Murphy Slaw 0205

MURPHY’S LAW
FEBRUARY 2005
FOOD & DRUG PRACTICE

www.kl.com
Contents
GENERAL NEWS 1
COSMETICS 3
DIETARY SUPPLEMENTS/FOOD 4
OTC DRUGS 7
MEDICAL DEVICES 9
INTERNATIONAL UPDATE 10
K&L Regulatory Update MEETINGS AND CONFERENCES 13
GENERAL NEWS
FDA Federal Register: Annual Comprehensive List of Guidance Documents at the Food and
Drug Administration. Includes actions for hydroquinonle, lip protectant labeling, OTC drug
convience size labeling, and UVA/UVB sunscreen.
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-155.pdf
Acting FDA Commissioner Outlines Priorities for Next Six Months
http://www.fda.gov/bbs/topics/news/2004/NEW01098.html
FDA Federal Register: Establishment of Animal Drug User Fee Rates and Payment Procedures
for Fiscal Year 2005.
FDA warned Rhode Island Governor Donald Carcieri (R) that the state’s new law allowing
Canadian pharmacies to ship prescription drugs to state residents would violate federal law.
However, the agency has no immediate plans to sue the state, an FDA official told FDA Week.
Rhode Island’s new law will allow the state to license Canadian pharmacies. The law was
effective January 2005. Carcieri supports the measure but allowed the bill to be enacted
without his signature. (“FDA Week” July 9, 2004)
FDA Warns Consumers about Counterfeit Drugs Purchased in Mexico
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01303.html
Viagra said to protect lungs and heart in high altitude
http://news.bbc.co.uk/2/hi/health/3534558.stm
Breast cancer drug breakthrough
http://www.thisislondon.co.uk/news/articles/15179315?source=Evening%20Standard
Arthritis drugs found associated with TB cases: Medicines used to treat autoimmune diseases
such as rheumatoid arthritis are linked to some cases of tuberculosis, according to FDA
officials. The warning was based on a discovery that 12 people who had been taking Remicade
or Enbrel tested positive for TB.
Genes apparently the reason some hepatitis C cases cure themselves
http://www.sfgate.com/cgi-bin/article.cgi?file=/news/archive/2004/08/05/
national1409EDT0634.DTL
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New York City filed a suit naming nearly every U.S. pharmaceutical manufacturer, accusing them of
overcharging the Medicaid program through fraud and unfair and deceptive trade practices. The suit,
brought against 44 companies and their subsidiaries, is the largest of several suits brought recently
by states and cities making similar charges in an attempt to reclaim some of estimated tens of
millions of dollars they believe were charged to the program beyond what the cost should have been.
A spokesperson for the pharmaceutical industry did not comment on the lawsuit, but argued drug
costs only represent one-sixth of total Medicaid expenses.
Millions on Prozac
http://www.ivanhoe.com/channels/p_channelstory.cfm?storyid=9131
Addiction Disorder
http://washingtontimes.com/national/20040803-110059-2460r.htm
Herpes from Circumcision
http://www.healthfinder.gov/news/newsstory.asp?docID=520392
Successfully Treating Early Alzheimers
http://www.hon.ch/News/HSN/520476.html
Collembola Implicated in Delusory Parasitosis: “I told you so!” The arthropod Collembola
(Springtails) is a common factor in patients originally diagnosed with delusory parasitosis, according
to the results of a case-controlled study published in the current (June) issue of Journal of the New
York Entomological Society. “Delusory parasitosis…is a presumed psychiatric condition ascribed to
individuals who are convinced, in the absence of any empirical evidence, that they are infected with
an insect or parasite. (Medscape Medical News, August 10, 2004)
USA: USDA to defray organic certification costs: The US Department of Agriculture announced that
in the US $1M in federal funds is available to defray the cost of organic certification in 15 states.
The Agricultural Management Assistance Program, authorized by the Federal Crop Insurance Act,
will distribute money in proportion to the number of organic producers in each state. The states, in
turn, will reimburse eligible producer for up to 75% of their certification expenses, up to $500. (just-
food.com)
Proposition 65: FDA Trumps California Nicotine Warning: The California Supreme Court says FDA
has the authority to dictate labeling language on nicotine replacement therapy products and does not
have to require use of California Proposition 65 language. The court found that FDA had rejected
the Proposition 65 warning on the products because the risk communicated by the proposed warning
was outweighed by the greater risk that a warning would ‘scare consumers into foregoing use of a
product that in most cases will be to their benefit. Thus, the court concluded, FDA had preempted
Proposition 65. The court held that because the products are designed to help people stop smoking,
and it is worse for a pregnant woman to smoke than to use the products, the FDA-approved warning
should prevail.” The FDA warning states: If you are pregnant or breast-feeding, only use this
medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to
stop smoking without using any nicotine replacement medicine. This medicine is believed to be
safer than smoking. However, the risks to your child from this medicine are not fully known.”
Doctors who sued Yale win $5.5 million
http://www.post-gazette.com/pg/04210/352898.stm
Possible Marker for Osteoarthritis Found: High levels of Hyaluronic acid pointed to joint trouble
http://articles.health.msn.com/id/100099944/site/100000000/
Excess Weight Can Compromise Birth Control Pills

