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Articles from 2003 In October


Delicious Living

November 1, 2003

Bioterrorism Act Gets Ready To Bite

United States

More than a year after it was enacted, the US Public Health Security and Bioterrorism Preparedness and Response Act of 2002 will become fully functional on December 12, after which all foodstuffs and dietary supplements entering the US must meet Food and Drug Administration requirements or risk quarantine.

Conceived in the wake of September 11, it is estimated the new law will affect more than 400,000 US and international businesses in the food and supplements industry, although uncertainty about its operation mean its direct and indirect cost to industry has not been ascertained. It requires, among other things, the registration of domestic and foreign food facilities that manufacture, process, pack, transport, distribute, receive, hold or import food or food supplements for human or animal consumption.

"These are very serious rules and the FDA is very serious about enforcing them. It?s crunch time," said the US-based National Nutritional Foods Association?s director of legislative affairs, Kim Smith. She was confident the laws would not be over-burdensome if companies acted quickly and studiously. "US companies should communicate with their international partners to make sure they are up to speed on this."

More info:

www.nnfa.org/services/government/bioterror.htm

http://www.fda.gov/oc/bioterrorism/bioact.html

Loren Israelson, president of LDI Group, a consultancy to the dietary supplements industry, was less optimistic. "At least seven government authorities have co-authority on this. The Customs Service, Postal Service, USDA, and FDA, among others. Are they going to be able to co-ordinate? It doesn?t look like it. You may get an enquiry on the same shipment from five government agencies. That?s a burden."

The UK-based Food and Drink Federation expressed similar concerns. "We are not quite sure if the new Act and existing customs regulations are going to be compatible," said its press officer, Kate Snowden. "The registration process may be low cost but if goods are held up there are likely to be significant costs and we want to make sure this does not happen without proper justification and transparency."

Israelson advised US companies to be prepared for interruptions in supply. "You might want to inventory a little more heavily before the law kicks in, in case your goods get held up or a container load of goods carrying your stock gets held up," he said. "The FDA has X-ray machines that can scan whole containers at once. If you?re dealing in botanicals, for example, you might want to consider the way they are being shipped as this kind of treatment may damage your goods." He added: "Companies will have to work closely with their suppliers to ensure there are no reasons for FDA to assert their new and broadened definition of adulteration against incoming foods and dietary ingredients."

Be Energy-Wise

Act Up

Be Energy-Wise

As cooler weather approaches, how can you save energy and help reduce gases that contribute to global warming and other environmental problems? Use these four tips from Earth Share, a nationwide network of America’s leading nonprofit environmental and conservation organizations.

1. Inspect your heater. Have a professional inspect and clean your furnace and ducts. Replace old filters on forced-air furnaces.

2. Buy a programmable thermostat. If you turn your thermostat back by 10 percent to 15 percent for eight hours every day or night, you can save as much as 10 percent a year on your heating bill.

3. Check your insulation. You can reduce heating and cooling needs up to 30 percent simply by investing in insulation and like-minded products.

4. Treat your windows right. Prevent heat loss by closing your curtains and shades at night; open them during the day to benefit from free solar heat. Also, keep windows on the south side of your house clean to maximize the amount of sunlight coming in.

Source: Earth Share (www.earthshare.org).




Take These For Immune-System Balance

Herb/Supplement

Amount To Take

How It Works

Comments

Astragalus (Astragalus membranaceus)

3–5 ml of tincture three times per day.

Polysaccharides (complex sugar molecules) in this herb enhance the activity of certain immune system cells, including white blood cells.

This herb also can be taken daily as a decoction, by boiling approximately 10 grams of the root in water for five minutes, then drinking as a tea.

Eleuthero (Eleutherococcus senticosus)

Take 2–3 grams of dried, powdered root and rhizomes daily. Or take 300–400 mg of concentrated solid extract standardized to eleutherosides B and E daily. Another option is 8–10 ml of an alcohol-based extract taken a few times a day.

