What's not to like on Facebook? FDA's View

Sometimes FDA and other government agencies seem to be a bit behind the times but just last week FDA published the 19^th warning letter to mention Facebook.  Some of these letters from the past three years have also cited Twitter and Tumblr as sources of violative claims.  While these letters were primarily directed at dietary supplement companies, food, cosmetic and even drug companies can easily run afoul of FDA regulations on social media sites.

The most recent warning letter to mention Facebook, which was sent to Zarbee’s Inc. of Draper, UT. not only cites the company’s own Facebook postings but notes that “Zarbees “liked” the following comment...” and goes on to quote from customer posts noting how well the products worked for coughs, insomnia and other ailments.   In 2012 FDA had disliked the like that AMARC Enterprises, Inc. of El Cajon, CA gave to one of its customer’s posts about using their dietary supplement product for cancer.

The concept that testimonials presented on company websites and in other marketing materials are claims that are subject to regulatory scrutiny is not new.. In 2009 the Federal Trade Commission (FTC) issued a guidance document on testimonials and endorsements in advertising http://tinyurl.com/kdxnoqa  noting that they, like all marketing claims must be truthful, not misleading and supported by data.  FDA expands requirements for endorsements and testimonials to require that they comply with regulations on allowable claims.

All companies like positive comments and testimonials from customers.  While consumer comments are not a new phenomenon, the consumer’s ability to publish their comments to the world on social media sites is new.  So what is a company to do when a happy customer posts something that makes a claim that violates the regulations governing the compliant marking of their product?  

Several of the Facebook warning letters included this note from FDA,

“We advise you review all the information on your websites, including testimonials, social media websites (e.g., Facebook and Twitter), product labels, and other labeling and promotional materials for your products to ensure the claims you make are not in violation of the FD&C Act. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.”

The last sentence makes it clear: Companies must closely monitor their social media for compliance with FDA regulations. If a post about a product goes beyond what is allowed by regulation, the posts must be deleted or edited to become compliant.

·        If you are a dietary supplement company and a customer posts that your product cured an ailment or relieved pain; your product just became an unapproved new drug subject to FDA enforcement.

·        If you are a cosmetic company and a happy customer states that your oil healed their skin condition, that oil just became an unapproved new drug subject to FDA enforcement.

·        If you are selling an OTC drug and a customer posts about a use that is not covered in the approved labeling of your product, you are also subject to FDA enforcement action.

My colleagues and I can help you stay out of trouble by reviewing or monitoring your website and social media posts, as well as your product labels and brochures for FDA compliance.  Contact us with your questions.

It is my hope that you will 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. Please post any questions you may have.  My associates and I stand ready to help you with your FDA regulatory issues.

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

Labels as Tables of Contents

Greetings!

Last month I attended Supply Side West where my company, in conjunction with Nosco, Inc (http://www.nosco.com/), presented information on packaging, labeling and compliance.  I spoke to a small group of attendees about how labels function as the table of contents to information about your product; information that can guide an inspection of your manufacturing facility.  For instance, the net contents statement clues an inspector in on the type of equipment they will be reviewing: liquid or powder fill, tableting or encapsulation.  Whether the product is a food, drug, cosmetic or dietary supplement, the statement of identity, along with product claims, determines which regulations apply.  Claims used on the product label also convey the amount and type of data that should be on file to support the claims so that you can comply with the requirement that all claims be truthful, not misleading and supported by data.

If the product is a dietary supplement, the supplement facts box outlines the manufacturing process.  If the facts box lists a proprietary blend, then the standard operating procedure or SOP should reflect a blending step.  The supplement facts box can provide a list of herbs that may require identity testing or that may need to be the subject of a new dietary ingredient notification. Nutrition Facts boxes on foods or Drug Facts boxes on over the counter drug products guide inspectors to look for data to support the values declared or to demonstrate adherence to applicable monographs.The ingredient list is another place when an inspector may look for ingredients that may not be permitted in products marketed in the United States.

Finally, the signature line listing the name and place of business of the company introducing the product into the marketplace, assigns responsibility for compliance with labeling regulations, good manufacturing practices and adverse event reporting system. In the event an inspector finds something amiss, the signature line names the company that will get the 483 or possible warning letter.

With so much riding on the information listed on your product label, don’t ignore the importance of ensuring that your labeling is correct and complies with FDA regulations.   Visit our websites, www.BioTransApp.com or www.FDAlabels.com for more information on labeling or other FDA compliance issues.  This blog discusses issues pertinent to FDA-regulated industries. Post a comment to let us know if you would like to subscribe to occasional email updates targeted to your industry sector.


Copyright 2011 Bioscience Translation & Application

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.

