Issue of the Month
Tobacco Control Act: Equivalence Submission Deadline Expires

The Tobacco Control Act requires manufacturers of new or modified tobacco products to submit a premarket application and obtain authorization before they market their products. However, on January 5, 2011 the FDA issued Substantial Equivalence Guidance requiring that certain tobacco products introduced or changed between February 15, 2007 and March 22, 2011 be reviewed and approved by the agency in order to remain on the market. The deadline for submitting the substantial equivalence applications under section 905(j) of the Act was March 22, 2011.

“Substantially equivalent” means the products must be the same in terms of design features, ingredients, materials, heating source, composition and other characteristics to an existing predicate product. The product may also be equivalent if it has different characteristics but does not raise different questions about public health.

The guidance states that new tobacco products introduced to the market, and existing tobacco products that were modified between February 15, 2007 and March 22, 2011, must be substantially equivalent to products commercially available on February 15, 2007. Tobacco manufacturers who submit a substantial equivalence application by March 22, 2011 may continue to market their products unless the FDA determines that the product is not substantially equivalent to the predicate product. If tobacco manufacturers chose not to submit an application then they were required to remove their products from the market or the products will be considered to be misbranded or adulterated under the Act.

However, due to the limited time given to manufacturers to submit the 905(j) reports, the FDA is going to allow manufacturers, who acted in good faith to meet the March 22, 2011 deadline, a reasonable amount of time to supplement their initial submissions. A reasonable period of time will be defined by the FDA for each manufacturer on a case by case basis.

The FDA will now begin the process of reviewing all the 905(j) reports to determine whether the new product is substantially equivalent to a predicate tobacco product and to ensure the product is in compliance with the Act. The FDA has not given any indication as to how long the review process will take.

One of the goals of this process is to provide the FDA with detailed information regarding tobacco products so that they can assess any potential new risks to public health and prevent products that may be more dangerous from being marketed.

Now that the substantial equivalence period has expired, manufacturers that want to introduce a new product onto the market must submit an application and receive marketing authorization under section 910(c)(1)(A)(i) of the Act from the FDA prior to distributing the product.

Return to the Top of the Newsletter

FSMA Perspective
FDA Holds Listening Sessions on FSMA Implementation

Food and Drug Administration officials have hit the ground running as they set out to meet tight implementation schedules under the Food Safety Modernization Act. The agency held two public meetings—a one-day listening session on the FSMA and imports, at the FDA White Oak Campus in Silver Spring, Md., and a separate March 30-31 session that focused on the comparability to food safety systems and import practices, held at CFSAN’s headquarters in College Park, Md.

FSMA’s provisions relating to imports are arguably the most complex part of the new law and they are likely to be the most difficult ones to implement, including, for example, the establishment of the Foreign Supplier Verification Program under Section 301 and of the Voluntary Qualified Importer Program under Section 302. There are many questions to be answered—such as how the agency will know that an imported product is certified.

“We are looking at that right now,” said Sharon Lindan Mayl, senior FDA advisor on foods policy and counselor to Deputy Commissioner for Foods Mike Taylor, at the March 29 session.

Importers will have an accountability function as well as an administrative function under the FSMA, said Deputy Commissioner for International Programs, Murray Lumpkin. “We will have to see how the accountability part will work,” he said.

Third-party certification under Section 307 of the act raises many complex issues. For example, FSMA provides for transparency of audit results from third-party firms, so they would become part of the agency’s records, as do inspection reports. But it is not clear how this will work in practice.

The agency is also very interested in auditor competency. Participants in the March 29 session agreed that this is a key issue. As it develops an accreditation program for third-party auditors, it is likely that FDA will require auditors to have expertise and training that is specific to the products they are auditing.

The March 30-31 hearing explored the concept of “comparability” of food safety systems, which the regulators do not view as the same as “equivalence”--a term that has a history of use by the federal agencies in their dealings with their counterparts overseas. Use of the term comparability may allow FDA to break free of the very time-consuming procedures established for equivalence determinations.

Day two of the March 30-31 hearing focused on best practices for imports and it included presentations from the Canadian Food Inspection Agency, the New Zealand Food Safety Authority, and the Food and Agriculture Organization, among others. Although the participants in these listening sessions came away with many additional questions rather than answers, the general mood of both sessions was very positive and the agency plans to schedule a series of similar hearings on other components of the FSMA.

