Issue of the Month
New FDA Requirements for Sunscreens

On June 14, FDA issued major new regulations for OTC sunscreen products that will have a great impact on SPF product labeling. Now that a final rule has been issued, FDA enforcement of sunscreen labeling regulations is expected to become stronger. The new regulations include the following:

• A final regulation that establishes standards for testing the effectiveness of sunscreen products and requires new labeling that accurately reflects test results. Additional labeling changes are also required (see below).
• A proposed regulation that would limit the maximum SPF value on sunscreen labeling to “SPF 50+”.
• A data request for safety and effectiveness information for sunscreen products formulated in certain dosage forms (e.g. sprays).
• A draft guidance for sunscreen manufacturers on how to test and label their products in light of these new regulations.

FDA’s final sunscreen regulation, which becomes effective in one year, establishes a standard test for OTC sunscreen products that will determine which products are allowed to be labeled as “Broad Spectrum.” Products that pass this test will provide protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA). Both UVB and UVA can cause sunburn, skin cancer, and premature skin aging. Under the new regulations, sunscreen products that protect against all types of sun-induced skin damage can be labeled “Broad Spectrum” and “SPF 15” or higher on the front (PDP) panel. These products will be allowed to claim not only that they protect against sun burn, but also that if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging. By contrast, any sunscreen that doesn’t meet the “Broad Spectrum” labeling requirements or that has an SPF value of less than 15 can only claim that it helps prevent sunburn.

The final regulation also includes these additional new labeling requirements:

1. Sunscreens products that aren’t broad spectrum or that have SPF values less than 15 will be labeled with a warning that says: “Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or skin aging.”
2. Water resistant claims on the product’s front label must tell how much time a user can expect to get the declared SPF protection level while swimming or sweating, based on standard testing. Two times will be permitted on labels: 40 minutes or 80 minutes.
3. Manufacturers can’t make claims that sunscreens are “waterproof” or “sweat proof” or identify their products as “sunblocks.” Also sunscreens can’t claim immediate protection on application (e.g. “instant protection”) or protection for more than 2 hours without reapplication unless they submit data and gain FDA approval.

FDA Proposed Regulations, Data Request & Draft Guidance:

In addition to the final rule, FDA is proposing a regulation that would require sunscreens with an SPF value higher than 50 to be labeled as “SPF 50+” since FDA doesn’t have adequate data demonstrating that products with SPF values above 50 provide additional protection compared to those with a 50 SPF value.

FDA is requesting data on certain dosage forms of sunscreen products in the form of an ANPR. For sunscreen spray products in particular, the agency requests additional data to establish effectiveness and to determine if there is a safety concern if a spray is inhaled unintentionally.

FDA is also issuing a draft guidance to help manufacturers understand how to label and test their products in light of the final and proposed regulations. Agency officials hope manufacturers will implement the new sunscreen rules before their effective date.

Impact on Industry:

New testing and labeling requirements will distinguish broad spectrum sunscreen and SPF 15 products from those that are less effective and don’t protect against skin cancer and early skin aging; this is a major change and one that will probably influence consumer purchasing choice. Another likely change is increased FDA enforcement action against sunscreen products that don’t comply with regulatory requirements.

Up until now, some sunscreen products and others bearing an SPF value haven’t always complied with OTC sunscreen monograph labeling requirements. Although sunscreens are OTC drugs and are required to be labeled with a Drug Facts box, some marketed SPF products haven’t complied with this requirement. Many marketed sunscreen products are also currently called “Sunblocks”, a term that is now no longer permitted by the new regulation.

FDA hopes companies will implement the new labeling requirements before their effective date in June 2012. Although the new regulations can’t be enforced until then, existing rules are likely to be enforced more aggressively and marketed sunscreen products may be subject to greater scrutiny.

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FDA Takes a Closer Look at Whole Grain Claims

On May 26, FDA signaled that it is gathering support for new regulations or guidance on whole grain claims by announcing that it is going to conduct a study of consumer responses to whole grain labeling statements on food packages. Although the agency previously issued guidance on what constitutes whole grain, it has not yet issued guidance on permissible claims and the amount of whole grain content required to support them.

