Issue of the Month
How Preambles Can Tell Us What FDA Was Thinking

Preambles to regulations often contain the information one needs to make regulatory compliance decisions. A client once asked if homeopathic OTC drug product labels must include the drug facts labeling required by 21 CFR 201.66. After searching the FDA website using many word combinations and scanning the Compliance Policy Guides (CPG) for drugs, I found the answer in the preamble to the Drug Facts regulation. In replying to a comment, the agency said there would be no express exemption for homeopathics and referred to CPG 7132.15 on “Conditions Under Which a Homeopathic Drug Product May Be Marketed" to address labeling for such products. That CPG does not specify a format; therefore, the company could choose either a traditional label layout or include the drug facts format with no risk.

Recently a client posed several questions about the combination of certain ingredients listed in the First Aid Antimicrobial Tentative Final Monograph (TFM). The issue became more complicated when the client decided to consider adding an active ingredient covered by the Skin Protectant Monograph, which is a final regulation. Questions then arose about whether Triclosan would be an acceptable ingredient, given that this ingredient is widely used in antibacterial soaps.

Although I had been quite familiar with the antimicrobial rulemakings by FDA, I had not worked with them for some time. To respond to the questions in an authoritative manner, I reviewed the preambles to six documents FDA had published in the Federal Register dating back to 1974. The skin protectant issues were relatively simple because the Final Regulation establishing the Monograph for this therapeutic category of OTCs was published in 2003 and it was clear on what antimicrobial/protectant combinations were allowed. However, the antimicrobial monographs are still not final and--particularly with respect to Triclosan-- they have followed a rather tortured path beginning with a 1974 Advanced Notice of Proposed Rulemaking, through a Tentative Final Order published in 1978.

The 1978 document included listings of active ingredients for Patient Preoperative Skin Preparations and Skin Wound Cleanser and reserved sections for Antimicrobial soap, Wound Protectants and Surgical Hand Scrubs. In 1991, FDA published a TFM for First Aid Antiseptic Products and in that rulemaking announced the restructuring of the Antimicrobial category. It discussed Alcohol and Diaper Rash products as separate sub-categories and stated that antimicrobial soaps with deodorant claims would be considered cosmetics. And it deferred action on antimicrobial soaps with drug claims to future rulemakings.

In 1994, a TFM for Healthcare Antiseptic Products was published, which set forth requirements for Healthcare Personnel Handwashes, Antiseptic Handwashes, Patient Preoperative Skin Preparations, and Surgical Hand Scrubs. Each of the earlier documents discussed the then-current status of Triclosan as an antimicrobial; however, the agency could not render a final decision even though FDA had received some data in response to stated concerns. Various groups continued to argue that Triclosan was an insult to the environment and could foster mutant, antibiotic resistant microorganisms. To complicate matters further, the 1994 document stated that the designation "antimicrobial soap" would no longer be considered for inclusion in the monograph and the sub-category into which Triclosan seemed to best fit was gone.

Notwithstanding that there were then and now hundreds of antibacterial or antimicrobial soaps with drug facts labeling on the market (most containing Triclosan) Triclosan has still not been deemed safe and effective in any of the TFM's or Final Monographs that have been published. About a year ago, FDA published a consumer update which said the agency was engaged in an ongoing review of Triclosan, that it did not have sufficient safety evidence to recommend changing consumer use of products containing Triclosan, and that it expected to communicate its findings in spring 2011. I had to inform my client that there would be a regulatory risk if Triclosan were used in a new product.

As these examples show, it is always a good idea to read the preambles to final regulations, because they set out to explain the agency’s thinking. Every final regulation deals with public comments received during the rulemaking process and those discussions provide a good insight into the agency’s views. The preamble to the final rule published in the Federal Register can be an invaluable source of information for answering those difficult compliance questions.

