supplement Companies

I recently participated in the FDA /Joint Institute for Food Safety and Applied Nutrition (JIFSAN http://jifsan.umd.edu/) 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 (http://tinyurl.com/me9rekg).  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.

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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 1^st and December 31^st 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: http://tinyurl.com/kpb4nkj   To download forms for registration by mail, visit http://tinyurl.com/momm97g.

It is my hope that you will find these occasional updates helpful.  If so, you may subscribe to the email newsletter version by visiting http://eepurl.com/Imbjv  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

www.FDALabels.com 

www.BioTransApp.com

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

FDA on Sunscreens

In January we told you about some of FDA’s plans for 2011 (http://biotransapp.blogspot.com/2011_02_01_archive.html). The agenda listed 18 types of over the counter drug products that are the subject of proposed rulemaking or other agency review.  Back in June FDA completed one agenda item, review of proposed rules for sunscreen products, by publishing four documents:  a guidance document, a proposed rule, an announcement of proposed rulemaking and one final rule. This product sector has been subject to changing unclear regulation since 1978 when FDA first announced its intention to regulate sunscreen products as drugs rather than as cosmetics. Since that time much has been learned about both the effect of sun on the skin and how various sunscreens work.  This has led to a new labeling term for sunscreens: broad spectrum. To use this term sunscreen manufacturers will have to demonstrate through testing that their product reduces the effect of both UVB rays that cause sunburn and UVA rays that affect skin aging and contribute to development of skin cancer.    More information on this claim and the testing required to meet the claim can be found in the final rule: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14766.pdf .  This rule becomes effective June 18, 2012 and in addition to allowing the ‘broad spectrum’ claim, it also prohibits the use of the terms ‘waterproof’, ’sweatproof’ or ‘sunblock’..

In addition to this final rule FDA issued an advance notice of proposed rulemaking that seeks information on the safety and effectiveness of spray on sunscreens http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14768.pdf.  The agency also proposed limiting SPF claims to 50+ since there is insufficient data that an SPF greater than 50 actually provides greater benefit http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14769.pdf.

Because sunscreen regulations have been in flux for the past 23 years, FDA also issued a guidance document to provide industry information on the types of sunscreen products that may be marketed without risk of FDA enforcement action.  Many sunscreens currently on the market contain ingredients that FDA has not reviewed or approved.  The agency has not taken enforcement action against such products since there were no clear regulations to follow.  Now FDA is stating that products that contain ingredients that were listed in the (still) tentative final monograph published in 1999 (see list at the end of this message) and which have been tested for effectiveness using methods included in FDA rules published in 2011, 2007 or 1999 may be marketed without enforcement actions if they comply with the new rules on claims.

It will be interesting to see which of the other 17 OTC categories FDA tackles next.  Whether it is cough and cold medications, weight control, antacid, antimicrobial or skin protectant products, the OTC team at Bioscience Translation & Application will be working to remain up to date in order to provide our clients with top-notch regulatory support.  Contact us with your question regarding how your product is regulated by FDA.

Sincerely,

Evelyn Cadman and Associates

The following active ingredients were listed in the 1999 Tentative Final Monograph, with GRASE maximum concentrations as shown:

·       Aminobenzoic acid (PABA), 15 percent

·       Avobenzone, 3 percent

·       Cinoxate, 3 percent

·       Dioxybenzone, 3 percent

·       Ensulizole, 4 percent

·       Homosalate, 15 percent

·       Octinoxate, 7.5 percent

·       Octisalate, 5 percent

·       Octocrylene, 10 percent

·       Oxybenzone, 6 percent

·       Padimate O, 8 percent

·       Sulisobenzone, 10 percent

·       Titanium dioxide, 25 percent

·       Trolamine salicylate, 12 percent

·       Zinc Oxide, 24 percent

These ingredients may be used at these concentrations in combinations as long as each active ingredient contributes a minimum SPF of 2 to the finished product, except that avobenzone may not be combined with aminobenzoic acid (PABA), menthyl anthranilate padimate O, titanium dioxide, and zinc oxide.