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Ranks of uninsured grow to highest since ‘98
http://www.usatoday.com/money/industries/health/2004-08-26-uninsure_x.htm
California Environmental Protection Agency Air Resources Board: Consumer Products
Regulations: January 2005 Requirements
http://www.arb.ca.gov/enf/advs/advs330.pdf and http://www.arb.ca.gov/enf/advs/advs329.pdf
COSMETICS
Regulatory Update
In case you missed it, the FDA Office of Cosmetics & Colors has moved to Center for Food Safety &
Applied Nutrition headquarters in College Park, MD facility at the end of October. Relocation
includes Division of Cosmetics and Compliance, regulations team, special projects team and
Division of Colors Certification and Technology. Cosmetics Technology Branch already has
relocated. Mailing address for all cosmetics office divisions will remain at CFSAN headquarters,
(Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Parkway, College Park, MD 20740-3835). The Office of
Cosmetics & Colors moved to temporary facilities in 2002 pending construction of additional space
in College Park.
FDA Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha
Hydroxy Acids as Ingredients
http://www.cfsan.fda.gov/~dms/ahaguid2.html
Reclassification of certain cosmetic products as drugs discouraged by McNeil Personal Products
Company in recent comments to FDA. Agency has “ample regulatory authority” to take action
against manufacturers who cross the line into drug claims, firm adds. Separately, J&J Consumer &
Personal Products echoes CHPA’s endorsement of continued OTC availability of urinary analgesics
based on history of use, consumer understanding and labeling.
http://www.fda.gov/ohrms/dockets/98fr/03-32102.pdf
Safety and Effectiveness Update

Tumeric, the new active cosmetic ingredient
http://www.cosmeticsdesign.com/news/news-NG.asp?n=56987-tumeric-the-new
Essential oils in cosmetics may fight super bugs
http://www.cosmeticsdesign.com/news/news-ng.asp?id=56957-essential-oils-in
Enforcement
FDA Warning Letter: Z Cosmetica USA, LLC, deviation from Current Good Manufacturing Practice
Regulations.
http://www.fda.gov/foi/warning_letters/g4895d.pdf
Business and Industry Update

Prada fashion label introduces first fragrance with rollout of Prada Fragrance, according to Puig
USA, which is partnering with the design house to launch the scent. Debuting in Neiman Marcus
and Prada stores, as well as other select retailers nationwide, scent puts modern spin on ancient
essential oils, according to the company. Fragrance is being supported with print ads running in
women’s books, including InStyle, Town & Country, Vanity Fair. (“The Rose Sheet” October 11,
2004)
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Woman Slaps Estee Lauder with Lawsuit
http://www.10news.com/news/4048373/detail.html
DIETARY SUPPLEMENTS/FOOD
Regulatory Update
Dietary supplement firm has finally discontinued manufacturing skin cream SkinAnswer and two
nutritional supplements, Benefin and MGN-3, the company announces, after a permanent injunction
was issued July 13 barring the firm from selling the products unless approved by FDA. “We are very
disappointed and will pursue an appeal,” the company says in a statement. Lane Labs argues the
products represent a breakthrough in the natural health industry, but court rules that the items,
marketed as cancer therapies, are unapproved new drugs. (“The Rose Sheet” July 19, 2004)
Final Guidance – Q&A Regarding Registration of Food Facilities
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0545-gdl0004.pdf
FDA Guidance for Industry: Prior Notice of Imported Food Contingency Plan for System Outages:
http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0361-gdl0001.pdf
FDA Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section
403(r)(6) of the Federal Food, Drug, and Cosmetic Act; Availability.
FDA Revised Compliance Policy Guide Regarding Prior Notice of Imported Food Under the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002; Revised Joint Food and
Drug Administration Customs and Border Protection Plan for Increasing Integration and Assessing
the Coordination of Prior Notice Timeframes:
FDA Federal Register: FDA Withdraws Experimental Study of Petitioned Health Claims for
Glucosamine and Chontroitin Sulfate.
The Institutes of Medicine (IOM) has called for amendments to the Dietary Supplement Health and
Education Act (DSHEA).
“It is unfortunate that such an imminently qualified group of experts was presented with such flawed
assumptions about the current regulatory scheme for dietary supplements,” said Michael McGuffin,
American Herbal Products Association (“AHPA”) president. “The recommendations that resulted from
all of the effort that went into this federally funded project have been wasted, and the very credibility
of the IOM has been damaged.”
The prepublication version of the report, Use of Complementary and Alternative Medicine (CAM) by
the American Public, was made available on IOM’s website and a press conference was held in
Washington DC to announce its publication. The report was purportedly prepared “to explore
scientific, policy, and practice questions that arise from the significant and increasing use of CAM
therapies by the American public.” One chapter of the report was dedicated to dietary supplements, as
was a significant portion of the press conference.