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FSMA Perspective
FDA Issues First Rules Under Food Safety Modernization Act

The Food and Drug Administration last month issued the first new rules in its implementation of the Food Safety Modernization Act – two interim final rules that will go into effect on July 3. Because of the very tight FSMA schedule, we can expect to see many new rules implemented through interim final rules—using this faster version of the full notice and comment rulemaking procedure.

One rule, titled the Interim Final Rule on Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption, allows the agency to detain for up to 30 days any food it believes has been produced under insanitary or unsafe conditions. Previously, the agency could only detain food if it had “credible evidence” that a food product presented was contaminated or mislabeled in a way that presented a threat of serious adverse health consequences or death to humans or animals.

The detained products will be kept out of the marketplace while the agency considers whether an enforcement action such as seizure or federal injunction against distribution of the product in commerce, is necessary.

Prior to the new rule, the agency typically worked with state agencies to embargo a food product under the state’s legal authority until federal enforcement action could be initiated in federal court.

FDA Deputy Commissioner for Foods Mike Taylor described the new rule as “a prime example” of how the new food safety law allows FDA to build prevention into the food safety system.

The second rule, titled the Interim Final Rule on Information Required in Prior Notice of Imported Food requires anyone importing food into the United States to tell the agency if any country has refused entry to the same product, including food for animals. The new reporting requirement will be administered through FDA’s prior notice system for imported food, which was established under the Bioterrorism Act of 2002.

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Who's Who at EAS
Meet EAS Senior Consultant, William L. Schwemer

William L. (Bill) Schwemer’s 30-year FDA career began in 1962 as a humble staffer in the agency’s Detroit District office and included service as Assistant Associate Commissioner for Regulatory Affairs.

After retiring from the agency in 1993, he joined AAC Consulting Group/Kendle as a senior consultant, where he advised domestic and international clients on FDA matters relating to pharmaceuticals, non-prescription drugs, dietary supplements and cosmetics.

In 2003, he became vice president of quality assurance and regulatory affairs at a contract manufacturer of personal care items including non-prescription drugs. In that role, he had responsibility for quality assurance, laboratory operations, and regulatory matters including compliance with FDA, safety and environmental rules. He developed an ISO based quality system that incorporated GMPs for pharmaceuticals.

Mr. Schwemer has been an expert witness in lawsuits involving civil disputes related to foods, drugs, medical devices and biologics and has testified at depositions and jury trials. He co-authored the Application of Pharmaceutical GMPs published by the Food and Drug Law Institute in 1997.

“Bill is a key member of our senior consulting team and I am delighted that our clients have access to his expertise,” says EAS President Ed Steele.

Thomas R. Campbell Joins EAS Consulting Team

Thomas R. Campbell is the newest addition to the EAS senior consulting team. His career has included work with some of the biggest names in the pharmaceuticals business, including Schering-Plough, Yamanouchi, Eli-Lilly, Wyeth-Ayerst, Merck, Abbott Laboratories and Sandoz, among many others. He has more than 20 years experience in pharmaceutical and biotechnology plant design and validation, including GMP compliance.

As a senior regulatory consultant with Kendle International, he provided a broad range of regulatory services including site audits. A former U.S. Navy officer, he holds a Master’s degree in electronics engineering from the U.S. Naval Postgraduate School.

“Tom’s extensive experience in many different manufacturing settings will be very helpful for our clients,” says EAS President Ed Steele. “I am very pleased to welcome him to our senior consulting team.”

Intern Dave Rejoins EAS

Parth K. Dave has rejoined EAS as a full-time employee based in our Rockville, Md., office. Parth spent last summer as an intern at the EAS headquarters in Alexandria, Va. He holds a Bachelor of Science degree in biological science from the University of Windsor and is currently completing the requirements for a Master’s degree in food safety and a certificate in international food law and regulations.

“I am very pleased to welcome Parth back to EAS. He has shown a strong commitment to our regulatory work and I believe he has a promising career ahead of him,” says EAS President Ed Steele.