Return to the Top of the Newsletter

Who's Who at EAS
Meet EAS Senior Consultant Rik Atkinson

Walter (Rik) H. Atkinson III is an expert in validation of pharmaceutical products, with more than 25 years of experience in current Good Manufacturing Practices. Rik began his career as a process manager for vitamins and antibiotics at Hoffmann-La Roche. He later became a process manager for liquid vitamin blends, formulating more than 200 blends for the food, health care, and infant formula industry.

He served with Hoffmann-La Roche from 1992 to 1997 as a senior process manager, where he supervised liquid vitamin blends and vitamin A aldehyde processes. He joined Roche Vitamins Inc., in 1997 as a systems analyst and became a team leader at the company in the following year, where he provided production and compliance expertise for Lasalocid and vitamin C processes. From 2001-2002, he was Roche’s production supervisor for the immunosuppressive drug, Zenapax.

From 2002 – 2008, he was a senior consultant at AAC Consulting LLC (Kendle International Inc.), where he assisted pharmaceutical companies with active pharmaceutical ingredients, process equipment, utility and analytical instrument validation efforts and validation protocol review and approval. He joined the EAS consulting team in 2009 and now assists EAS clients with validation issues. In addition, he provides assistance in re-engineering, outsourcing, safety redesign, asset verification, activity-based management/costing, process expansion, process start-up, relocation, cost reduction and/or vendor-managed inventory.

“Rik’s thorough understanding of the needs of pharma companies, along with his vast technical knowledge and experience, make him a valuable asset for our pharma clients,” says EAS President Ed Steele.

EAS Welcomes Four New Consultants

EAS is pleased to announce the addition of Brian Lynch, John Marcus, James Warren, and Frank Mark to the EAS consulting team.

Brian Lynch (pictured right) is a former FDA microbiologist and consumer safety officer specializing in biologics. He joined the agency in 1974 as a microbiologist at the National Center for Toxicological Research in Jefferson, Ark. Most recently, he was a biologics specialist at the Montgomery, Ala., resident post for the agency’s Nashville/New Orleans District Office. He is also trained in HACCP, low acid canned foods and acidified foods.

John Marcus (pictured right) is another former FDA official who spent 30 years with the agency as a regulatory scientist, including 15 years as chief chemist in charge of the manufacturing and quality control staff office for new animal drug evaluation in the Center for Veterinary Medicine. He was a senior regulatory consultant for pharmaceuticals with Kendle Regulatory Affairs from1997 to 2006, when he left to work as an independent consultant.

James Warren, whose career in the pharmaceuticals industry has spanned more than 40 years, has been a pharma consultant since June 2004. From July 1998 through May 2004, he was chairman and CEO of Banner Pharmacaps in High Point, N.C., which specialized in custom encapsulated, prescription pharmaceuticals, OTC pharmaceuticals, and nutritional products. He began his career as a research pharmacist with Eli Lilly and Company in Indianapolis.

Frank Mark’s 30-year pharma career included seven years as an investigator with FDA’s Newark District Office, where he inspected food, drug and medical device establishments. He went on to spend 13 years in quality operations, research management and regulatory compliance at several pharmaceuticals companies. He has been a consultant for more than ten years.

“I am delighted to welcome Brian, John, Jim and Frank to our senior consulting team,” says EAS President and CEO Ed Steele. “They bring a wide range of skills and expertise that will be most helpful for our clients.”

Return to the Top of the Newsletter

What's New on FDA's Website
March Updates

Listed below are links to new additions to the FDA website for the month of March, 2011. Use of this section of EAS-e-News is intended to provide an "easy" way to keep current with FDA news and information.