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Examples of errors in the report cited by APHA include failure to recognize the law’s provision for
notification and safety review of new dietary ingredients and the food GMP standards that all
manufacturers are currently required to meet. The document cites a survey of public attitudes about
dietary supplements: “Slightly more than half (53 percent) were aware that supplements are not
regulated by the government.” “What is sad about this citation is that it makes it apparent that 100
percent of the panel was misinformed about the regulatory status of dietary supplements,”
commented McGuffin. “How can anyone propose amendments to a law that they do not
understand?”
IOM’s press release can be read at
http://www4.nationalacademies.org/news.nsf/isbn/0309092701?OpenDocument
The full IOM report is available online: http://www.nap.edu/catalog/11182.html, and the chapter on
dietary supplements (Chapter 9) can be purchased there for $3.00 by following the prompts to
“purchase PDF chapters.” (AHPA Update, January 12, 2005)
In APHA comments to FDA on substantiation of herbal product structure/function claims Michael
McGuffin, AHPA’s president stated: “FDA should acknowledge that countries all over the world, from
Canada to Europe and Australia, have developed policies to allow traditional use claims for herbal
products,”. “Substantiation of a traditional claim for an herbal product should not require new
clinical data so long as the product formulation, dose, and claim conform to established traditional
usage records.” AHPA provided in its comments numerous specific examples of monographs and
“core-data” files that have been prepared by these international government agencies.
AHPA’s comments also noted that the Federal Trade Commission (FTC) has stated that an option to
developing “confirming scientific evidence” for claims based on historical or traditional use is to
present such claims “in such a way that consumers understand that the sole basis for the claim is a
history of use of the product for a particular purpose,” and “should make sure that the product it is
marketing is consistent with the product as traditionally administered.” Similarly, the final report of
the Commission on Dietary Supplement Labels recommended that “the composition of the
[traditional use] product should correspond with the material for which such claims of historical use
may be made,” and would need to be “carefully qualified to prevent misleading consumers.” AHPA
expressed support in its comments for the recommendations of the FTC and the Commission.
FDA Announces Qualified Health Claims for Omega-3 Fatty Acids
http://www.fda.gov/bbs/topics/news/2004/NEW01115.html
Enforcement
FDA Warning Letter: FDA warns company supplement is unapproved new drug because labeled for
treating Alzheimer’s disease and dementia.
FDA Warning Letter: FDA found claims inappropriate for dietary supplements
http://www.fda.gov/cder/warn/cyber/2004/CL104E.pdf
FDA Courtesy Letter to CCA Industries
http://www.fda.gov/ohrms/dockets/dailys/04/aug04/081004/97s-0163-let00764-vol23.pdf
FDA Courtesy Letter to Physician Health Station LLC dba Physician Health Network.
FDA Courtesy Letter to Nutritional Specialties, Inc.

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FDA Courtesy Letter to Natural Factors Nutritional Products, Inc.
FDA Courtesy Letter to Spirit Science USA Inc
Nutramax Laboratories may use Senior Moments name but must substantiate memory loss claims in
future advertising, promotional materials, according to proposed FTC consent agreement. Agency
charges firm with making unsupported claims in TV, print, radio ads from 2002-2003. (“The Tan
Sheet” July 19, 2004)
During an inspection of Mind’s Eye Juice Company FDA noted labeling difficulties with Zen-Mind,
Electra-Mind, Clear-Mind and Super Green Juice. Zen-Mind, Electra-Mind, Clear-Mind and Super
Green Juice were found to be misbranded and adulterated because: 1) they were labeled as a dietary
supplement but did not meet the regulatory definition of a dietary supplement, which excludes
products represented for use as conventional foods. This product was presented as a conventional
food; 2) because the labeling failed to bear a common or usual name that accurately identifies or
describes a beverage that contains fruit or vegetable juice; and 3) because it contained juice but the
label failed to include a statement concerning the total percentage of juice. In addition, Zen-Mind
bore or contained an unsafe food additive (Kava Kava (Piper methysticum), also known as kava);
Electra-Mind ingredient statement listed “Siberian Ginseng” as an ingredient. Siberian Ginseng does
not meet the regulatory requirements to be considered “ginseng”; and Super Green Juice’s label
included the statement “Fortified with…” and did not comply with the regulatory definition of the
claim “fortified”.

