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.

Claims in the News

Hello!

If you are tuned to news about regulatory issues you are likely aware of recent lawsuits being brought against companies for claims made on food products.  In one instance a mom in California is suing Nutella® over claims that the product is part of a healthy breakfast (http://www.foodnavigator-usa.com/Legislation/Nutella-manufacturer-faces-lawsuit-over-nutrition-claims). In another, the National Consumer League (NCL) has filed a complaint with the Federal Trade Commission alleging that the labeling and claims made on VitaminWater® product labels are “dangerously misleading” (http://www.foodproductdesign.com/news/2011/02/ncl-vitaminwater-ads-labels-are-dangerously-misle.aspx). This is not the first time complaints have been raised regarding VitaminWater® labeling.  Last year the Center for Science in the Public Interest (CSPI) filed suit claiming that the labeling of this product line included inappropriate nutrient content claims and further that the products were in violation of FDA fortification regulations.

These actions by groups and private citizens reveal a level of risk to companies making claims about their products that go beyond the typical risks from FDA and FTC that we regularly alert our clients to when reviewing their labels, brochures and websites.  It is rare that product labeling poses no risk and every company must determine the level of risk they are comfortable with.  It is common for companies to decide to push the envelope and take some risk since government enforcement actions are taken against only a small number of companies and while relabeling can be expensive, first offenses rarely result in fines.  Groups such as NCL and CSPI typically target large, high profile companies but the lawsuit by the private citizen against Nutella®, a product with a relatively small market share, made me sit up and take notice; particularly since the product does include nutrition information in compliance with FDA labeling regulations.  While the advertising tells the whole story—that Nutella® can be part of a healthy breakfast—the suit demonstrates that the consumer took only the highlight of the marketing message—healthy.  It will be interesting to see what happens with this case.  Will the standard that claims must be truthful, not misleading and supported by data have to be modified to account for consumers who do not listen to the whole message? 

While we cannot predict the outcome of these cases, we work to help our clients understand labeling regulations and the risks posed by the claims they make about their products.  We welcome your inquiries regarding claims, labeling and product development and hope to partner with you for your success.  Visit us at www.BioTransApp.com.

New FDA Update Blog

Hello!

For several years I have been sending occasional email updates on various FDA and sometimes USDA topics to clients of Bioscience Translation & Application (www.BioTransApp.com), a service of Cadman Consulting Services, LLC.  I frequently hear back that the information is helpful and I have decided to collect those messages in a blog.  I will also use this blog to comment on other regulatory issues that perhaps don't warrant an email.

I will be working to establish different pages for different regulatory sectors: Food, Dietary Supplements, Cosmetics, Medical Devices, Drugs, etc. so that you can easily find topics of interest.

I hope that you will find the information helpful and interesting!

Evelyn

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

Identity & Quality Testing for Dietary Supplement GMP Compliance

I hope that you have been well.  The FDA remains busy and last month I attended a conference that included a session on FDA enforcement and compliance for dietary supplements.  The speakers included Jennifer Thomas, acting director, Office of Compliance, CFSAN, US FDA; Ralph Tyler, chief counsel, Office of Compliance, US FDA and Eugene Thirolf, JD, director, The Office of Consumer Litigation, US Department of Justice, whose office prosecutes cases developed by FDA.

Two very interesting comments were made by Ms. Thomas:  First she noted that FDA plans to bring enforcement activities against dietary supplement manufacturers who use aseptic processing methods but are not properly registered.  This means companies that make liquid and gel form supplements in hermetically sealed containers.  Such operations must be registered with FDA’s office for Low-Acid and Acidified Canned Foods (http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/default.htm).  The name of this office may have lead many such producers to think the regulations did not pertain to them.  We have recently helped a company file the proper paperwork and we can help you too if needed.

