Issue of the Month
FDA Targets Certain Classes of Dietary Supplements for Enforcement Action

The Food and Drug Administration is targeting certain tainted dietary supplement products for enforcement action, in response to numerous serious adverse events reported to the agency’s MedWatch system. A majority of the serious adverse events being reported are associated with bodybuilding, weight loss, or sexual enhancement products.

From the agency’s perspective, the “tainted” dietary supplement products include those that contain approved prescription drug ingredients, banned drug ingredients, drug analogs, controlled substances such as anabolic steroids, or novel synthetic steroids that do not qualify as dietary ingredients.

The agency has singled out synthetic steroids and steroid-like supplement ingredients as one category of ingredients likely to have inadequate information to provide reasonable assurance that they do not present a significant or unreasonable risk. Proving a specific dietary supplement product is unsafe is a complicated and time-consuming task for FDA. Instead, FDA’s enforcement approach has been to assert that synthetic steroid substances generally do not qualify as dietary ingredients and thus synthetic steroid containing products are unapproved new drug rather than dietary supplements. Also, FDA has asserted supplement manufacturers would be marketing adulterated supplements when other dietary ingredients are used in a supplement without a New Dietary Ingredient (NDI) Notification having been submitted to FDA.

A common practice in the supplement industry is to interpret the Food, Drug and Cosmetic Act definition of dietary supplement to mean that synthetic copies of metabolites and constituents of a dietary substance qualify as dietary ingredients (“dietary ingredient” is regulatory jargon for the active ingredients in supplements). FDA has a different interpretation as to what is eligible to be a dietary ingredient. FDA believes that substances, which qualify as dietary ingredients because they are a constituent of another dietary ingredient, are only dietary ingredients if they have been extracted and purified from the parent material. FDA believes that synthetic versions of otherwise eligible steroids are not dietary ingredients unless the synthetic version itself is a dietary substance because it has a history of use as a food ingredient.

Another difference between the supplement industry and FDA in interpretation of the Dietary Supplement Health and Education Act is for the 75-day NDI Notification requirement exclusion. The exclusion applies to dietary ingredients “which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.” Failure to submit a NDI Notification when required causes a dietary supplement to be deemed adulterated. The supplement industry generally takes a more expansive view of the NDI Notification exclusion provision than does the FDA.

The 2011 Food Safety Modernization Act instructs FDA to publish New Dietary Ingredient guidance to clarify (1) when a dietary ingredient is a new dietary ingredient, (2) when the manufacturer of a dietary supplement should submit a New Dietary Ingredient Notification to FDA, (3) the evidence needed to document the safety of new dietary ingredients, and (4) appropriate methods for establishing the identity of a new dietary ingredient. The FDA New Dietary Ingredient Guidance is expected to be issued late this coming summer and is likely to be controversial within the supplement industry.

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FSMA Perspective
FDA Streamlines Rulemaking for FSMA Implementation

Food and Drug Administration officials are hoping to issue a final rule on preventive controls by the end of this year as part of FDA’s implementation of the Food Safety Modernization Act.

The agency has streamlined its regulatory review process by forming work groups made up of representatives of the various offices that review rules in the pipeline, so the required reviews for FSMA-related rulemaking will now take place simultaneously.

The agency invited comments from stakeholders in an April 20 public meeting at which FDA officials posed questions to the regulated community about the implementation of FSMA provisions on preventive controls. The meeting included five breakout sessions, each of which was repeated three times in the course of the day. This allowed participants to attend up to three sessions in smaller groups. But it also meant that the content of the sessions varied each time, because they drew different participants and different responses to the questions from agency officials.

In one breakout session on product testing and environmental monitoring, participants heard that the agency is considering mandatory environmental testing as part of its FSMA implementation efforts. In addition, it is likely that current Good Manufacturing Practice regulations will be revised to require elements that are currently only recommended best practices.

In a breakout session on preventive controls for food and feed facilities, Jean Halloran, director of food policy initiatives at Consumers Union, urged the agency to require product testing for pathogens as part of the verification component of preventive controls. But John Allen, manager of regulatory and international affairs at the American Frozen Food Institute, said the group believes the agency should not require finished product testing and that it should avoid setting prescriptive regulations. AFFI expects to publish its own revised cGMPs soon, he said.

In a session on environmental monitoring, a representative of one company working with dry flour products said the firm used environmental sampling for indicator organisms and only used product testing for verification rather than as a preventive control.

Another breakout session focused on what guidance the agency should issue as it implements the FSMA (the acronym is now pronounced “fizz-ma” by agency officials). This session was moderated by Jenny Scott, former vice president of food safety programs for the Grocery Manufacturers Association, who is now an FDA staffer and is leading the agency’s work group on guidance for preventive controls. The Food Allergy and Anaphylaxis Network wants the agency to issue specific guidance on allergens and to require an allergen control plan as part of its new requirements for preventive controls.