Chemical in lettuce baffles industry
http://www.californianonline.com/news/stories/20041201/localnews/1677298.html
Study: High-carb diets may increase risk of breast cancer
Diets high in carbohydrates may put women at greater risk for breast cancer, according to a new study.
The study’s author said its results were not cause enough to change one’s diet, “but it’s a cautionary
sign,” he said.
New white flour incorporates benefits of multigrain
http://www.usatoday.com/money/industries/food/2004-08-08-bread_x.htm
L-carnitine supplement may help infertile men
http://www.foodnavigator.com/news/news.asp?id=10131
Chitosan fails to reduce kilos, finds study
http://www.nutraingredients-usa.com/news/news-NG.asp?id=54318
Lutein, zeaxanthin appear to restore eye cell health
http://www.nutraingredientsusa.com/news/news-NG.asp?id=54343
Grapefruit juice may contain cancer-fighting compounds
http://foodnavigator.com/news/news-NG.asp?id=54361
Steady Diet of Red Meat Increases Colon Cancer Risk
Chamomile Tea May Have Medicinal Value
Fruits, Vegetables Don’t Protect Against Breast Cancer

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New antioxidant comes to market
http://www.foodnavigator.com/news/news.asp?id=10256
OTC DRUGS
Regulatory Update
FDA Draft Guidance for Industry: Labeling OTC Human Drug Products Questions and Answers:
http://www.fda.gov/cder/guidance/5008dft.pdf
FDA Federal Register: Orally Administered Drug Products for Relief of Symptoms Associated with
Overindulgence in Food and Drink for Over-the-Counter Human use; Proposed Amendment of the
Tentative Final Monograph.
FDA Federal Register: Over-the-Counter Drug Products; Safety and Efficacy Review; Additional
Antidiarrheal Ingredient.
Sinofresh petition on cetylpyridium chloride is not within the antiseptic TFM parameters, Schering-
Plough states in comments to FDA July 15. Venice, Florida firm is attempting to include a nasal spray
in a monograph for oral health care products, the Afrin nasal spray marketer adds. Comments respond
to a citizen petition submitted to FDA last year by Sinofresh, urging the agency to include .05% CPC
as Category I in the oral antiseptic health care TFM.
FDA Federal Register: FDA proposes changes to OTC Drug Monograph for Nasal Decongestants.
Pfizer looks to capitalize on underdevelopment of hand sanitizer market with Purell acquisition from
GOJO industries announced Oct. 5. Firm cites Purell’s market leading status, small household
penetration of the category as growth opportunities. Pfizer will acquire food, drug and mass retail
channel marketing rights to the brand, while GOJO will maintain institutional sales to hospitals and
schools. (“The Rose Sheet” October 11, 2004)
Enforcement Update
FDA says the District of Columbia should not be relying on Minnesota and Wisconsin state Web sites
for drugs imported from Canada, especially when those two states have had bad experiences with
importation. In an 8/20 letter to Washington, DC mayor Anthony Williams, FDA associate
commissioner for policy and planning William Hubbard says he doubts that Williams or any other
public official will be able to do a better job of ensuring that Canadian pharmacies send only safe
and high quality drugs to his constituents, when Minnesota and Wisconsin have been unable to do
so. (FDAWebview)
Former NuCare Pharmaceuticals CEO Christopher Lamoreaux sentenced to 21 months in federal
prison and ordered to pay $115,278.54 to the company for two counts of mail fraud involving
counterfeit versions of Pfizer’s Lipitor and Bextra, FDA says. Lamoreaux was found guilty of
accepting kickbacks for negotiating a contract for NuCare to purchase and repackage counterfeit and
diverted drugs from Albers Medical. He was convicted in Kansas City, Mo. Federal court in July
following an investigation by FDA’s Office of Criminal Investigation. (“The Pink Sheet” November
15, 2004)

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FDA Warning Letter: Ultra Seal Corp, strict control was not exercised over labeling issued for use
in drug product labeling operations.
FDA seizes pesticide residue-contaminated ginseng supply following inspection. Approximately
$10,000 of product was confiscated from N.J.-based supplement firm FCC Products. Recall of
tainted ginseng is second in several months, following NOW Foods’ withdrawal of the herbal in
November. (“The Tan Sheet” January 3, 2005)
Product Safety and Effectiveness Update