The second very interesting comment by Ms. Thomas was, “…and don’t even think about using the word antioxidant on the label.”  During the question and answer period I asked Ms. Thomas what that comment meant.  She admitted to using a bit of hyperbole but went on to explain that FDA is adamant that only Vitamins A, C & E and the mineral Selenium (ACES) are antioxidants and that the agency would be cracking down on antioxidant claims used for other nutrients. Many of you have had conversations with me on this very topic.  I think it will literally take an act of Congress to get nutrients other than ACES recognized as antioxidants—so write your Congressmen!

My assistants and I continue to monitor FDA warning letters—many recent ones cite dietary supplement companies for failing to do testing to confirm the identity of the ingredients they are using. Don’t let this happen to you. To learn about identity testing you may wish to ‘attend’ the free webinar from Natural Product Insider:

Establishing Identity and Quality Testing Programs for Compliance with the Dietary Supplement cGMPs

Tuesday, December 14, 2010 at 2:00 PM EST

Companies that manufacture and distributed dietary supplements in the U.S. must now comply with final FDA current good manufacturing practices (cGMPs) related to the identity, purity, strength and composition of products. However, FDA’s initial inspections have found serious problems related to testing and documentation. During this Webinar, learn from the experts on how to improve approaches to identity and quality testing for GMP compliance. FDA’s Carl Reynolds will discuss component regulatory specifications and provide an overview of FDA expectation regarding this aspect of cGMP compliance; Frank Jaksch will discuss the importance of authenticated reference standards for identity testing; and Cynthia Kradjel will discuss how to develop FTNIR methods that are fit for purpose.

http://event.on24.com/eventRegistration/prereg/register.jsp?eventid=265144&sessionid=1&key=32B03820DD47F2A1BFC21B8C8FD289DA

As the end of year approaches we at Bioscience Translation & Application stand ready to help you meet your 2010 project goals.  Contact us today for help with FDA compliance questions on foods, dietary supplements, cosmetics and over the counter drugs. Visit us at www.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.

Recent insights from FDA Warning Letters

Once again I’d like to share information about FDA’s recent warning letters. This time several of the letters discuss the agency’s objections to certain claims—claims, which many of our have been cautioned about when we reviewed their labels and labeling.

The first involves the use of the claim “0 grams trans fat”.  In a warning letter to David’s Cookies of Fairfield, NJ, FDA stated that “0 grams trans fat” is a nutrient content claim and is “not made in accordance with the applicable requirements.”  There are no authorized nutrient content claims for trans fat. Many of you will recall our recommendation that the statement, “0 grams trans fat per serving” be used since it is a statement of fact.  You may read the entire warning letter at:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm224888.htm

There were two warning letters to large corporations regarding claims relating to green tea.

In their letter to Unilever regarding Lipton’ Green Tea, FDA took exception to claims made on the company website regarding links to green tea and heart health/cholesterol levels. The agency takes the position that Lipton is promoting the product as an unapproved new drug due to these claims.

(Read the letter at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm224509.htm)

Both the letter to Unilever and a letter to Cadbury regarding their Green Tea Ginger Ale discuss the agency’s objection to the use of the term “antioxidant” in relation to green tea.  FDA only recognizes Vitamin C, Vitamin A, Vitamin E and Selenium as antioxidants. We typically suggest that our clients discuss the ‘antioxidant activity’ of nutrients other than A, C, E and selenium.  The Cadbury warning letter regarding their Green Tea Ginger Ale can be found at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm224571.htm) .

These recent warning letters are interesting because they warn about claims that are really quite common in the US grocery market.  In fact, these claims that are so common that when we have warned our clients about them, they frequently say, “but everybody says that!”  These letters demonstrate that the agency is perhaps catching up with the marketplace. This is most likely because the 600 to 800 new inspectors hired a few years ago have mostly completed their training.

There are many things to consider when writing FDA compliant claims.  Armed with 12 years of experience with FDA regulations, we at Bioscience Translation & Application stand ready to help you understand the many nuances to this task. Visit us at www.BioTransApp.com