FDA’s action was prompted by the proliferation of products with whole grain claims that were launched in response to a growing number of government recommendations to consumers — including in the Dietary Guidelines for Americans 2010 — to increase the amount of whole grains in the diet. The agency’s action may also have been influenced by a presentation I made in December 2010 –in my former role as Senior Staff Attorney for Legal Affairs with the Center for Science in the Public Interest. I described misleading whole grain claims to FDA compliance and labeling officials and provided them with numerous product examples. I listed several categories of misleading claims:

• Misuse of the term wheat—calling bread or crackers “wheat bread” or “wheat crackers” to suggest that the product is whole grain.
• Using the term “made with whole grain [or whole wheat]” when the product has minimal amounts of whole grain.
• Multigrain claims—when the product has minimal whole grain content.
• Stone ground claims—when the product has more refined grain than whole grain.

FDA says its survey will examine the following: (1) Consumer judgments about food products including nutritional attributes, overall healthfulness and health benefits; (2) Consumer judgments about a label’s credibility; (3) Perceived differences between statements such as “Made with whole grain,” “contains whole grain” and “whole grain;” (4) Halo effects, i.e., consumer extrapolation of whole grain statements beyond the scope of the statements themselves; and (5) How whole grain statements influence use of Nutrition Facts by consumers.

FDA is accepting public comments on the “Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages,” until July 25 (see EASeDocs-F017-11- 76 Fed. Reg. 30725. As the agency moves ahead with this review, I think it would be wise for companies to reevaluate their claims to ensure they are not deceptive.

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Sellers of Organic Cosmetics Sued in California

Thirty four companies that sell organic cosmetics in Alameda County, California, are named as defendants in a lawsuit filed June 16 in California’s Superior Court by an Oakland-based environmental advocacy group, the Center for Environmental Health (CEH). The suit claims the companies sell products that are labeled as organic, although the products do not contain 70 percent or more organic ingredients as required by the California Organic Products Act of 2003 (COPA).

Under COPA, cosmetics with less than 70 percent organically produced ingredients, may not be labeled as organic. Such products may only identify the organic ingredients in the ingredient statement or state the product's percentage of organic contents on the information panel. The percentage of organic material is determined by dividing the weight of the ingredients, excluding water and salt, by the total weight of the product, excluding water and salt.

The CEH complaint (available from EAS-e-Docs: EASeDocs-C002-11.pdf) cites numerous products that contain less than 70 percent organic ingredients and that fail to identify in the ingredient statement which ingredients were organically produced. Based on the defendants’ own ingredient lists, organic ingredients do not make up 70 percent or more of the products by weight or volume, CEH says.

These charges are based on alleged violations of the California state law. There is not a firm Federal position on organic claims on cosmetic labels. USDA has stated that cosmetics labeled as organic are not regulated under its National Organic Program unless the label or labeling implies that the product is USDA certified organic. FDA and FTC are collaborating on consumer studies regarding the impact on consumers of “organic” claims on cosmetics. These two agencies will focus on whether the claims are deceptive. Enforcement decisions would be made on a case-by-case basis.

EAS consultants are available to assist companies that wish to make organic claims on their cosmetic products. We can research individual state requirements and provide advice about the USDA Certified Organic claims as well as those claims that do not refer to the USDA certification.

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FSMA Perspective
FDA Seeks Input on Inspection and Compliance Issues

Registration of food establishments under the Food Safety Modernization Act will be identical to registration under the Bioterrorism Act of 2002, FDA officials explained at a June 6 public meeting on FDA’s implementation of the act’s inspection and compliance provisions. The meeting followed the format of previous FSMA meetings and included four breakout “listening sessions,” repeated three times.

In one session titled “Manner of Inspection in the Preventive Controls Environment,” moderated by Kathy Gombas, participants were asked about inspection approaches FDA could use to satisfy domestic and foreign inspection frequency mandates. One suggested approach was to require facilities to submit their preventive control plans to the agency, so they could be reviewed before an inspection, which would then take less time to complete. However, it is not clear that the FSMA gives the agency the authority to require prior submissions of preventive control plans.