FDA issues public health advisory recommending strict adherence to OTC NSAID labeling in wake
of ADAPT trial results. Agency notes it is gathering data from all ongoing studies involving COX-2s
to evaluate further action. NIH-sponsored studies involving Celebrex number roughly 40, with
many being overseen by individual investigators, CDER’s Jenkins says. (“The Tan Sheet”, January
3, 2005)
Topical pain relief ads for Joint-Ritis reference Vioxx, NSAID safety woes including heart attacks,
stomach ulcers “or worse.” Radio spots credt the menthol-containing cream and ointment with
providing “pain relief with peace of mind.” Joint-Ritis ads have been airing steadily through the
fall. (“The Tan Sheet” January 3, 2005)
Quantified claims for ArginMax sexual supplements should be removed, CBBB group tells Daily
Wellness Company. Four studies submitted as substantiation for print, online ads are too small,
lack objective data-collecting instruments, ERSP says. (“The Tan Sheet” January 3, 2005)
Aleve Tied to Heart Problems
Acne is an emotionally distressing disease that can cause anger and frustration in adolescents and is
often underestimated by parents, James Campbell, MD, Dartmouth Medical School, concludes in a
study presented at the American Academy of Dermatology meeting in New York City July 28-Aug.
1. Acne affects about 85% of young adults and has more social ramifications than perhaps any
other skin disease, findings state. Study surveyed 504 acne-prone teens ages 12-17 and 500 parents
of teens 12-17 who experience occasional to severe acne. Teens with more severe acne were shown
to experience a higher level of duress and anger, while parents of these teens were less aware of their
feelings. While two-thirds of parents said they feel supportive towards their children with acne, less
than half of the children agreed. (“The Rose Sheet” August 9, 2004)
Acupuncture effective in reducing osteoarthritis symptoms, presents fewer side effects than oral
treatments, study in the Annals of Internal Medicine indicates. Improvements in pain, function
scores show the alternative treatment is also effective as an adjunctive therapy for arthritis sufferers
taking pain relieves, author suggests. (“The Tan Sheet” January 3, 2005)

Many people think the costs of prescription drugs and other health care items stand out as
exceptionally expensive, compared to other goods and services, according to a new Harris
Interactive poll. The poll report says majorities of the U.S. public think the cost of prescription
drugs, hospitals, and doctors’ services are unreasonably high, while relatively few people think
that’s true of the cost of packaged goods, clothes, and automobiles. As a result, Harris says,
majorities favor federal price controls for prescription drugs and hospital charges and a plurality
favor controls for prescription drugs and hospital charges and a plurality favor controls on doctor
bills. (FDAweb, September 10, 2004)

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Drug manufacturers’ recent pricing actions overseas may signal a new strategy to counter proposals
for reimporting drugs into the U.S., American Enterprise Institute fellow Scott Gottlieb, MD,
suggested. “The pharmaceutical companies are starting to raise their prices overseas and then
giving rebates to the foreign governments, so the list prices in certain markets are actually going
up,” Gottlieb said. Any reimportation legislation passed by Congress is likely to be “largely
meaningless” and “easily thwarted” by the market, the AID fellow says. (“The Pink Sheet”
November 15, 2004)
MEDICAL DEVICES
Regulatory Update
FDA Federal Register: Agency Information Collection Activities: Proposed Collection; Comment
Request; Medical Device Labeling Regulations.
FDA Guidance for Industry and FDA Staff: A Pilot Program to Evaluate a Proposed Globally
Harmonized Alternative for Premarket Procedures:
http://www.fda.gov/ohrms/dockets/98fr/01d-0281-gdl0003.pdf
FDA is issuing a final rule that amends its menstrual tampon labeling regulation to change the
current term for tampons that absorb 6 g and less of fluid. A tampon with this absorbency is
currently required to be labeled as “junior”. The agency is changing the term “junior” to “light”
because the term “junior” implies that the tampon is only for younger or teenage women when, in
fact, it may be appropriate for women of any age with light menstrual flow.
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-19488.htm
FDA is making available the draft guidance entitled Hospital Bed System Dimensional Guidance to
Reduce Entrapment to provide recommendations intended to reduce life-threatening entrapments
associated with hospital bed systems. It characterizes the body parts at risk for entrapment,
identifies the locations of hospital bed openings that are potential entrapment areas, and
recommends dimensional criteria for bed systems.
http://www.fda.gov/cdrh/ocer/guidance/1537.pdf
Enforcement Update
FDA Warning Letter: 7-Day Miracle Cleanse regulatory problem
FDA Warning Letter: Company Investigator failed to ensure that informed consent is obtained
from all study subjects and failed to follow the investigational plan.

Study: PDAs Don’t Interfere with Pacemakers: Researchers at the Mayo Clinic in Rochester,
Minn., reported they did not detect interference from personal digital assistants (PDAs) on cardiac
devices. The importance and reliance on wireless technology for medical purposes sparked the

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need for such a study. (“Devices & Diagnostics Letter”, January 4, 2004)