Hand Sanitizers and OTC Drug Regulation

In August of last year we sent our cosmetic and OTC drug clients a link to a Hyman, Phelps and McNamara Law Blog Post about a lawsuit against FDA that sought to force the agency to finalize the tentative final monograph on hand sanitizers that has been “tentative” since 1994. This week FDA issued four warning letters to companies promoting hand sanitizers and other products as effective again MRSA (methicillin-resistant Staphylococcus aureus bacteria).  FDA issued a press announcement about these letters due to the concern that the public could be misled and subsequently harmed by the MRSA claims (http://tinyurl.com/4x6j777).  I find the warning letters interesting because of what we can learn about the regulation of over the counter drug products, particularly those under review by FDA or subject to tentative final monographs.

One of these warning letters went to Oh So Clean, Inc, doing business as CleanWell Company, which markets thymol-based hand sanitizers and sanitizing wipes. (Thymol is a constituent in the herb thyme.)  The warning letter demonstrates how FDA can enforce the stipulations of over the counter drug monographs that remain tentative. The warning letter results from FDA inspection of the company in August of 2010.  At that time CleanWell Company received a 483 letter detailing the violations FDA observed during the inspection. The warning letter issued last week notes that the company’s September response to the 483 letter “lacks sufficient corrective actions” and details FDA’s findings that the products are unapproved new drugs.

Based on the product labels and the company’s website, FDA categorizes the CleanWell products as “OTC topical antimicrobials” and cites the tentative final monographs (TFMs) for OTC healthcare antiseptics and OTC first aid antiseptics as the governing regulations for these products.  Interestingly, the response to an inquiry our company made to FDA in 2009 listed only the healthcare TFM as pertaining to hand sanitizers. Nevertheless, both of these monographs are being evaluated under FDA's OTC Drug Review process and the April 18 warning letter notes that “Pending a final monograph, the agency does not object to the marketing of OTC drugs that meet the formulation and labeling requirements described in the TFM.”  Unfortunately, the CleanWell “products’ formulation and labeling are not consistent with any of these TFMs.”  You can review the TFMs at http://tinyurl.com/3pxx464.

So what were the problems with these products?

First, the drug facts boxes identified Thymus vulgaris oil (thymol 0.05%) as the only active ingredient. The pertinent TFMs do not list this as an approved active ingredient but the First Aid Antiseptic TFM lists thymol in combination with eucalyptus, menthol, methyl salicylate and alcohol as an acceptable active ingredient. In addition, the product claims go beyond what is permitted by the tentative final monographs for antiseptic products. In particular, the claims of effectiveness against MRSA are non-monograph. The only way to make claims outside of those detailed in the monographs is to undertake clinical trials in order to gain FDA approval for new over the counter drug claims.

Even if thymol alone were an acceptable active ingredient for this type of OTC product, the company’s own website and other labeling state that active ingredient used in the products is a blend of essential plant oils.  FDA refers to incorrect labeling such as this as “misbranding”.

The warning letter further cites violations of good manufacturing practices, which render the products “adulterated” and orders the company to “cease manufacturing and distributing all your unapproved new drug products” and to take corrective action and respond to the warning letter within 15 working days. This is undoubtedly a real blow to products that were available in several well-known retail outlets.  

Similar problems were noted in the other warning letters about MRSA claims—simple failure to follow the monographs, which detail how to formulate and label over the counter drug products.  It is our view that timely and competent review of the product labels and claims could have helped these companies identify the issues cited by FDA and remain active in the marketplace.  Is your product compliant with applicable FDA regulations or has a slight tweak of the marketing materials skewed your claims beyond those permitted?  Let the Bioscience Translation & Application team help you ensure compliance so your marketing plans are not disrupted by FDA enforcement activities.

We invite you to subscribe to our RSS news feed or to become part of our mailing list: http://www.biotransapp.com/contact.htm.

Johnson & Johnson Consent Decree: A lesson in Drug cGMPs

The folks at Pharmalot have written an article about the Johnson & Johnson consent decree (http://tinyurl.com/4bxxl44).  The article includes a link to the consent itself, which details the cGMP requirements FDA expects to see at the drug manufacturer's facility. 

The consent decree details the systems that need to be set up to ensure that the company's drug products are produced properly and are safe and efficacious. The document makes clear that the plant needs to build a quality system from the ground up and is evidence of the catastrophic QA failure that lead to the recalls and the consent decree itself.  

My purpose in posting this information is not to spread salacious gossip but to provide what I think is useful information.  In my view, the consent decree can be used as a checklist to review the cGMPs at your manufacturing facility.  If you are unable to download the consent decree, please leave a comment with your email address and I will send it to you. (Your email address will not be published.)