One Canadian Food Inspection Agency official commented that mandatory recalls “incentivize compliance” even though it is rarely necessary to use such authority. The CFIA has had mandatory recall authority since 1998 but has only used it a dozen times, the official said.

American Frozen Food Institute representative John Allan, said that suspension of a facility’s registration should only be used in rare circumstances, as should administrative detention of food. Suspension of registration is a powerful FSMA tool, agreed Shannon Cole, senior director of science program management at the Grocery Manufacturers Association.

The agency invited written comments by July 6, but separate dockets will remain open for comments on provisions relating to:

• Inspection and compliance (FDA-2011-N-0366),
• Registration and suspension of registration of food facilities (FDA-2011-N-0390),
• Targeting of inspection resources for domestic and foreign facilities (FDA-2011-N-0391),
• Mandatory recall authority (FDA-2011-N-0392),
• Administrative detention of food (FDA-2011-N-0393) and
• Improving the Reportable Food Registry (FDA-2011-N-0394).

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Who's Who at EAS
Meet EAS Senior Consultant Norma Skolnik

Norma Skolnik has more than 30 years of regulatory experience in the food, dietary supplement and OTC drug industries. She joined EAS in January 2008 after ten years as director of regulatory affairs for Cadbury Adams USA (formerly Pfizer’s Adams Division). Prior to that role, she was associate director of regulatory affairs at Wyeth Consumer Healthcare and at the Lederle Consumer Health division of American Cyanamid.

Ms. Skolnik has considerable experience in providing regulatory guidance for new and marketed OTC drugs including claims development and advertising reviews. She has advised on strategies for gaining regulatory approvals and has implemented adverse event reporting programs for dietary supplements and OTC drugs.

Ms. Skolnik has broad experience in U.S., Canadian and Latin American regulatory issues. She has considerable expertise in resolving regulatory import issues and in implementing food safety and import safety programs. She is a frequent presenter at regulatory meetings on OTC drugs and supplements.

EAS Welcomes Three New Consultants

Nathan J. Treinish, Thomas J. Dunn, Jr., and Pablo A. Salazar are the three newest members of the EAS senior consulting team.

Nathan Treinish is an FDA regulatory attorney with extensive experience in legal issues impacting a pharmaceutical company and its products. He spent a significant portion of his career as counsel for Sanofi-Aventis U.S. and its predecessor companies. Most recently, he was associate general counsel in the company’s regulatory law, policy and privacy group. Early in his career, he served for three years as regulatory counsel in FDA’s administrative compliance branch. Subsequently, he joined Abbott Laboratories, where he provided legal advice and counsel to corporate divisions regarding company products, including food, drug and medical device law, federal election law, OTC drug advertising.

Thomas Dunn is an expert in flexible packaging with 30 years experience. He spent 20 of those years with Printpack Inc., Atlanta, Ga., where his responsibilities ranged from product development to regulatory compliance and intellectual property protection. Since January 2011, he has been managing director of Flexpacknology, Inc., offering consulting services to users and producers of flexible packaging, including assistance on food safety compliance, product development, and intellectual property issues.

Pablo Salazar, based in Guayaquil, Ecuador, is an expert in thermal processing and low acid canned foods. He was a primary South American contributor to FDA’s LACF pilot program, which included inspection, outreach training and capacity building in Ecuador, Peru, Colombia and Chile. He is currently president of Food Technologies Services Inc. in Guayaquil.

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What's New on FDA's Website

FDA Releases Draft Guidance on New Dietary Ingredient Notifications

FDA has released a draft of its long-awaited guidance explaining when a premarket safety notification is needed for a dietary supplement containing a new dietary ingredient. The draft also discusses how to prepare premarket safety notifications.

The agency says companies may use an alternative approach to that in the guidance, if the approach satisfies the statutory and regulatory requirements. When finalized, the guidance will represent FDA’s current thinking on NDIs and dietary supplements that contain NDIs.