Diabetic’s suit claims overcharges for lancets at SoCal stores.
http://www.montereyherald.com/mld/montereyherald/news/10324434.htm
Kleenex to sell tissue that kills viruses
http://abcnews.go.com/wire/Living/ap20040714_2137.html
INTERNATIONAL UPDATE
Europe
Report says Prozac found in U.K. water supply
http://news.bbc.co.uk/1/hi/health/3545684.stm
Europeans reject low-carb « blasphemy »
http://seattlepi.nwsource.com/food/185406_carbs09.html
The urge to infidelity….it’s in her genes
http://www.guardian.co.uk/uk_news/story/0,,1358904,00.html
P&G withdraws baby balm from European stores
http://www.cosmeticsdesign.com/news/news-ng.asp?id=57141-p-g-withdraws
EU/ISRAEL : Agreement reached on labeling of food from occupied territories: All goods,
including processed foods and fresh produce, made in the settlements in the West Bank and the
Gaza Strip, will from now on bear a note identifying the point of origin. The EU and Israel have
signed an agreement which puts an end to the seven-year controversy regarding labelling of
products made in the territories occupied by Israel since 1967. (just-food.com)
Researchers reported at a European diabetes conference in Munich that Pfizer’s Exubera, an inhaled
form of insulin for diabetics, proved effective with no more impact on patients’ breathing ability
than oral drugs taken during a two-year experiment. The results are expected to help Pfizer and its
partners in the venture, Aventis and Nextar Therapeutics, receive regulatory approval for the first
form of insulin not administered by an injection or an invasive pump.
U.K. study finds no thimerosal link to child behavioral problems
http://news.bbc.co.uk/2/hi/uk_news/england/bristol/somerset/3632162.stm
European Cosmetic, Toiletry and Perfumery Association, working with the European Commission
and member states, has developed a Web-based central database to provide the public with access
to cosmetic company contact information. European-Cosmetics. info site will provide the public
with contact details to be used when requesting information marketers are requried to provide under
new provision in the seventh Amendment to the Cosmetics Directive, effective Sept.11. (http://
www.european-cosmetics.info/site/index.cfm?SID=14075&HOME=1) Rule permits public to ask
cosmetic companies for information regarding ingredient listings, information on certain
ingredients, and existing data on effects on human health resulting from use of the product.
Voluntary cosmetics directory will be available in any official EU language; companies will be

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expected to respond to the public within three weeks if the contact details are used, Colipa adds. (The
Rose Sheet, October 11, 2004)
European Commission rule banning cosmetics formulated with updated Category I, II, and III
ingredients, classified as carcinogenic, mutagenic or toxic to reproduction, unless evaluated by the
Scientific Committee for Consumer & Non-Food Products « SCCNFP » is published in the Official
Journal of the European Union Sept. 25. States had three months following the entry into force of the
directive to ensure that products are not marketed (the deadline was December 25, 2004), and must
make certain that products formulated with the ingredients are not sold or disposed of to the final
consumer after six months from the date of entry into force of the national provisions. Cosmetic
ingredients affected by the ban include coal tar, di-butyl-phthalate and 2-ethylhexyl phthalate. States
were to enact any laws, regulations and administrative provisions necessary to comply with the
directive by Oct. 1. The provision was included as part of the Seventh Amendment to the Cosmetics
Directive. (The Rose Sheet, October 11, 2004)
Asia/Pacific
Chinese pharmaceutical firms plan joint production of generic Viagra
http://www.inpharma.com/news/news.asp?id=1588
Ajinomoto Co. agreed to pay Masayorhi Naruse about $1.5 million for inventing an artificial
sweetener. Naruse was the former chief of the company’s research division and sued the company for
compensation related to his discovery of Aspartame in 1982. One of Naruse’s lawyers said, “This is a
major step forward, as it raises the possibility that engineers employed by companies will receive large
financial rewards for their inventions.”
http://washingtontimes.com/upi-breaking/20041120-074600-2784r.htm
JAPAN: Poultry farm boss evades jail over bird-flu cover-up: Hideaki Asada, the president of a
chicken farm at the center of the bird flu outbreak in Kyoto Prefecture, Japan, evaded jail for his part in
covering up the outbreak. Asada violated disclosure laws when he failed to report the outbreak when
it started. The judge perhaps showed lenience because it is evident that the family felt great remorse
and shame. Asada’s father committed suicide with his wife after the cover-up was exposed. The
company has closed. (just-food.com)
Japan: New Agency For Faster Drug Approval: Three major agencies responsible for drug and medical
device approval in Japan merged into one organization called the Pharmaceuticals and Medical
Devices Agency (PMDA), on April 1, 2004. Previously, the Pharmaceuticals and Medical Devices
Evaluation Center (PMDEC), Organization of Pharmaceutical Safety and Research (OPSR) and the
Japan Association for the Advancement of Medical Equipment (JAAME) were separate organizations,
all in charge of the drug and medical device approval process. The creation of the PMDA will
consolidate the work of the these three organizations and will make the drug and medical device
approval process, including managing consultations for clinical trials, product reviews of approval
and licensing applications, and side-effects monitoring, much more timely and efficient in Japan.
Akira Miyajima, the head of OPSR, believes that the new agency will put Japan on the same level as
the U.S. FDA and European Agency for the Evaluation of Medicinal Products, approving drugs in an
average of 12-16 months.