Bioscience Translation & Application
Translating bioscience innovation into profitable applications.
www.BioTransApp.com

FDA's Agenda for 2011

Hello!!

I hope that the first 2 months of 2011 are going well for you and your business.  The information below was published in the Federal Register on December 20, 2010 but being that it is FDA’s published regulatory agenda, it is pertinent to any company regulated by FDA and provides a look at changes to anticipate. 

The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require that government agencies publish an inventory of rulemaking actions under development semi-annually so that we, the public, may be aware of and comment on the actions proposed on our behalf. (Not sure whether to grin or grimace here but that’s the story.)

There is something for everyone here.  FDA has been working since the 1960’s to update the monographs that regulate over the counter drugs—many of those remain on the agenda for 2011. In 2010 the agency proposed drastic changes to the process for medical device approvals and more ideas are noted on the agenda below.  Other highlights include upcoming rules on food labeling, infant formula GMPs, pet food labeling, and the use of cattle-derived ingredients in cosmetics as well as proposed rules affecting prescription drugs and biologics. New areas of FDA regulation—restaurant menus and tobacco products also made the agency’s ‘to do’ list.  The dietary supplement sector only makes the list for long term actions.

I have rearranged the agenda into product areas for your convenience.  To view the list as originally published visit http://www.gpo.gov/fdsys/ and search the Federal Register, Vol. 75, No. 243, December 20, 2010, p.79765-75767. The numbers preceding each listing are the sequence number and can be used to find more information about each rule when you visit the Federal Register. 

I would be happy to address questions you submit about these topics in future updates.  You may read past updates here on our blog, Bioscience FDA Update (http://biotransapp.blogspot.com/) . You are also invited to leave comments.

 

Food Pre-Rule Stage

311 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution

Food Proposed Rule Stage

328 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines 

329 Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants

Food Final Rule Stage

338 Use of Materials Derived From Cattle in Human Food and Cosmetics

339 Label Requirement for Food That Has Been Refused Admission Into the United States

Food Long Term Actions

355 Produce Safety Regulation .

356 Modernization of the Current Food Good Manufacturing Practices Regulation

Infant Formula Final Rule Stage

333 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements;

Records and Reports; and Quality Factors 

Dietary Supplement Long Term Actions

340 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements

Pet Food and Animal Feed Proposed Rule Stage

318 Import Tolerances for Residues of Unapproved New Animal Drugs in Food

320 Pet Food Labeling Requirements

321 Process Controls for Animal Feed Ingredients and Mixed Animal Feed

Cosmetic Final Rule Stage

338 Use of Materials Derived From Cattle in Human Food and Cosmetics

Over the Counter Drug Proposed Rule Stage

313 Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products

314 Over-the-Counter (OTC) Drug Review—Internal Analgesic Products

315 Over-the-Counter (OTC) Drug Review—Laxative Drug Products

316 Over-the-Counter (OTC) Drug Review—Sunscreen Products

317 Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products

322 Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products

Over the Counter Drug Final Rule Stage

334 Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products

335 Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products

336 Over-the-Counter (OTC) Drug Review—External Analgesic Products

337 Over-the-Counter (OTC) Drug Review—Skin Protectant Products

Over the Counter Drug Long Term Action

341 Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products

342 Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use

343 Over-the-Counter (OTC) Drug Review—Ophthalmic Products

344 Over-the-Counter (OTC) Drug Review—Oral Health Care Products

345 Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products

346 Over-the-Counter (OTC) Drug Review—Weight Control Product

347 Over-the-Counter (OTC) Drug Review—Overindulgence in Food and Drink Products

348 Over-the-Counter (OTC) Drug Review—Antacid Products

349 Over-the-Counter (OTC) Drug Review—Skin Bleaching Products

350 Over-the-Counter (OTC) Drug Review—Stimulant Drug Products

351 Over-the-Counter (OTC) Drug Review—Antidiarrheal Drug Products

352 Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products

353 Over-the-Counter (OTC) Drug Review—Certain Category II Active Ingredients

Medical Device Proposed Rule Stage

319 Laser Products; Amendment to Performance Standard

324 Unique Device Identification

327 General Hospital and Personal Use Devices: Designation of Special Controls for Infusion Pumps

Medical Device Final Rule Stage

331 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements

Tobacco Product Proposed Rule Stage

325 Cigars Subject to the Family Smoking Prevention and Tobacco Control Act

326 Cigarette Warning Label Statements

Prescription Drug & Biologics Proposed Rule Stage

312 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics 

323 Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products

Prescription Drug & Biologics Final Rule Stage

330 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products

332 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and

Lactation Labeling

Prescription Drug & Biologics Long-Term Actions

354 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and

Administrative Procedures.