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EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
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August 2008 |
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In this Issue:
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Upcoming EAS Events |
- Dietary Supplement GMP Seminar
[more]
- Ensuring Regulatory Compliance of Dietary Supplement Laboratories [more]
- HBA Global Expo and Educational Conference [more]
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From the Desk of the President:
A Focus on Cosmetics
Dear Reader:
Welcome to the third issue of EAS-e-News, our free, monthly newsletter for industries regulated by the Food and Drug Administration. EAS-e-News aims to provide an easy-to-read summary of FDA’s latest activities, while letting you know what we can do to help with your compliance needs.
FDA officials continued to wrestle with the one of nation’s largest produce-related illness outbreaks last month. Meanwhile, we quietly passed the June 2008 deadline for implementation by large firms of FDA’s GMP rule for dietary supplements. Mid-size companies have until June 2009 to come into compliance and smaller operations have until June 2010.
You may know that EAS provides regulatory expertise for dietary supplements, drugs, medical devices and foods. But you may not be aware that our consultants also offer compliance assistance to cosmetics and personal care firms. This month we feature insights on the cosmetics industry as a reminder not to overlook the importance of cosmetic safety. EAS Senior Consultant Bill Schwemer provides his thoughts on “Cosmetics: The Good, The Bad and the Dangerous” in our Issue of the Month section.
Mr. Schwemer, a former FDA Associate Commissioner for Regulatory Affairs is also featured in our Who’s Who at EAS section this month. A key member of the EAS team, he has a unique perspective, because he has been both a developer of regulations and policy at FDA and a designer of good manufacturing practice implementation programs on the industry side.
Mr. Schwemer and EAS Vice President Elizabeth Campbell are scheduled to speak at the Third Annual International HBA Safety, Regulatory and Certification Summit, in New York, September 10. The event is part of the HBA Global Exposition and Educational Conference, September 9-11. Mr. Schwemer will also be joining me at the EAS exhibition booth at the HBA conference. So please come and see us at booth 1149.
In a related move, EAS has recently joined the Personal Care Products Council (formerly the Cosmetic, Toiletry and Fragrance Association), the leading national trade group for the cosmetic and personal care products industry.
EAS-e-News is designed to offer easy access to new information on FDA’s website. Below you will find numerous links, including one to Commissioner Andrew von Eschenbach’s “Andy’s Take” on adverse event reporting for drugs and FDA warnings, which he cites as evidence that the regulatory system is working.
Many thanks to readers who took the time to comment on our first two issues. We have included some of those comments this time. I encourage you to let us know what you think of EAS-e-News.
Sincerely,
Ed Steele,
President
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Who's Who at EAS:
Meet EAS Senior Consultant, William L. Schwemer
William L. (Bill) Schwemer is a key member of the EAS consulting team. A former Associate Commissioner for Regulatory Affairs at FDA, his focus at EAS is on pharmaceuticals, non-prescription drugs, dietary supplements and cosmetics.
Mr. Schwemer began his FDA career in 1962 as an investigator in FDA’s Detroit District Office. Over the course of 30-years, he held numerous roles in the agency, including that of Special Assistant to the Deputy FDA Commissioner for Policy. Prior to transferring to FDA’s headquarters, he was an investigator, a supervisor and a compliance officer.
From July 1993 through January 2003, as a senior consultant with AAC Consulting Group/Kendle, he advised domestic and international clients on FDA matters. While with AAC, he co-authored and was technical editor of the Application of Pharmaceutical GMPs, published by the Food and Drug Law Institute in 1997.
In 2003, Mr. Schwemer became vice president of quality assurance and regulatory affairs at a contract manufacturer of personal care items including non-prescription drugs. He had direct 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 retained as 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 is Regulatory Affairs Certified and has received certificates for completing ISO-9000 lead assessor and HACCP training.
“We are very fortunate to have someone with Bill’s depth of expertise on the EAS team,” says EAS President Ed Steele.
Mr. Schwemer is available to help you with the implementation of quality systems or the evaluation of compliance with FDA’s Current Good Manufacturing Practices.
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Issue of the Month
Cosmetics: The Good, the Bad, and the Dangerous
By EAS Senior Consultant William L. Schwemer
We have seen many cosmetics firms reduce their quality, regulatory and training staffs because they are no longer concerned about the possibility of an FDA inspection. But this has increased the risk that a non-compliant firm will make a cosmetic that will seriously harm the public – and bring down the wrath of the regulators on the industry.
The Food, Drug and Cosmetic Act defines “cosmetic” in 21 USC 321(i) as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance [...].” To remember the definition, think of it as like decorating an ice cream cone with sprinkles or a dip.