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Previously, Japan’s drug approval process could take up to 20 months. By 2009, the PMDA hopes
to approve about 80% of drugs within a 12 month period, up from the current rate of 50%.
Additionally, under the PMDA, a fast-track approval process has been initiated for all orphan drugs
and devices. Applications for fast-track approval will need to be submitted before any pre-approval
consultations can take place and will cost about 751,500 yen (US $6,900). Drugs and devices
meeting fast-track criteria – drugs or devices used to treat deadly, life-threatening diseases – will be
eligible for this expedited review and approval process. However, the new agency has a long way
to go before it reaches the same approval level as the U.S. and Europe. The agency currently has a
shortage of qualified staff and is aiming to boost its staff members from 317 to 357 employees in
the next several years. Moreover, it is possible that drug approval fees could double, increasing
fees to as much as 16 million yen (US $150,000) per drug. However, analysts say that these higher
fees will not hurt a company’s profits, as a drug will be able to hit the pharmaceutical market much
sooner with the PMDA’s speedier approval process. (Pacific Bridge, Inc., Asian Medical Newsletter,
August 2004)
Malaysia’s Ministry of Health Introduces the Traditional and Complementary Medicine Act: In
May 2004, Malaysia’s Ministry of Health announced the drafting of the Traditional and
Complementary Medicine Act. This Act will provide guidelines to better regulate traditional and
complementary medicine (TCM) practices in Malaysia by integrating them into the country’s
National Healthcare System.
The use of traditional and complementary medicine is widespread among developing nations and is
gaining popularity among developed countries. According to the World Health Organization
(WHO), approximately 66% of the population in developing countries uses TCM on a regular basis,
and about 50% of the global population in developed countries. In accordance with the TCM Act,
all TCM practitioners will be required to register with the Ministry of Health. Currently, 3,000
TCM practitioners have already voluntarily registered, even though the Traditional and
Complementary Medicine Act will not go into effect until 2006. Once the TCM Act is
implemented, registration with Malaysia’s Ministry of Health will become mandatory for all TCM
practitioners. However, registration alone will not guarantee automatic approval or endorsement by
the Ministry of Health. The practitioner will still be required to meet certain standards and many
aspects of the practitioner’s operation will be monitored, such as the products used to treat patients,
quality of the products, methods of treatment, safety, and scientific evidence showing effectiveness
of these TCM’s. A standing committee made up of representatives from the Ministry of Health,
Malaysian Medical Association (MMA), and various practitioner’s groups and universities in
Malaysia, is working to create a module which will cover the issues of TCM education,
consultation and monitoring. (Pacific Bridge, Inc., Asian Medical Newsletter, August 2004)
Indian scientists develop synthetic molecule to fight TB
http://story.news.yahoo.com/news?tmpl=story&cid=1507&ncid=1507&e=4&u=/afp/20040907/
hl_afp/india_health_tb_040907170736

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MEETINGS AND CONFERENCES
02/11/05 – 02/13/05 NHP Research Conference: Integrating Basic & Clinic British Columbia
Research on Natural Health Products Contact: Hazrah Moothoo
e-mail: Hazrah_Moothoo@bcit.ca
Phone: 604-432-8949
Website: http://www.nhpresearch.bcit.ca
02/12/05 – 02/13/05 International Complementary and Alternative Grand Hyatt Hotel

Healthcare Expo New York, New York
Contact: Diversified Business
Communications
Website: www.camexpo.com
02/25/05 – 02/26/05 The Network Journal’s Multicultural Summit on New York City, New York
Complementary Alternative Medicine Contact: Fritz-Earle Mc Lymont
Phone: 212-962-3791
e-mail: levity@optonline.com
Website: www.tnj.
03/02/05 – 03/05/04 CTFA annual meeting Boca Raton Resort and Club
Boca Raton, FL
More info: www.ctfa.org
03/18/05 – 03/20/05 Natural Products ExpoWest Anaheim, California

Organizer: New Hope Natural Products
1401 Pearl Street
Boulder CO 80302
Phone: 303-939-8440
Fax: 303-939-9559
Website: www.expowest.com
03/24/05 – 03/25/05 Assessing the Health Effects of Bioactive Food Bethesda, MD

Components Organizer: HHS, on behalf of an ad hoc
Federal working group. This conference will
focus on existing and new approaches to
assessing health effects and the suitability
of these approaches to assessing the health
effects of bioactive food components, which
are undergoing official evaluation and
definition. See also April 1 workshop
(below)
Website: http://www.scgcorp.com/
bioactivefood2005

