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

Alaskan Native Art, Structure Function Claims and the FTC

Late last summer while visiting the Alaska State Museum in Juneau,  a postcard with a photo of a decorated canoe caught my eye.  On the front it said, "Genuine Alaskan Native Art" and on the back was a blub about the Federal Trade Commission (FTC) and  FTC information on Alaskan Native Art. There are specific guidelines on when terms such as 'Alaska native' can be used.

The FTC has recently gotten the attention of the food and dietary supplement industries by requiring two clinical trials for support of structure function claims.  No where in FDA regulations is this required.  Companies must have data supporting the claims they make as discussed in this FDA guidance but there is no stipulation that 2 clinical trials are required. FDA Law Blog has written very good pieces about the conflict between POM Wonderful and the FTC.

Today FDA published an announcement in the Federal Register  that the Office of Management and Budget had approved the agency's request to collect information from industry on substantiation of structure function claims.  It will be important for industry to respond with realistic information about the time and effort proper vetting of claims takes.

The associates at  FDALabels.com can review your claims and supporting data to help you determine if you have proper substantiation. 

FTC and Two Well-controlled Clinical Studies

In their settlement with Dannon over claims on DanActive and Activia, the FTC again evoked its standard of “two well-control clinical trials” to support structure function claims.  This standard was previously applied to Nestlé’s Boost® Kids Essentials drink and POM Wonderful Pomegranate Juice (POM is challenging FTC’s 2 clinical trial standard but the courts have yet to weigh in). 

FDA has written an extensive guidance document on claim substantiation without providing a definitive number of studies and instead relying on the interpretation of ‘adequate’ studies to support the claims.  FDA and FTC cooperate on cases involving claims on foods and supplements with FTC taking the lead in most cases.  Does this mean that FTC’s ‘two well-controlled clinical studies” will be the standard? Would ‘two well-controlled clinical studies’ prove to be a safe harbor for companies making structure function claims that do not directly or indirectly discuss disease states?  There’s just no telling but stay tuned.

The use of structure function claims on food products has been increasing and FDA is watching closely and cracking down on companies making claims with help from the FTC.  As a review, food products may include claims about the levels of nutrients that have an established RDI or DV as long as the levels of fat and sodium do not exceed set limits. They may also make certain health claims that link nutrients to disease prevention and ‘qualified’ health claims that have weaker support (see http://www.fda.gov/Food/LabelingNutrition/LabelClaims/HealthClaimsMeetingSignificantScientificAgreementSSA/default.htm)

and http://www.fda.gov/food/labelingnutrition/labelclaims/qualifiedhealthclaims/default.htm, respectively).

Food companies are getting into trouble when trying to make structure function claims. These claims discuss how the product or ingredients in it affect the normal, healthy structure or normal, healthy function of the body or its systems and do not discuss any drug-like properties or imply that the product in any way may prevent, treat, or cure any disease.  It is possible to craft claims that discuss the effects of the product on ‘normal’ conditions that are occasional, mild, temporary and self limiting such as occasional sleeplessness, occasional irregularity, and occasional indigestion.  All claims must be truthful, not misleading and backed by scientific evidence.

We at Bioscience Translation & Application stand ready to review your claims and supporting data and to help you craft appropriate claims and we welcome your inquires on these and other topics relating to food regulations. Learn more atwww.BioTransApp.com

Warning Letter & Draft Guidance on Clinical Trials

Hello!

The FDA has been busy lately, issuing many guidance documents and warning letters.  Two that are of particular interest to the dietary supplement industry are a series of warning letters to companies marketing chelation/detoxification products (see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229320.htm) and a new guidance on when FDA permission is required to conduct a clinical study (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM229175.pdf)

The FDA press release about the warning letters on chelation products cites examples that were clearly marketed inappropriately due to claims being made about autism and heavy metal poisoning.  Other products were marketed as dietary supplements but were not made to be ingested.  FDA’s press release also provides insight into the agency’s objection to the term ‘detoxification’.  Many of the chelation products talk about removing heavy metals and pollutants and it is clear that FDA views any detoxification as a disease prevention or treatment process.  While these letters address chelation, anyone wishing to market product for colon health should also avoid the term ‘detoxification’.

The guidance document on clinical studies is also very relevant for dietary supplement companies.  All claims made about dietary supplement products must be substantiated with scientific studies. Traditionally, the industry has relied upon a collection of studies on individual ingredients to support claims made on a product consisting of many ingredients.  Recent FDA and FTC enforcement actions indicate that regulators from these agencies believe that studies should be conducted on the final product in order to make claims.  Recent findings from the National Advertising Division of the Better Business Bureau, which reviews food and dietary supplement product claims, support this view. 

Back to the new guidance:  A quandary for the industry is presented by the newly published guidance which notes that if a study has an endpoint that looks at the effect of the dietary supplement on a disease condition, then FDA requires submission of an Investigational New Drug (IND) application.  However, it seems to me that submission of an IND would in effect mean that the company conducting the study has declared that their product is a drug and not a dietary supplement.  The net effect is that studies must be carefully designed and the subject population carefully screened to avoid running afoul of dietary supplement regulations. 

The good news is that the guidance is a draft and FDA is seeking public comments. It will be very important for dietary supplement manufacturers to pay attention to this issue and support efforts by trade groups to fight back.  Otherwise, this guidance could be a small step that could dramatically effect what dietary supplement products will remain in the marketplace. 

I plan to discuss this guidance with two attorneys who will be speaking on Dietary Supplement Claim Substantiation at the Regulatory Affairs Professionals Society conference sessions I am chairing next week in San Jose, CA.  http://s36.a2zinc.net/clients/raps/annual10/public/SessionDetails.aspx?SessionID=26 

If any of you will be at the conference or in the area, please let me know so that we can meet.