Polysaccharides and compounds called eleutherosides support immune function; this herb also supports healthy adrenal glands to counteract the effects of stress.

Side effects are uncommon but can include diarrhea and insomnia. Traditionally, two-week breaks are recommended for every two months of daily eleuthero use.

Garlic(Allium sativum)

About one raw clove per day, or chop and add to the end of the cooking process. Another option is tablet or capsule form; follow label directions.

Garlic increases resistance to disease by stimulating the immune system, including white blood cells, natural killer cells, and phagocytes; it has a direct antimicrobial effect by inhibiting growth of bacteria, viruses, and fungi.

Garlic is very safe to use, although a few people experience heartburn or flatulence.

Mushrooms: cordyceps (Cordyceps sinensis), maitake (Grifola frondosa), reishi (Ganoderma lucidum), and shiitake (Lentinus edodes)

Whole, dried mushrooms can be included in cooking. Alternatively, 2–4 ml of tincture can be taken daily in tablet or capsule form; follow label directions.

Polysaccharides primarily account for immune-enhancing effects.

Adverse effects with mushrooms are unlikely, but reishi and cordyceps have been occasionally reported to cause dizziness, dry mouth, and upset stomach; shiitake in high doses has in a few cases been linked to diarrhea.

Probiotics

Active-culture yogurt can be eaten as part of the diet. Alternatively, capsules, powders, and liquids are available and generally taken in the amount of 1–2 billion colony-forming units (CFUs) per day.

Probiotics inhibit the growth of bacteria, produce natural substances that kill infectious microorganisms, colonize the gut with a healthy balance of intestinal flora, and enhance the activity of several immune system cells.

Probiotics need to be consumed at least a few times a week to be beneficial. Generally well-tolerated, though reactions include flatulence and constipation.

Sterols/sterolins

60 mg per day.

Sterols and sterolins act on specific white blood cells in the immune system called lymphocytes to ensure the proper balance in the body.

For maximum absorption, take at least 45 minutes before a meal or two hours after a meal. Diabetics should monitor their blood sugar and adapt their insulin level as needed because sterols and sterolins can lower blood sugar levels.

—V.D.T


Your Postpartum Pantry

Your Postpartum Pantry

What You Need

Nutrients

Have On Hand

Dairy

Calcium, protein.

Low-fat milk, yogurt or kefir, single-serve puddings, low-fat cheese, cottage cheese.

Small meals

B vitamins, iron, protein, vitamin C.

Turkey or chicken breast, steak, canned white tuna or salmon, eggs (protein, iron, B vitamins); canned beans (protein, folate, iron); sweet potatoes, precut vegetables, frozen broccoli and cauliflower, canned roasted red peppers, canned tomatoes, tomato sauce (vitamin C).

Snacks

Folate, iron, protein, vitamin C.

Peanut butter (protein, folate); edamame (protein, iron, folate); nuts and sunflower seeds (protein); red pepper slices, grape tomatoes, oranges, grapefruits, berries, kiwis (vitamin C).

Whole grains

B vitamins.

Fiber-rich cereal, whole-wheat bread and crackers, instant oatmeal, whole-grain toaster waffles.



Cyanotech Corporation Reports Second Quarter Fiscal 2004 Financial Results; Company Reports Quarter to Quarter Sales Increase of 17%

KAILUA KONA, Hawaii, Oct 30, 2003 (BUSINESS WIRE) -- Cyanotech Corporation (Nasdaq:CYAN), a world leader in producing high-value natural products from microalgae, today announced financial results for the second quarter of fiscal year 2004, ended September 30, 2003, demonstrating continuing improvement from the prior quarter's results.