Scott told participants that the agency does not want to reinvent the wheel in setting standards and that it expects to make use of existing science-based standards whenever possible.

Benjamin Miller, who is operations and response section manager for the Minnesota Department of Agriculture’s dairy and food inspection division, expressed concerns about the burden that FSMA implementation will place on states. State officials conduct inspections under a contract with the federal authority. The state also conducts environmental sampling of high-risk facilities under a federal contract. Implementation of FSMA will put an additional strain on state budgets, he said.

FDA has opened a docket (FDA-2011-N-0251) specifically for preventive controls and is inviting public comments by May 20.

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Who's Who at EAS
Meet EAS Senior Advisor Anthony C. Celeste

Anthony C. Celeste joined EAS in January 2011 as Senior Advisor--a special role at EAS that acknowledges his outstanding status in the regulatory arena for all FDA-regulated product areas, particularly those involving pharmaceuticals.

Mr. Celeste began his 25-year FDA career as a chemist in the New York District Office and progressed to become director of the Office of Regional Operations in Washington, D.C. It that role, he directed the agency's field force of investigators, analysts, compliance officers, and administrative staff.

After he retired from the agency in 1985, he joined AAC Consulting Group as president and CEO. He served in that role until AAC was acquired in February 2001 by Kendle International Inc., a global clinical research organization. He retired in January 2010 as Kendle’s senior vice president of regulatory affairs.

Mr. Celeste is not only playing a advisory role at EAS, he is also available to provide expert consulting to our clients who needs the benefit of his years of regulatory experience.

“Tony is one of the most prominent experts in our industry and I am delighted to have him with us in an advisory role,” says EAS President Ed Steele.

Former FDA Director of Field Sciences Joins EAS Consulting Team

Michael C. Olson, former director of FDA’s Division of Field Sciences and chief scientist for the Office of Regulatory Affairs, has joined EAS as a senior consultant. In his 35-year career with the agency, he first served as a bench chemist and later advanced to management roles in the Centers for foods, drugs and medical devices.

Mr. Olson has extensive experience in operations and policy for food and drug regulatory laboratories. As director of Field Sciences, he oversaw the operations of thirteen field laboratories and three research centers. During his tenure, ORA’s laboratories developed a program to become accredited to ISO 17025, and the laboratory policy and operations manual was completely revamped.

“I am delighted to welcome Mike to our consulting team,” says EAS President Ed Steele. “With his depth of knowledge, he will be an important asset for clients who need regulatory guidance for their laboratory operations for foods, pharmaceuticals, medical devices and other FDA-regulated products.”

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What's New on FDA's Website
April Updates

Listed below are links to new additions to the FDA website for the month of April, 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 looks to improve design and cleaning instructions for reusable medical devices April 29, 2011


• FDA approves Zytiga for late-stage prostate cancer April 28, 2011


• FDA requests seizure of adulterated breaded seafood at Wisconsin firms April 28, 2011


• FDA seeks permanent injunction against Pennsylvania dairy April 26, 2011


• FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers April 22, 2011


• FDA warns companies to stop making MRSA claims for over-the-counter products April 20, 2011


• FDA 'Strategic Priorities 2011 - 2015' now available April 20, 2011


• FDA approves Rituxan to treat two rare disorders April 19, 2011


• FDA approves new medical device for form of brain cancer April 15, 2011


• FDA approves Actemra to treat rare form of juvenile arthritis April 15, 2011


• FDA approves new treatment for large brain aneurysms April 13, 2011


• FDA permits marketing of first test to help diagnose dengue fever April 08, 2011


• FDA clears single-use antibacterial surgical respirator April 08, 2011


• FDA clears test for bacteria that can cause serious intestinal disease April 08, 2011


• FDA approves Horizant to treat restless legs syndrome April 07, 2011


• FDA approves new treatment for rare form of thyroid cancer April 06, 2011


• FDA approves new device to treat brain aneurysms April 06, 2011


• FDA acts to prevent contamination problems with Triad antiseptic products April 06, 2011


• FDA launches consumer-friendly Web search for consumers during recalls April 04, 2011


• FDA proposes draft menu and vending machine labeling requirements, invites public to comment on proposals April 01, 2011

• Six L's Voluntarily Recalls Grape Tomatoes Because of Possible Health Risk April 29, 2011


• Defibtech Announces a Voluntary Recall of DDU-100 series AEDs April 29, 2011


• Taylor Farms Pacific, Inc. Recalls Grape Tomatoes Due to Salmonella April 29, 2011


• Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin (Warfarin Sodium) Crystalline 5 mg Tablets, Lot Number 9H49374A April 29, 2011