• JOINT EPA/FDA STATEMENT: Update on Ongoing Monitoring March 30, 2011


• FDA Issues Statement on Makena March 30, 2011


• La FDA alertan a los consumidores para que dejen de usar la solución vitamínica Soladek March 28, 2011


• FDA Warns Consumers to Stop Using Soladek Vitamin Solution March 28, 2011


• FDA approves new treatment for a type of late-stage skin cancer March 25, 2011


• FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age March 24, 2011


• FDA: Michigan heart-lung bypass machine manufacturer enters into consent decree March 22, 2011


• FDA, EMA announce pilot for parallel assessment of Quality by Design applications March 16, 2011


• FDA approves imaging agent for central nervous system scans March 15, 2011


• Maryland sprout processor enters into consent decree with the FDA March 14, 2011


• FDA, Justice Department take action against McNeil-PPC Inc. March 10, 2011


• FDA approves device to maintain blood flow during artery bypass brain surgery March 10, 2011


• FDA approves Benlysta to treat lupus March 09, 2011


• FDA: E. coli O157:H7 cases linked to hazelnuts March 05, 2011


• FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis March 04, 2011


• FDA: Risk of oral birth defects in children born to mothers taking topiramate March 04, 2011


• FDA prompts removal of unapproved drugs from market March 02, 2011


• FDA approves new drug to treat chronic obstructive pulmonary disease March 01, 2011

• FOOD CO. Recalls Product Due To Possible Health Risk March 2, 2011


• Garden of Life, LLC. Issues a Voluntary Recall of Vitamin Code Raw Vitamin C Dietary Supplement March 2, 2011


• Teavana Corporation Voluntarily Recalls Peppermint Organic Herbal Tea Because of Possible Health Risk March 3, 2011


• DeFranco and Sons Recalls Hazelnuts and Mixed Nuts with Hazelnuts Due to Possible Health Risk March 3, 2011


• McCormick & Company Recalls Golden Dipt® Tempura Seafood Batter Mix Due To Unlabeled Milk Ingredient March 4, 2011


• Faribault Foods Announces Voluntary Recall of Field Day Organic Garbanzo Beans Due to Mislabeling and Undeclared Allergens March 4, 2011


• Unilever Announces Recall of Skippy® Reduced Fat Peanut Butter Spread Due to Possible Health Risk Limited Recall of 6 Best-If-Used-By Dates March 4, 2011


• OTC DRUG Nationwide Recall--Important Information for Patients About IV PREP Antiseptic Wipes March 5, 2011


• REMEDYTEAS Voluntarily Recalls Peppermint Organic Herbal Tea And Organic Herbal Tea Blend Because Of Possible Health Risk March 8, 2011


• Jones Natural Chews Co Recalls Pig Ear Dog Chews Because Of Possible Salmonella Health Risk March 8, 2011


• Vitalabs, Inc. Issues Voluntary Recall for Specific Lots of Whey Protein Isolate March 11, 2011


• PIERRE FOODS Voluntarily Recalls 320 Cases Of PierreTM pb jamwich, LOT 0068035 From Giant-Carlisle Stores IN MD, PA, VA AND WV March 11, 2011


• Oak Farms Dairy in Waco Conducts Voluntary Limited Recall of Half Gallon Plastic Bottles of Whole Chocolate Milk, Half Pint Paper Cartons of Whole Chocolate Milk, and Half Pint Paper Cartons of 1% Chocolate Milk Due to Presence of Alkaline Phosphatase in Samples March , 2011


• ONE World Enterprises Recalls O.N.E. Coconut Water Due To Mold March 11, 2011


• D&M Smoked Fish, Inc. Issues an Alert on Uneviscerated Shmaltz Herring and Cold Smoked Sprats March 14, 2011


• American Regent Initiates Voluntary Nationwide Recall of Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials March 15, 2011


• American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4% 30 mL Single Dose Vials and 100 mL Pharmacy Bulk Packs March 15, 2011


• H&P Industries, Inc. Issues a Voluntary Nationwide Recall of All Lots of Povidine Iodine Prep Pads Due to Potential Microbial Contamination March 15, 2011


• Shaping Beauty, Inc. Issues a Voluntary Nationwide Recall of Weight Loss Tea Found to Contain an Undeclared Drug Ingredient March 15, 2011


• American Regent Initiates Voluntary Nationwide Recall of Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials March 16, 2011


• Universal Nutrition Voluntarily Recalling Several Protein-Based Supplements Due To Possible Salmonella Contamination March 17, 2011


• Lilly Announces Important Action Regarding Recall of Alcohol Prep Pads Made by Triad Group Included in Forteo Starter Kits This Recall Does Not Affect or Involve Forteo Delivery Device March 17, 2011


• World Variety Produce, Inc. Recalls Serrano Peppers Because of Possible Health Risk March 18, 2011