I have worked with many cosmetics companies as a consultant on a variety of issues from Good Manufacturing Practices through microbiological contaminations. Overwhelmingly, they wished to comply with the law and regulations. But I have seen a disturbing trend in recent years, with some clients asking not what they must do to comply with the law, but how far they can go with borderline or violative conduct before FDA will take action. This is a high-risk strategy.
Organic and Natural Trend
The shift in consumer preference toward organic and natural dietary supplement products has prompted cosmetics firms to explore the addition of nutritional ingredients in cosmetics formulas. Because most cosmetics are applied topically and supplements are ingested, this can be a difficult change. So far, I have seen just one formula that FDA might find acceptable, with the right directions for use and claims.
Similarly, removing a robust preservative from a cosmetic and replacing it with a natural preservative can be dangerous, because the consumer may contaminate the product after it is opened. I worked with one contract manufacturer who advised customers to formulate the product with a robust preservative system. If the customer still wished to use a natural preservative, they had to supply a statement that they accepted responsibility for any liability that might result.
“Cosmeceuticals”
The Food Drug and Cosmetic Act, 21 USC 359, exempts cosmetics from the drug provisions unless the cosmetic is also a drug or device or a component thereof. Products that make both drug and cosmetic claims and therefore meet both the definition of a “drug” and a “cosmetic” are often unofficially referred to as “cosmeceuticals.” Cosmeceuticals must be made under the current GMP regulations for pharmaceuticals. They must also meet the formulation and labeling requirements of an OTC Drug Monograph or have FDA’s approval of a New Drug Application.
Firms that manufacture cosmeceuticals appear to be inspected more often than firms that manufacture only cosmetics. The more frequent inspections likely result from the statutory requirement that drug firms be inspected biennially. Cosmeceuticals generally have no dosage restrictions.
Some cosmeceuticals manufacturers have quality systems that rival those in the drug industry, while others are as poor as any I have seen in any industry. This is a significant public health threat. But it also poses a serious risk to all cosmetics firms.
EAS can help keep your cosmetic products in compliance and keep your firm out of trouble with the regulators.
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What's New on FDA's Website:
Listed below are links to new additions to the FDA website for the month of July, 2008. Use of this section of EAS-e-News is intended to provide an “easy” way to keep current with FDA news and information.
FDA Press Releases
- FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample July 31, 2008
- FDA Extends Consumer Warning on Serrano Peppers from Mexico July 30, 2008
- Federal Agents Seize more than $24 Million in Unapproved New Drugs July 30, 2008
- FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder July 29, 2008
- FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley July 28, 2008
- U.S. Grown Jalapeño and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak July 25, 2008
- Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product July 24, 2008
- FDA Rule and Companion Guidance Make Early Stage Clinical Drug Development Safe and Efficient July 18, 2008
- FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals July 17, 2008
- FDA Reaches Settlement with California Hearing Device Maker July 17, 2008
- FDA Revises Process for Responding to Drug Applications July 9, 2008
- FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs July 8, 2008
- FDA Approves New Genetic Test for Patients with Breast Cancer July 8, 2008
- FDA Food Protection Plan Shows Significant Progress July 2, 2008
Recalls and Safety Alerts
- Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets July 31, 2008
- FDA Extends Consumer Warning on Serrano Peppers from Mexico July 30, 2008
- Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient July 28, 2008
- FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley July 28, 2008
- Vita Food Products Issues Alert Regarding Vita Nova Salmon July 25, 2008
- U.S. Grown Jalapeño and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak July 25, 2008
- Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product July 24, 2008
- Publix Issues Recall for No Sugar Added Cherry Pie July 24, 2008
- EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient July 23, 2008
- Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk July 21, 2008
- Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk July 19, 2008
- Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid July 18, 2008
- Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger July 16, 2008
- Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico July 14, 2008
- Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk July 9, 2008
- Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk July 9, 2008
- Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules July 1, 2008
July Archive of The FDA this Week: Andy's Take Congressional Testimony
Enforcement Reports
What's New by Topic
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EAS in Action:
EAS Participates in Natural MarketPlace 2008
EAS President Ed Steele and Vice President Carl Reynolds were busy last month at the Natural Products Association’s annual convention and trade show, Natural MarketPlace 2008, in Las Vegas, July 17-19. The two enjoyed speaking with those who stopped at the EAS exhibit booth to learn of the various EAS services available to the dietary supplement industry. Of particular interest to show attendees was how EAS can help firms assess their current level of compliance with the new dietary supplement GMPs and develop plans to correct deficiencies found.
In addition Steele and Reynolds presented a “Regulatory Update” session on the show floor, which addressed FDA’s new GMP requirements, as well as allergen labeling, adverse event reporting, and qualified health claims for dietary supplements. In a separate session, Mr. Reynolds, along with NPA Counsel, Daron Watts of Sidley & Austin, provided attendees with tips on “How to Survive a Visit from FDA.”