• Simply Asia Foods, LLC Recalls Three Flavors of Thai Kitchen Rice Noodle Carts and One Flavor of Simply Asia Noodle Bowl Due to Undeclared Milk Ingredient April 29, 2011


• Quinault Tribal Enterprise Recalls All Canned Seafood Products Because of Possible Health Risk April 29, 2011


• Organic Food Bar, Inc. Expands its Voluntary Recall on Chocolatey Chocolate Chip Bars to Include Additional Products and Lots April 29, 2011


• Satur Farms, LLC Recalls Satur Farms Cilantro Because Of Possible Health Risk April 29, 2011


• Ethos Environmental, Inc. Issues a Voluntary Recall of Specific Lots Of The Dietary Supplement Regenerect April 29, 2011


• American Regent Initiates Voluntary Nationwide Recall of Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial Due to the Presence of Particulate Matter April 26, 2011


• The Raymond-Hadley Corporation Issues Allergy Alert on Undeclared Milk in Better Batter Brand 20oz. & 2.5lb. Pancake & Biscuit Mix, 18.25oz. Yellow Cake Mix, and 18.25oz. Chocolate Cake Mix April 26, 2011


• Elise Grace's Dry Food Company Issues Nationwide Allergy Alert Because Of Undeclared Allergens In Their Dry Food Products Line April 26, 2011


• Important Information for Atwater Carey First Aid Kit Consumers Regarding Triad Group’s Povidone Iodine Prep Pads April 25, 2011


• Jonathans Sprouts Recalls Alfalfa Sprouts Because of Possible Health Risk Extends Recall of 4/19/11 to Additional Products and Codes ) April 24, 2011


• L&M Companies, Inc. Recalls One Lot of Whole Cucumbers Because of Possible Health Risk April 22, 2011


• Undeclared Milk in “Carob Brown Rice Crunch Squares” & “Carob Mint Miniatures” April 22, 2011


• Woodsmoke Provisions Voluntarily Recalls 160 packages of 4 oz. The Fresh Market Signature Collection Atlantic Smoked Salmon Due to Possible Health Risk April 22, 2011


• Doctor's CarbRite Diet Issues Allergy Alert on Certain Chocolate Brownie Flavored Bars April 21, 2011


• Satur Farms, LLC Recalls Satur Farms Cilantro Because of Possible Health Risk April 21, 2011


• S&M (USA) Enterprise Corp. Issues Alert on Undeclared Sulfites in Grove Grow Notes Dried Taro April 20, 2011


• S&M (USA) Enterprise Corp Issues Allergy Alerts on Undeclared Eggs In Rain Swiss Roll (Strawberry Flavor) and (Coconut Flavor) April 20, 2011


• See’s Candies, Inc. Issues Allergy Alert on 4.25 ounce Mayfair Eggs, Code 138 April 20, 2011


• Jonathans Sprouts Recalls Alfalfa Sprouts Because Of Possible Health Risk April 20, 2011


• TS&M (U.S.A.) Enterprise Corp Issues Allergy Alert On Undeclared Eggs In Rain Swiss Roll (Banana Flavor) April 20, 2011


• Charcuterie La Tour Effel Recalls Mousses And Dips April 18, 2011


• Royal Sweet Bakery, Inc. Issues an Alert on Uneviscerated Fish April 18, 2011


• A-1 Sandwich Company Voluntarily Recalls Sandwiches with Undeclared Allergens April 18, 2011


• La Fiesta Food Products, Inc., Issues Allergy Alert due to Incorrect Ingredient Label on Dried Shredded Shrimp April 15, 2011


• Organic Food Bar, Inc. Issues Allergy Alert on Chocolatey Chocolate Chip Raw Organic Food Bars April 15, 2011


• B&M, Inc. Conducts Voluntary Nationwide Recall Of 6 Lot Numbers Of Archer Farms Ground Turmeric Due To Excessive Lead Levels. April 15, 2011


• Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX® April 14, 2011


• Mexicantown Whole Issues Allergy Alert On Undeclared Pecans In Pan Nuez And Undeclared Milk In Magdalena, Pan De Maiz, YoyoPan Nuez, And Tacos De Pan Danes April 11, 2011


• Moog Recalls Curlin Ambulatory Infusion Pump Models 6000 CMS, 6000 CMS IOD, PainSmart, and PainSmart IOD April 11, 2011


• Waco’s Bestyett Sandwiches issues a Voluntary Recall of Pimento Cheese Sandwiches and Chicken Salad Sandwiches due to Undeclared Eggs April 08, 2011


• bioMérieux, Inc. Issues Urgent Expanded Product Recall for VITEK® 2 Piperacillin/Tazobactam Test on Gram Negative Susceptibility Cards April 08, 2011