• Thomas Produce Recalls Jalapeno Peppers Because of Possible Health Risk March 18, 2011


• Lakeside Foods Issues Recall of Nationwide Pickled Sliced Beets March 21, 2011


• Millar Instruments, Inc. Issues a Recall of Millar Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F March 21, 2011


• Del Monte Fresh Produce Voluntarily Recalls Cantaloupes Because Of Possible Health Risk March 22, 2011


• USA Far Ocean Group, Inc. Issues Voluntary Nationwide Recall of U-Prosta, a Product Marketed As a Dietary Supplement That Contains Undeclared Terazosin Hydrochloride March 22, 2011


• Seoul Shik Poom Inc. Issues Allergy Alert On Undeclared Egg In (Samlip) Red Bean Bread. March 22, 2011


• Recall of Arnica Flower And Stem Arnica Due To Inaccurate Usage Information On Product Label March 22, 2011


• Sassy Cow Creamery, LLC Issues Allergy Alert On Peanut Oil In Butter Pecan Ice Cream And Egg And Soy In Blueberry Cheesecake Ice Cream March 23, 2011


• Unified Grocers Issues Allergy Alert on Undeclared Milk in Cottage Hearth Stone Ground Wheat Bread (24 oz) and 7 Select 100% Whole Wheat Bread (24 oz) March 23, 2011


• Mai's Bakery Issues Allergy Alert For Undeclared Eggs in Their Packages of "Hopia Mongo" and "Moon Cake" Products March 24, 2011


• Candy Dynamics Recalls Toxic Waste® Short Circuits™ Bubble Gum Net wt. 3.2 oz. (90g) Package --- Lot # 15070SC12 March 25, 2011


• USA Far Ocean Group Inc. Issues Voluntary Nationwide Recall of X-Hero and Male Enhancer, Products Marketed as Dietary Supplements March 25, 2011


• APP Pharmaceuticals Issues A Nationwide Voluntary Recall Of Irinotecan Hydrochloride Injection March 25, 2011


• Greenstone Announces Voluntary Nationwide Recall Of Citalopram And Finasteride Due to Possible Mislabeling March 26, 2011


• CDC And ADPH Investigate Outbreak At Alabama Hospitals; Products Recalled March 29, 2011


• The Smokehouse LLC Recalls One Batch Of Portier Fine Foods Norwegian Smoked Salmon Because Of Possible Health Risk March 29, 2011


• Nutrition Express Voluntarily Recalls Protein Supplements Because Of Possible Health Risk March 29, 2011


• Louie Foods International Voluntarily Recalls Certain Sprouts Because of Possible Health Risk March 30, 2011


• Frankly Fresh Inc. Voluntarily Recalls Seafood Salad Products Because Of Possible Health Risk March 30, 2011


• Arko Foods International Recalls Angelina Brand Smoked Roundscad Because Of Possible Health Risk March 31, 2011

• March 30, 2011
• March 23, 2011
• March 16, 2011
• March 09, 2011
• March 02, 2011

• Food
• Drugs
• Medical Devices
• Tobacco Products
• Biologics
• Animal Feed and Drugs
• Radiation Protection
• Cosmetic
• Toxicological Research
• Regulatory Affairs

Return to the Top of the Newsletter

EAS in Action

Betty Campbell Provides Menu Labeling Update for FDLI Journal

EAS Vice President Elizabeth (Betty) Campbell provided an update on menu labeling for the March/April issue of the Food and Drug Law Institute’s Update Magazine, in which she reviewed the status of the chain restaurant labeling menu requirements introduced early last year.

On January 25, 2011, partly in response to unfavorable comments from interested parties, FDA withdrew draft guidance on implementation of the provision and said it would complete notice-and-comment rulemaking before beginning enforcement activities. The agency said this approach will “minimize uncertainty and confusion.”

The agency released two proposed regulations on April 1: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments, which would exempt movie theaters, airplanes, bowling alleys, and other establishments whose primary purpose is not to sell food from the menu labeling requirements; and a companion rule titled Calorie Labeling of Articles of Food in Vending Machines.

Food Labeling Seminar Participants Went Away Happy

Participants in the Food Labeling Compliance Review Seminar at the EAS headquarters in Alexandria, Va., March 29-30, heard an up-to-the-minute analysis of FDA labeling policy by EAS Vice President Elizabeth (Betty) Campbell, who served as head of FDA's Office of Food Labeling during the development of key labeling regulations.