The Food Safety Modernization Act required the agency to clarify, no later than 180 days after the date of law’s enactment, when a dietary supplement ingredient is an NDI, when the manufacturer or distributor of a dietary ingredient or dietary supplement should submit an NDI notification to FDA under section 413(a)(2) of the Food Drug and Cosmetic Act, the evidence needed to document the safety of an NDI, and methods for establishing the identity of an NDI. The 180 days ended July 5.

The draft guidance uses a question and answer format to explain FDA's views on what qualifies as an NDI, on when an NDI notification is required, on the procedures for submitting an NDI notification, the types of data and information that manufacturers and distributors should consider when they evaluate the safety of a dietary supplement containing an NDI, and on what should be included in an NDI notification. In addition, the draft includes questions and answers about parts of the dietary supplement definition that can affect whether a substance may be marketed as a dietary ingredient in a dietary supplement.

The draft guidance, titled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” is posted on the FDA website at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm. The agency inviting comments on the draft.

Next month we will be providing added insights on how these guidelines affect the guidance EAS has been providing our clients on NDIs.

Listed below are links to new additions to the FDA website for the month of June, 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: New York dietary supplement manufacturer enters into consent decree June 30, 2011


• FDA: Do not eat Evergreen Produce brand alfalfa sprouts or spicy sprouts June 27, 2011


• FDA modifies dosing recommendations for Erythropoiesis-Stimulating Agents June 24, 2011


• La FDA proporciona información segura y actualizado sobre los implantes de gel de silicona June 22, 2011


• FDA provides updated safety data on silicone gel-filled breast implants June 22, 2011


• FDA: Maryland food manufacturer enters into consent decree June 22, 2011


• HHS RELEASE: FDA unveils final cigarette warning labels June 21, 2011


• FDA approves first generic versions of the antibiotic levofloxacin to treat certain infections June 20, 2011


• FDA examines ways to improve consumer understanding of prescription drug ads June 20, 2011


• FDA issues draft guidance for early version of an artificial pancreas system June 20, 2011


• FDA unveils new global strategy to help ensure safety and quality of imported products June 20, 2011


• FDA: California seafood handler enters into consent decree June 17, 2011


• FDA approves Nulojix for kidney transplant patients June 15, 2011


• FDA approves first ceramic-on-metal total hip replacement system June 14, 2011


• FDA approves new test to help determine if breast cancer patients are candidates for Herceptin treatment June 14, 2011


• FDA Announces Changes to Better Inform Consumers About Sunscreen June 14, 2011


• Federal government takes action against drug manufacturer and distributor June 13, 2011


• FDA approves Potiga to treat seizures in adults June 13, 2011


• FDA approves redesigned labels for some Merck drugs June 10, 2011


• FDA clears new system to perform simultaneous PET, MRI scans June 10, 2011


• FDA takes ‘first step’ toward greater regulatory certainty around nanotechnology June 09, 2011


• FDA announces new safety recommendations for high-dose simvastatin June 08, 2011


• FDA: Pfizer will voluntarily suspend sale of animal drug 3-Nitro June 08, 2011


• FDA: DDS probiotic products seized June 07, 2011


• FDA statement on E. coli O104 outbreak in Europe June 03, 2011


• FDA seizes elderberry juice concentrate at Kansas company June 03, 2011


• FDA: Treatment with angiotensin receptor blockers for high blood pressure does not increase risk of cancer June 02, 2011


• FDA: Breast thermography not a substitute for mammography June 02, 2011


• FDA seeks injunction concerning uneviscerated seafood and other fish at Minnesota company June 01, 2011

• McNeil Consumer Healthcare Announces Voluntary Recall Oe One Product Lot Of TYLENO® Extra Strength Caplets 225 Count Distributed In The U.S. June 29, 2011


• Risvold’s Salads Inc Issues Allergy Alert On Undeclared allergens in Seafood Salad and Seafood Pasta Salad June 28, 2011