• Tri-Union Seafoods Issues Precautionary, Voluntary Recall Of Limited 6.5-Ounce Chopped Clams April 08, 2011


• Le Bon Patissiere-2, Inc. Announces Voluntary Recall On Select Le Bon Patissiere Products That Contain Undeclared Allergens April 07, 2011


• Fresh Express Announces Precautionary Recall of a Limited Number of Cases of 9 oz. Bag Spinach Due to Possible Health Risk from Salmonella April 06, 2011


• AVNS, Inc. Issues a Voluntary Recall of THE BEST Enhancer April 04, 2011


• Cottage Grove Farmhouse Bakery Issues Allergy Alert On Undeclared Pasteurized Egg White In Breads April 01, 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 April , 2011


• Centurion Medical Products Initiates Voluntary Recall of Customized Convenience Kits (including select Central Venous Catheter, PICC Insertion, and VAD Trays) that contain American Regent’s Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials April 01, 2011


• Arko Foods International Recalls Angelina Brand Smoked Roundscad Because Of Possible Health Risk April 01, 2011

• April 13, 2010 A Delicate Balance: FDA and the Reform of the Medical Device Approval Process - William Maisel, M.D., M.P.H., before the Senate Special Committee on Aging
• April 13, 2010 Import Safety: Status of FDA's Screening Efforts at the Border - Margaret A. Hamburg, M.D., before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations

• April 27, 2011
• April 20, 2011
• April 13, 2011
• April 06, 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

EAS Conducts Dietary Supplement Labeling Compliance Review Seminar

FDA’s policies on dietary supplement labeling continue to evolve, so it may be time to refresh your knowledge and to learn the latest insights from our labeling experts. 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.

At this two-day seminar you will learn FDA dietary supplement labeling requirements from former FDA and industry labeling officials. You will be able to get an "insiders" perspective of how the agency thinks. The seminar will cover mandatory labeling requirements and will provide valuable guidance on how to make claims without crossing the "drug" line.

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

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.

EAS VP Betty Campbell Provides Insights on Antioxidants in Nutritional Outlook Magazine

EAS Vice President Elizabeth (Betty) Campbell offered her perspective on FDA’s enforcement of food and dietary supplement labeling violations, in the April issue of Nutritional Outlook Magazine.

The agency’s stricter approach to antioxidant claims, “indicates that manufacturers need to be more careful in the language they use on labeling and avoid making unauthorized implied nutrient content claims,” she said.

The agency issued at least three Warning Letters last year criticizing antioxidant claims for tea products. All three products made claims for antioxidants that used terms the agency had formally or informally designated as expressed or implied nutrient content claims. The claims included such terms as “enhanced with,” “packed with,” “fortified with,” “abundantly found in,” and “rich source.”

“We advise clients who want to make antioxidant claims to avoid the types of terms cited in these Warning Letters,” she said.

EAS Featured at FDLI Annual Conference

EAS Senior Consultant James Hoadley discussed the latest developments in labeling claims for dietary supplements, at the Food and Drug Law Institute’s Annual Conference in Washington, D.C., April 5-6, 2011. EAS Consulting Group was a sponsor as well as an exhibitor at this meeting, which is the longest-running event for food and drug law stakeholders. This year’s event assembled some 700 professionals from regulated industry, Congress and federal agencies.

Visit EAS Representatives at IFT Expo in New Orleans

EAS Consulting Group will be exhibiting at the upcoming IFT Food Expo in New Orleans, June 11-14, 2011. If you plan to attend, please join EAS representatives Ed Steele, Betty Campbell and Jim Hoadley at booth 7154. You can leave your business card for a chance to win an iPod.

EAS to Exhibit at ISPE Conference in Washington, D.C.

EAS will be among the exhibitors at the International Society for Pharmaceutical Engineering (ISPE) 2011 Washington Conference in Washington, D.C., June 6-11, 2011. Please joins us as at table 41to discuss your regulatory needs with Ed Steele, Tony Celeste and Chris Celeste. EAS has an outstanding staff of pharmaceutical consultants to assist you throughout the drug development process.

EAS to Showcase at Tobacco Conference

EAS will exhibit at the Tobacco Merchants Association’s 96th annual meeting and conference in Williamsburg, Va., May 22-24. This year’s event is titled "Evidence-based Science and Regulation of the Tobacco Industry." As the Food and Drug Administration implements its new regulatory authority for tobacco products, EAS is available to help the industry in its compliance efforts. EAS Vice President Dean Cirotta will be among the presenters at a May 22 pre-conference session on Good Manufacturing Practices and the FDA.

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Upcoming Events

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

Tobacco Merchants Association (TMA) annual meeting and conference
May 22-24, 2011
Williamsburg, Va.

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

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.

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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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