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What's New on FDA's Website
May Updates

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

• FDA approves injectable gel to treat fecal incontinence May 27, 2011


• FDA approves treatment for Clostridium difficile infection May 27, 2011


• FDA seeks comment on preventive controls against foodborne illness May 26, 2011


• FDA to make enforcement and compliance activities accessible online May 26, 2011


• FDA takes action against illegal marketing of tobacco products May 25, 2011


• FDA approves Incivek for hepatitis C May 23, 2011


• FDA: Do not feed SimplyThick to premature infants May 20, 2011


• FDA approves Sutent for rare type of pancreatic cancer May 20, 2011


• United States requests seizure of adulterated cheese products at Wisconsin company May 20, 2011


• FDA clears first test to diagnose Q fever in military serving overseas May 20, 2011


• FDA approves new HIV treatment May 20, 2011


• FDA clears first test for recent infection with toxoplasmosis parasite May 19, 2011


• FDA: No compre medicamentos comercializados como suplementos nutricionales antimicrobianos May 13, 2011


• FDA: Don’t buy drugs marketed as antimicrobial dietary supplements May 13, 2011


• FDA warns about counterfeit ExtenZe dietary supplements May 13, 2011


• FDA approves Victrelis for Hepatitis C May 13, 2011


• FDA seeks permanent injunction against Tennessee food warehouses, owner May 11, 2011


• Consumers warned to avoid eating oysters from area 1642 in Apalachicola Bay, Florida May 10, 2011


• FDA requests input on development of user fee program for biosimilar and interchangeable biological products May 09, 2011


• FDA clears first test to quickly diagnose and distinguish MRSA and MSSA May 06, 2011


• FDA expands approved use for carotid stent May 06, 2011


• FDA approves new treatment for rare type of pancreatic cancer May 06, 2011


• FDA issues final guidance for liquid OTC drug products with dispensing devices May 04, 2011


• FDA issues first new rules under Food Safety Modernization Act May 04, 2011


• FDA, FTC act to remove fraudulent STD products from the market May 03, 2011


• FDA approves new treatment for Type 2 diabetes May 02, 2011

• Primal Pet Foods Issues Nationwide Voluntary Recall On Feline Chicken & Salmon Formula With A "Best By" Date Code Of 043112-17 May 30, 2011


• Transpecos Foods, LP Issues Allergy Alert On Undeclared Milk And/Or Egg Allergen In Onion Ring Product May 27, 2011


• BCS International Corp. Issues Allergy Alert On Undeclared Peanuts In Dr. Snack Choco Raisin With Sell By Date 03/05/2012 May 25, 2011


• Undeclared Eggs in “Halal Plain” & “Halal Fruit Cake” May 23, 2011


• Atalanta Corp. Recalls “Nazareth Classic and Nazareth Light Cheeses” Because of Possible Health Risk May 20, 2011


• Phoenix Import & Distribution Announces A Recall Of Pentrexyl Forte Natural May 20, 2011


• Schratter Foods Inc RECALLS “Quenby Hall Blue Stilton Cheese” BECAUSE OF POSSIBLE HEALTH RISK May 18, 2011


• Boss Pet Recalls Pig Ear Products Because of Possible Health Risk May 17, 2011


• BLACKMAN INDUSTRIES, INC. RECALLS PRIMETIME BRAND 2 CT., AND 5 CT. PREMIUM PIG EARS AND KC BEEFHIDE BRAND 20 CT. PREMIUM PIG EARS BECAUSE OF POSSIBLE SALMONELLA HEALTH RISK. May 17, 2011


• Nielsen-Massey Vanillas, Inc. Issues Voluntary Recall for Specific Lot of Madagascar Bourbon Pure Vanilla Bean Paste May 17, 2011


• CORRECTING and REPLACING Mann Packing Reissues and Expands Voluntary Recall of Party Trays and Snacks On The Go Items Containing Grape Tomatoes May 13, 2011


• Cinderella Sweets Issues Allergy Alert Passover Cookies with a Notation on the Packaging Stating “Egg Free” May 13, 2011


• Phoenix Import & Distribution Announces Recall Of Pentrexyl Forte Natural May 13, 2011