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04/01/05 Assessing the Health Effects of Bioactive Food Components San Diego, California
Workshop on lessons learned. See March
24 conference (above).
Website: http://www.scgcorp.com/
bioactivefood2005
04/04/05 – 04/05/05 The ‘Omics’ Revolution: Emerging Scientific Lihue, Kaua’I, Hawaii
Technologies and Their Application to Dietary Supplement The future impact of genomics, proteomics
and Natural Products Research and metabolomics on natural products
research.
Website for registration and abstract
submission: http://genomics.uic.edu
Contact: Gail Mahady via email:
mahady@uic.edu
05/03/05 – 05/05/05 Consumer Specialty Prodcuts Association (CSPA) mid- Downtown Marriott
year meeting Chicago
More info: CSPA (202) 872-8110
Fax: (202) 872-8114
05/04/05 – 05/06/05 SupplySide East Baltimore Convention Center

Baltimore Maryland
Organizer: Virgo Publishing, 3300 N.
Central Avenue #2200 Phoenix, AZ 85012
Phone: 480-990-1101
Fax: 480-675-8199
Website: http://www.supplysideshow.com/
east/
05/06/05 – 05/08/05 AOMAlliance 12th Annual Conference & Expo Hyatt Regency on Goat Island
Newport, Rhode Island
Website: www.aomalliance.org
Phone: 800-814-5956
06/02/05 – 06/03/05 SCC scientific seminar Mandalay Bay Resort and Casino
Las Vegas, NV
More info: (212) 668-1500
07/15/05 – 07/17/05 NNFA 68th Annual Natural Products Convention and Trade Sands Expo & Convention Center
Show Las Vegas, Nevada
Organizer: NNFA (National Nutritional
Foods Association), 3931 MacArthur Blvd,
Suite 101, Newport Beach, CA 92660-3013
Phone: 949-622-6272/800-966-6632
Fax: 949-622-6266
Website: www.nnfa.org
09/09/05 – 09/10/05 International Aloe Science Council’s 24th Annual Seminar Sheraton Fiesta South Padre Island Beach
Resort
e-mail: iasc1@msn.com
Website: www.iasc.org

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14 for hard copies.
www.klng.com
09/15/05 – 09/18/05 Natural Products ExpoEast Washington, DC
Organizer: New Hope Natural Products,
1401 Pearl Street, Boulder, CO 80302
Phone: 303-939-8440
Fax: 303-939-9559
Website: www.expoeast.com
09/19/05 – 09/21/05 IFSCC international conference Florence, Italy

More info: (44) 1582-726661
Fax: (44) 1582-405217
Website: www.ifscc.org
10/12/05 – 10/17/05 Third International Medicinal Mushroom Conference Fort Worden Conference Center in Port
Townsend, WA
Website: http://www.fungi.com/immc/
index.html
11/09/05 – 11/11/05 SupplySide West The Venetian and The Sands Expo, Las
Vegas, NV
Organizer: Virgo Publishing, 3300 N.
Central Avenue #2200, Phoenix, AZ 85012
Phone: 480-990-1101
Fax: 480-675-8199
Website: http://
www.supplysideshow.com/west/

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Kirkpatrick & Lockhart’s Food and Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food, Drug, and Cosmetic Act. We represent manufacturers
and distributors of food, dietary supplements, pharmaceuticals, medical devices,
biologicals and personal care and cosmetic products. Areas of experience include
enforcement, approvals and clearance, labeling and advertising, clinical research,
inspections and import/export.
PARTNERS
Gary L. Yingling 202.778.9124 gyingling@kl.com
Suzan Onel 202.778.9134 sonel@kl.com
OF COUNSEL
Emalee G. Murphy 202.778.9428 emalee.murphy@kl.com
ASSOCIATES
Ann M. Begley 202.778.9365 abegley@kl.com
Kenneth J. Borgerding 202.778.9412 kborgerding@kl.com
Rebecca L. Dandeker 202.778.9409 rdandeker@kl.com
Joshua S. Kim 202.778.9039 jkim@kl.com
Anthony T. Pavel, Jr. 202.778.9089 apavel@kl.com
BOSTON DALLAS HARRISBURG LONDON LOS ANGELES MIAMI NEWARK NEW YORK PITTSBURGH SAN FRANCISCO WASHINGTON
.........................................................................................................................................................
This publication/newsletter is for informational purposes and does not contain or convey legal advice. The information herein
should not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer.
16
© 2005 KIRKPATRICK & LOCKHART LLP. ALL RIGHTS RESERVED.

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FOOD & DRUG PRACTICE

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02/12/05 – 02/13/05 International Complementary and Alternative Grand Hyatt Hotel

03/18/05 – 03/20/05 Natural Products ExpoWest Anaheim, California

03/24/05 – 03/25/05 Assessing the Health Effects of Bioactive Food Bethesda, MD

If you have difficulty

05/04/05 – 05/06/05 SupplySide East Baltimore Convention Center

If you have difficulty

09/19/05 – 09/21/05 IFSCC international conference Florence, Italy

If you have difficulty

regulatory counseling to companies and other organizations regulated by FDA

and distributors of food, dietary supplements, pharmaceuticals, medical devices,

enforcement, approvals and clearance, labeling and advertising, clinical research,

inspections and import/export.

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