• Nestlé Purina Recalls Limited Number of Dry Cat Food Bags Due to a Potential Health Risk (Shipped Only to Colorado, Idaho and Oregon) June 27, 2011


• JFC International Inc. Issues Allergy Alert Due To Undeclared Milk Protein in UCC and Taitan Instant Drink Mix Products June 27, 2011


• Qualitest Pharmaceuticals Issues Voluntary, Nationwide Retail Level Recall of Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets, USP 50mg/325mg/40mg and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg June 26, 2011


• Endo Pharmaceuticals Issues Voluntary, Nationwide Recall of Two Lots of Endocet (Oxycodone/Acetaminophen, USP) Tablets, 10 MG / 325 MG June 24, 2011


• Eagle Produce, LLC Recalls Cantaloupe Due To Possible Health Risk June 24, 2011


• Nature Relief is Conducting a Voluntary Recall of Nature Relief Instant Wart and Mole Remover June 24, 2011


• Dole Fresh Vegetables Announces Precautionary Recall of Limited Number of Italian Blend Salads June 23, 2011


• Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls One Lot of RISPERDAL® Tablets and One Lot of Risperidone Tablets June 20, 2011


• Earth Fare Recall on Frozen Spicy Bean Burgers in Akron, Ohio Due To Possible Health Risks June 17, 2011


• TGF PRODUCTION LLC Issues An Alert On Uneviscerated Fish June 17, 2011


• Manufacturer for Publix Brand Caesar Salad Dressing Issues an Allergen Alert for Undeclared Fish, Soy and Gluten June 17, 2011


• Bariatric Advantage (Division of Catalina Lifesciences) Issues Allergy Alert on Undeclared Milk Protein in Chewable Multi Formula High in Vitamins A, D, E & K (Chocolate Mint Truffle) June 17, 2011


• Cinderella Sweets Issues Allergy Alert for Pound Cake Incorrectly Labeled As “Egg Free” June 16, 2011


• Staphylococcus Aureus in Queso Fresco Cheese June 15, 2011


• American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial Due to Particulates June 15, 2011


• Bedford Laboratories™ Statement Regarding Nationwide Voluntary Recall Of One Lot Of Indomethacin For Injection, USP 1 MG Single Dose Vial June 15, 2011


• Atlanta Corp. Recalls 9 pounds of "Royal Blue Stilton" cheese Because Of Possible Health Risk June 14, 2011


• US NUTRITION Issues Allergy Alert On Undeclared Fish In Daily Multible For Women 50 + Tablets June 08, 2011


• MGA Recalls Item # 504788BRATZ MAKEUPDesign Sketch Book Because of Possible Health Risk June 06, 2011


• Kashi Recalls Select Frozen Pizzas Because They May Contain Plastic Fragments June 06, 2011


• American Regent Initiates Nationwide Voluntary Recall of Methyldopate HCL Injection, USP 5 mL Single Dose Vial Due to Glass Particulates June 06, 2011


• Global Wellness, LLC Conducts a Nationwide Voluntary Recall of VIA XTREME ULTIMATE SEXUAL ENHANCER DIETARY SUPPLEMENT FOR MEN Due to Presence of Undeclared Drug June 06, 2011


• Voluntary Worldwide Field Correction Issued for the S98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps June 06, 2011


• Simply Thick, LLC Announces The Voluntary Recall Of Products Manufactured By Thermo Pac, LLC At Their Stone Mountain, GA Food Processing Plant June 04, 2011


• Bravo! Issues Nationwide Recall of Bravo! Pig Ears Dog Chews Because of Possible Salmonella Health Risk June 03, 2011


• Churchill Medical Systems, A Vygon Company, Skin-Prep Wipes used in Convenience Kits June 03, 2011


• Aidapak Services, LLC Initiates Nationwide Voluntary Recall on ALL Repackaged Pharmaceuticals by Aidapak Services, LLC Due to Potential Cross Contamination with Beta Lactam Products June 02, 2011


