Waiting on FDA

Hello!

I hope that 2016 is off to a good start for you and your business and that you are looking forward to great new things!  While we look forward to seeing what 2016 will bring, many industries continue to wait for action from FDA.  I have listed just a few topics that various industry sectors hope to have clarified in 2016 below.

Foods

It has been two years since FDA proposed dramatic changes to nutrition labeling regulations (http://tinyurl.com/jjvls5q) .  Will the final rule require that ‘Added Sugars’ be listed in the nutrition facts box as originally proposed?  Industry has objected to this particularly since the amount of sugar added to jams, applesauce, etc. can vary with the inherent sweetness of the fruit. Since there is no lab test that can distinguish between naturally-occurring and added sugars, it is difficult to understand how FDA, which prides itself on being a science based organization, can ensure compliance with this rule.

Restaurant Menu Labeling: The publication of the final rules for calorie declarations on restaurant menus was delayed in 2013 and then in 2015 the compliance date for this regulation was delayed by one year to December of 2016.  Will chain restaurants really be required to post caloric values on their menus and menu boards?  While seemingly simple, there are genuine challenges with complying with this rule.  First, the accuracy required by the regulation could be tough to meet since even though restaurants are careful about portioning, there is variation.  Second, the regulation requires chain restaurants to list the calories on alcoholic beverages but the wine, beer and spirits industries are not required to provide calorie information. How is a restaurant supposed to comply? (See more on the rule: http://tinyurl.com/j7vwkgo.)

Pet Foods: In 2007 Congress mandated that FDA take over regulation of pet food.  Since that time FDA has been working with State pet and animal food regulators to come up with ingredient definitions that would meet FDA criteria.  As that progresses, FDA’s Center or Veterinary Medicine is scheduled to publish draft guidance documents that pertain to the pet food industry:

Animal Food Current Good Manufacturing Practices

Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

Human Food By-Products for Use as Animal Food

Dietary Supplements

It has been four and a half years since the first draft of the proposed guidance on New Dietary Ingredients was published (http://tinyurl.com/jtuqe4r) .  In 2013 FDA has proposed that the final rule would be published in 2014.  We are still waiting but it could be published any day!

Over the Counter Drugs

The FDA monograph that covers hand sanitizers and antibacterial soaps and body washes has been tentative since 1994.  In 2010 a lawsuit was filed to try to force FDA to finalize the monograph.  In December of 2013, FDA published a proposed rule stating that there was not sufficient data to support the safety of these products and that additional data on both safety and clinical benefit was required (http://tinyurl.com/z26bgs4).  The comment period closed in June of 2014 but no final rule has been issued.

Homeopathics

Both the FDA and FTC held hearings in 2015 looking into the regulation of homeopathic medicines.  The tone of these hearings made it very clear that both agencies view homeopathic products as quackery and would like to change the regulatory framework for homeopathic products.  Under the current policy, homeopathic products that comply with the Homeopathic Pharmacopoeia of the United States (HPUS) may be marketed in the US.  Unfortunately, some companies have introduced products that do not comply with HPUS to the market.  It seems that this is due, at least in part, to FDA’s complete failure to enforce the current regulations that apply to homoepathics.  This industry is waiting to see whether it will have a place in the US marketplace.

Cosmetics

Will the voluntary cosmetic registration and GMP program become mandatory? For years there have been bills introduced in Congress to more tightly regulate the cosmetic industry.  Discussions on Cosmetic Safety Legislation between the FDA and the cosmetic industry broke down in 2014 (http://tinyurl.com/hkmzhg7). Will we see fundamental changes to the way cosmetics are regulated in 2016?

It can be difficult to keep up with all the possible regulatory changes that can affect your day to day operations.  My associates and I work hard to stay abreast of FDA regulations, policies and related issues so we can help you stay compliant. Contact us with your questions and we’ll do our best to keep you up to date on FDA’s activities.

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.

Regards,

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

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