• Bimbo Bakeries USA, Inc. Announces Voluntary Regional Recall Of Entenmann’s Bagged Pop’ems Donuts And Bimbo 8 Pack Donitas Donuts Due To Off-Smell And Possible Mold Growth May 11, 2011


• Oberweis Dairy Issues Voluntary Allergen Alert on Undeclared Egg in Brownie Fudge Twirl Ice Cream Quarts May 11, 2011


• Mann Packing Reissues And Expands Voluntary Recall Of Party Trays And Snacks On The Go Items Containing Grape Tomatoes May 10, 2011


• Goodness Gardens, Inc. Recalls Chives Lot # 0201111 Because of Possible Health Risk May 10, 2011


• Doctor's CarbRite Diet Expands Allergy Alert on Certain Flavored Bars May 10, 2011


• Bottled Water Recall May 09, 2011


• Del Monte Fresh Produce N.A. Inc. Voluntarily Recalls Grape Tomatoes Grown by Six L’s Packing Due to Potential Health Risk May 09, 2011


• Multi-Mex Distributor Inc. Announces Recall of Dietary Supplements May 09, 2011


• Northeast Produce Inc. Recalls Grape Tomatoes Due to Salmonella Risk associated with Six L’s Packing Company Inc. in Immokalee, FL May 06, 2011


• Ralcorp Frozen Bakery Products Issues Voluntary Allergen Recall of Market Pantry May 06, 2011


• Flowers Foods Issues Voluntary Recall on Certain English Muffins and One Bread Item May 06, 2011


• Nut Bar Company Issues Allergy Alert On Undeclared Walnuts In GFS Pecan Pieces May 06, 2011


• TRI-STATE Baking Company, L.L.C. Issues Allergy Alert On Undeclared Soy Flour, Soy Lecithin, And/Or Milk In Product May 06, 2011


• American Regent Initiates Nationwide Voluntary Recall of Caffeine & Sodium Benzoate Injection, USP 250 mg/mL, 2 mL Single Dose Vial Due to Visible Particulates May 05, 2011


• Taylor Farms Pacific, Inc. Recalls Grape Tomatoes Due to Salmonella Risk May 05, 2011


• Safeway Recalls Kabobs Made with Grape Tomatoes in Several States May 05, 2011


• Mastronardi Produce Voluntarily Recalls Grape Tomatoes Because of Possible Health Risk May 04, 2011


• Keys Manufacturing Company, Inc. Recalls Pig Ears for Pet Treats Because Of Possible Salmonella Health Risk May 04, 2011


• The Raymond-Hadley Corporation Expands Allergy Alert On Undeclared Milk In Better Batter Mixes To Include One Lot Of #1 Gluten Free Brand Chocolate Cake Mix And #1 Gluten Free Brand White Cake Mix May 03, 2011


• Porky Products Inc. Recalls Salted Smoked Herring (Bloaters) May 03, 2011

• May 03, 2010 Sacred Obligation: Restoring Veteran Trust and Patient Safety
  Anthony D. Watson, B.S., M.S., M.B.A., before the House Committee on Veterans' Affairs

• May 25, 2011
• May 18, 2011
• May 11, 2011
• May 04, 2011

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

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EAS in Action

Dean Cirotta Shares GMP Guidance with Participants at Tobacco Conference

EAS Vice President Dean Cirotta reviewed FDA’s current Good Manufacturing Practices regulations at a pre-conference session at the Tobacco Merchants Association’s 96th annual meeting and conference in Williamsburg, Va., May 22-24. Participants found his side-by-side comparison of the food, dietary supplement, pharmaceutical and medical device GMPs particularly helpful as they discussed drafting and proposing GMPs for the tobacco industry.

This year’s event was titled "Evidence-based Science and Regulation of the Tobacco Industry." In addition to an impressive array of industry experts, the program included senior management staff from the FDA Center for Tobacco Products. The agency is increasing its compliance efforts for tobacco products. It recently issued eleven warning letters for misleading or unsubstantiated claims or descriptors indicating that products can be used to reduce harm or the risk of tobacco-related disease. EAS experts are available to help the industry in its compliance efforts.