EAS is one of only two companies that NPA has certified to conduct certification audits for the NPA GMP Certification Program. Mr. Reynolds served as an instructor in a day long seminar held in conjunction with MarketPlace 2008 for firms interested in possible participation in the program. Forty-five people attended this NPA sponsored training.
EAS to Speak On “Beauty from the Inside”
The growing consumer interest in dietary supplements and “functional” foods has drawn cosmetics manufacturers to develop nutritional products with claims that the products enhance beauty from the inside.
EAS Vice President Elizabeth Campbell will offer regulatory insights on the labeling of such products at the upcoming HBA Safety, Regulatory and Certification Summit, in New York, September 10.
The claims used on these products are subject to various FDA rules, so companies need to be careful to avoid making claims that will put their products at regulatory risk. Ms. Campbell will discuss the current FDA requirements for the kinds of claims most often used for “beauty from the inside” products.
In a separate presentation, EAS Senior Consultant William Schwemer will discuss regulatory transfer between pharmaceuticals and personal care industries. Many innovative technologies have been shared by the pharma and personal care industries. Many transfers have involved troublesome formulation problems related to liquid and semi-solid products. They include solutions, suspensions, lotions, gels, and ointments, the delivery forms most common to both of these industries.
In the past, both sides have had to address issues such as creating formulas that mask the flavor, odor or color of certain raw materials or active ingredients. In recent years, personal care companies have been increasingly including drug ingredients in their formulas and make drug claims on their labels. For example, sunscreens are now commonly included in formulas for moisturizers.
Makers of dandruff shampoos, antiperspirants, antibacterials and other “cosmeceuticals” also must consider what quality systems must be in place for compliance with FDA’s Current Good Manufacturing Practices Regulations for Pharmaceuticals. Mr. Schwemer’s presentation will include a primer on the official definitions of drugs and cosmetics, as well as what it takes for makers of low risk products to comply with CGMPs.
The one-day symposium is part of the HBA Global Exposition and Educational Conference, September 9-11. Mr. Schwemer will be joining EAS President Ed Steele at the EAS exhibit booth at the HBA expo, so please drop by and see them at booth 1149.
Be Our Guest at HBA Global Expo
EAS Consulting Group is pleased to extend an invitation for a Complimentary Guest Pass (valued at $25) to visit HBA Global Expo when you register online at www.hbaexpo.com!
- HBA Global Expo
September 9-11, 2008
Jacob K. Javits Convention Center, New York City
To register online for a FREE Exhibit Hall Pass Compliments of EAS Consulting Group follow these simple instructions:
- Click thru to www.hbaexpo.com “Register Now” and complete registration details.
- Enter PRIORITY CODE EXH295 while registering.
- Submit your registration and print a copy of the confirmation.
(An e-mail confirmation will follow within 24 hours.)
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Upcoming Events
Seminars
Two New Dietary Supplements Seminars
Now that the final regulations on good manufacturing practices (GMPs) for dietary supplements are in effect for large firms and will become effective for medium sized firms in June 2009, EAS is conducting seminars to train the industry on the new rule. Our next dietary supplement GMP seminar will be held at the EAS headquarters in Alexandria, VA, September 30-October 1.
This intensive training program is given by former FDA compliance officials, and 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.
Our second upcoming seminar is titled Ensuring Regulatory Compliance of Dietary Supplement Laboratories, October 2-3.
FDA’s CGMP rule places significant emphasis and responsibilities on the dietary supplement laboratory and QC personnel. FDA focuses on laboratory controls during inspections to ensure that analytical results are credible and the laboratory is CGMP compliant. FDA trend data over the past several years shows that deficiencies in laboratory controls are among the most frequently cited observations during inspections of pharmaceutical companies.
The two day course will provide the knowledge and skills for evaluating, auditing, managing, and improving the CGMP compliance of your in-house and/or contract laboratory. You will gain knowledge for identifying and closing CGMP gaps and implementing the 15 key laboratory quality systems. You will be provided with examples of lab CGMP deficiencies from FDA-483 drug citations and recommendations for practices and procedures to ensure and demonstrate CGMP compliance.
The instructors for both seminars will be EAS Senior Consultant Robert Fish, former director of FDA’s Division of Field Operations, and EAS Senior Consultant William Ment, a former director of FDA’s Baltimore District Laboratory.
For more details, visit www.easconsultinggroup.com.
Tradeshows
Visit the EAS Consulting Group exhibit at the following tradeshow:
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Useful Publications and Regulatory Tools
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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
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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
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Dietary Supplement Labeling Compliance Review, 3rd edition
A value labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell
Hardbound book |
$ 184.99 / set
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Food Labeling Compliance Review, 4th edition
A value labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell.
Hardbound book and CD |
$ 209.99 / set
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To purchase any items listed above download our  |
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© EAS Consulting Group, LLC, 2008
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