• Azar Nut Issues Allergen Alert on Undeclared Milk in Mountain Trail Mix June 01, 2011

• June 22, 2011 Transforming Lives Through Diabetes Research
  Charles Zimliki, Ph.D., before the Senate Committee on Homeland Security and Governmental Affairs
• June 02, 2011 Pathway to FDA Medical Device Approval: Is There a Better Way?
  Jeffrey Shuren, M.D., J.D., before the House Committee on Oversight and Government Reform, Subcommittee on Health Care, District of Columbia, Census and the National Archives

• June 29, 2011
• June 22, 2011
• June 15, 2011
• June 08, 2011
• June 01, 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 on Supplement GMP Shortcomings

GMP qualification and testing provisions are still tripping up supplement firms, according to EAS Vice President Dean Cirotta, who was quoted in a June 20 article in The Tan Sheet on how inadequate documentation is a frequent stumbling block for manufacturers who receive a form 483 following an FDA inspection.

“I think companies are trying to respond to these 483 letters without any experience in doing so,” Cirotta said, adding that companies often neglect to specify dates by which corrective actions will be completed and to provide proof of those actions.

The article included remarks by Daniel Fabricant, director of CFSAN's Division of Dietary Supplement Programs, who said the center is concerned about specific observations that pop up repeatedly.

“We‘re seeing [problems with] identity testing on incoming ingredients, finished product testing, master manufacturing records,” he said, at the Orange County Regulatory Affairs Discussion Group's joint conference with FDA in Irvine, California, June 9.

“These are, if you will, the pillars of GMP compliance,” he said.

Consultant Joy Joseph said the top violation she sees is a failure to qualify vendors, often because of confusion between vendor qualification and Certificate of Analysis qualification.

Norma Skolnik Makes Presentation on OTC Drugs, Supplements and Cosmetics

EAS Senior Consultant Norma Skolnik will provide an overview of FDA regulations relevant to OTC drugs, dietary supplements and cosmetics, in a presentation at the Controlled Release Society (CRS) annual meeting and expo, held this year at the Gaylord National Convention Center in National Harbor, Maryland, July 30–August 3.

The presentation will cover regulatory requirements for U.S. marketing of products in these categories, including registration requirements, GMPs, labeling, and product claims. The presentation will focus on what makes a product a drug vs. a dietary supplement or a cosmetic and on how to avoid regulatory problems.

EAS Exhibits as IFT Returns to New Orleans

EAS President Ed Steele and Vice President Betty Campbell staffed the EAS exhibit booth at the Institute of Food Technologists Food Expo in New Orleans, June 11–14. EAS Senior Consultant Jim Hoadley (pictured here) took time out at the IFT event to sample the local crawfish. It was good to see that New Orleans is recovering from the double hits of hurricane-related flooding and a major oil spill in the Gulf.

The IFT is an excellent place to meet and exchange ideas with food professionals from countries around the world. Traffic at the EAS exhibit booth was particular heavy this year as more and more industry representatives are seeking consulting assistance to comply with FDA’s changing regulatory requirements. Next year’s IFT Annual Meeting and Food Expo will be held in Las Vegas June 25-28, 2012. We hope to see you there.

New Food Labeling and Dietary Supplement GMP Seminars

The next EAS Food Labeling Compliance Review seminar will be held at the EAS Consulting Group Training Facility, 1940 Duke Street, Suite 200, Alexandria, Virginia, on November 8–9, 2011. This seminar will review FDA’s latest thinking on food labeling requirements and will include 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 EAS Dietary Supplement GMP Seminar will be held November 15–16, 2011. Participants 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.

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Upcoming Events

Controlled Release Society (CRS) Annual Meeting and Expo
July 30–August 3, 2011
National Harbor, Maryland

PDA/FDA Joint Regulatory Conference
September 19–20, 2011
Washington, DC

EXPO East
Sept. 21–24, 2011
Baltimore, Maryland

Supply Side West
October 12–13, 2011
Las Vegas, Nevada

Regulatory Affairs Professional Society
October 22–26, 2011
Indianapolis, Indiana

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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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