EAS Exhibits at SupplySide East

More than 3,000 food and beverage, cosmetic and personal care, and dietary supplement executives from 30 countries attended the 13th annual SupplySide East, held May 2 to 4 at the Meadowlands Exposition Center in Secaucus, N.J.

The sold-out exhibit hall included an EAS booth, at which President Ed Steele, Director of Regulatory Information and Submissions Chris Celeste, and Senior Consultant Norma Skolnik, discussed the regulatory needs of participants.

EAS Presents Up-to-Date Information at Dietary Supplement Labeling Compliance Review Seminar

Participants at the EAS Dietary Supplement Labeling Compliance Review seminar at the EAS Training Facility in Alexandria, Va. June 1-2, got an insight into how the FDA thinks about labeling issues and heard the latest regulatory developments in this fast-evolving area. The in-depth seminar covered mandatory labeling requirements and for compliant labels, and allowable claims for dietary supplements.

The instructors for this popular program were 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.

EAS Schedules Fall Food Labeling and Dietary Supplement GMP Seminars

It’s not too early to plan your staff training schedule for the fall. The next EAS Food Labeling Compliance Review seminar will be held at the EAS Consulting Group Training Facility, 1940 Duke Street, Suite 200, Alexandria, VA., on November 8-9, 2011. This is a seminar for anyone who needs to understand FDA’s latest thinking on food labeling requirements. It includes practical work sessions in which participants can get their specific labeling issues addressed by labeling experts who helped develop and implement the current regulations.

The next Dietary Supplement GMP Seminar will be held November 15-16, 2011. Participants in this intensive training program will receive all the information needed to comply with the GMP rule. The seminar covers 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.

EAS Participates in June Food and Drug Trade Shows: IFT in New Orleans; ISPE in Washington, D.C.

EAS will be exhibiting at the upcoming Institute of Food Technologists Food Expo in New Orleans, June 11-14, and at the International Society for Pharmaceutical Engineering 2011 Washington Conference, in Washington, D.C., June 6-11.

At the IFT Food Expo, join EAS Consulting Group President Ed Steele and Vice President Betty Campbell at exhibit booth 7154. At ISPE 2011, join Senior Advisor Tony Celeste and EAS Director of Regulatory Information and Submissions, Chris Celeste, at exhibit table 41.

We look forward to seeing you there!

EAS President Ed Steele Attends IFT Congressional Support for Science Award Ceremony

EAS President Ed Steele attended the Institute of Food Technologists’ 2011 Congressional Support for Science Award ceremony on Capitol Hill, May 25. This year’s award went to Sen. Herb Kohl (D-Wis.)—pictured left— and Sen. Pat Roberts (R-Kan.).

The Food Safety Modernization Act includes a provision championed by Kohl that allows the FDA to refuse imported food from a foreign facility that does not allow U.S. inspectors into the country to inspect a facility within 48 hours of a request to enter. In addition, he introduced the Food Safety Accountability Act that would increase penalties for intentional actions aimed at jeopardizing the U.S. food supply.

Kohl chairs the Senate Agriculture Appropriations Subcommittee which has jurisdiction over the Food and Drug Administration and the USDA Food Safety and Inspection Service. He worked closely with both FDA and USDA on their efforts to keep the food supply safe. He pushed the FDA to increase the number of food safety inspectors domestically and abroad, and to develop new, regional rapid response teams across the country to identify and isolate contaminated produce at its source.

Sen. Roberts also supported the FSMA and he played a leading role in the approval and construction of the National Bio and Agro-Defense Facility in Manhattan, Kan.

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Upcoming Events

International Society for Pharmaceutical Engineering (ISPE) 2011 Washington Conference
June 6-11, 2011
Washington D.C.

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

EXPO East
Sept. 21-24, 2011
Baltimore, Md

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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

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