EAS consultants James E. Hoadley, and Gisela Leon were the instructors for the hands-on seminar covered the basics of compliance with complex labeling rules, including labeling issues that have drawn warning letters from FDA. The program included practical work sessions that allowed participants to discuss specific labeling concerns.

This informative seminar, which is offered several times per year, is designed for individuals involved in management, regulatory affairs, and quality assurance in the manufacturing of foods, including those responsible for preparing or reviewing food labels. It is also popular with consultants, auditors, attorneys and others interested in food labeling compliance.

Seats Available for EAS Dietary Supplement GMP Seminar

It is not too late to sign up for the EAS Dietary Supplement GMP Seminars, which will be held April 12-13, 2011 at the EAS training facility in Alexandria, Va.

Expert instructors for this event include EAS Vice President Dean Cirotta, whose industry experience complements the FDA regulatory experience of his fellow instructor, EAS Senior Consultant William Ment, a former Director in FDA's Baltimore District Laboratory.

This in-depth program details the steps needed to achieve compliance with the Food and Drug Administration’s final GMP rule, covering the responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements.

Click here for more details, or contact Cathryn Sacra at 703-684-4438 or csacra@easconsultinggroup.com.

Mark Your Calendar for the Next Dietary Supplement Labeling Compliance Review Seminar

The next EAS Dietary Supplement Labeling Compliance Review Seminar will be held June 1-2, 2011, at the at the EAS headquarters in Alexandria, Va.

This in-depth seminar will provide all that is needed to prepare labels that comply with FDA requirements, including the mandatory labeling elements and allowable dietary supplement claims.

The program provides an opportunity to learn the specific details of FDA dietary supplement labeling requirements from regulatory experts, and to ask questions of former FDA officials.

Instructors for this program are EAS Senior Consultant James E. Hoadley, a former senior regulatory scientist at FDA; and EAS Consultant Gisela Leon, who has an extensive background in U.S., European and other international labeling requirements.

Click here to register, or contact Cathryn Sacra at 703-684-4438 or csacra@easconsultinggroup.com.

Visit EAS Exhibit Booth 1647 at Supply Side East

EAS Consulting Group will be exhibiting at the upcoming Supply Side East expo in Secaucus, N.J., May 3-4. If you plan to attend, please stop by and visit with EAS representatives Ed Steele, Chris Celeste and Norma Skolnik.

Return to the Top of the Newsletter

Upcoming Events

Dietary Supplement GMP Seminar
April 12-13, 2011
Alexandria, Va.

Supply Side East
May 2-4, 2011
Secaucus, N.J.

EAS Dietary Supplement Labeling Compliance Review Seminar
June 1-2, 2011
Alexandria, Va.

IFT Food Expo
June 11-14, 2001
New Orleans, La.

Return to the Top of the Newsletter

Order Publications and Regulatory Tools

	EAS Labeling Type Size Guide A handy tool for measuring type size, package dimensions and line width on food, dietary supplement, cosmetic and OTC drug labels.	$ 9.00
	Dietary Supplement GMP Regulation - A Pocket Guide A 4"x6" bound copy of 21 CFR Part 111 designed to fit in shirt pockets of management and plant personnel.	< 25 $ 10.00 each 25-50 $ 9.00 each 50-100 $ 8.00 each > 100 $ 7.00 each
	Pharmaceutical GMP Regulation - A Pocket Guide A 4"x6" bound copy of 21 CFR Part 210, 211 and 11 designed to fit in shirt pockets of management and plant personnel.	< 25 $ 10.00 each 25-50 $ 9.00 each 50-100 $ 8.00 each > 100 $ 7.00 each
	No Margin for Error – GMP Training Video A 1967 video produced by FDA demonstrating the consequences of not following GMPs. An excellent training tool to motivate employees to follow drug GMPs. 25 minute video in DVD format	$ 99.00
	Dietary Supplement Labeling Compliance Review, 3rd edition A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell Hardbound book	$ 194.99
	Food Labeling Compliance Review, 4th edition A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell. Hardbound book and CD	$ 229.00 / set
To purchase any items listed above download our

Return to the Top of the Newsletter