For the second quarter of fiscal 2004, net sales were $2,840,000, a 17% increase from the $2,428,000 recorded for the prior quarter and a 41% increase from the $2,018,000 recorded for the comparable quarter of the prior fiscal year. The increase in sales, quarter to quarter, was due primarily to increased bulk sales of the Company's natural astaxanthin products, NatuRose(R) and BioAstin(R), and higher sales of packaged consumer products. The growth in natural astaxanthin product sales was especially evident in the Company's subsidiary in Japan, with a 91% increase in sales over the prior quarter. For the first six months of fiscal 2004, net sales were $5,268,000, an increase of 30% from the $4,050,000 recorded for the comparable period of fiscal 2003. The Company's gross profit margin percentage for the quarter ended September 30, 2003 was 30%, a slight increase over both the prior quarter and the comparable quarter of the prior fiscal year.

During the quarter ended September 30, 2003, operating expenses increased by $75,000 over the previous quarter amount; however, compared to the three months ended September 30, 2002, operating expenses for the current fiscal quarter decreased by $173,000. Operating expenses for the first six months of fiscal 2004 decreased by $643,000 from the comparable period of the prior fiscal year. For the quarter ended September 30, 2003, the Company recorded income from operations of $32,000 in contrast to the loss from operations of $434,000 in the comparable prior fiscal year period.

Net loss for the quarter was $10,000, or ($0.00) per diluted share, an improvement over the net loss of $141,000, or ($0.01) per diluted share, reported for the prior quarter, and the net loss of $540,000, or ($0.03) per diluted share, reported for the comparable quarter of the prior fiscal year. On a fiscal year-to-date basis, the net loss for the first six months of fiscal 2004 amounted to $151,000 or ($0.01) per diluted share compared to a net loss of $1,325,000, or ($0.08) per diluted share reported for the comparable period of the prior fiscal year.

Cash balances at September 30, 2003 were $1,193,000, up from $681,000 and $579,000 reported at June 30 and March 31, 2003, respectively. Cash generated from operations during the current second quarter increased $155,000 over the previous quarter results. The Company's increased cash balances, offset in part by higher current liabilities, resulted in an improvement in working capital of $485,000 during the second quarter of fiscal 2004.

"Our increased sales for the quarter ended September 30, 2003, combined with our management of costs, demonstrate Cyanotech's continuing focus on achieving profitability," said Gerald R. Cysewski, Ph.D., Chairman, President and Chief Executive Officer. Elaborating on the Company's increased sales, Dr. Cysewski commented, "As the first manufacturer to commercialize natural astaxanthin from microalgae, we are pleased with the increased growth in sales of our NatuRose products for the animal nutrition market and our BioAstin products for the human nutrition market. We continue to see strong demand for our NatuRose products in Japan and are also experiencing increased sales of our BioAstin products in the United States and Europe."

Dr. Cysewski noted that Cyanotech's Quality Management System has been granted registration under the new ISO 9001:2000 standard, well in advance of the December 31, 2003 deadline, reaffirming the Company's commitment to quality. "We are justifiably proud of this achievement. Certification under the new ISO standard not only confirms Cyanotech's role as an internationally recognized manufacturer of high-quality natural products, but is a testament to the dedication of our personnel and the continued excellence of the Company's operations and products."

About Cyanotech

Cyanotech Corporation, a world leader in microalgal technology, produces high-value natural products from microalgae and is the world's largest commercial producer of natural astaxanthin (pronounced "asta-zan-thin") from microalgae. Products include BioAstin(R) natural astaxanthin, a powerful antioxidant with expanding applications as a human nutraceutical; NatuRose(R) natural astaxanthin for the aquaculture and animal feed industries; Spirulina Pacifica(R), a nutrient-rich dietary supplement; and phycobiliproteins, which are fluorescent pigments used in the immunological diagnostics market. Spirulina Pacifica and BioAstin are sold directly online through the Company's website, www.nutrex-hawaii.com, as well as through resellers in over 30 countries worldwide. Technical information for the Company's phycobiliproteins products is available at www.phycobiliprotein.com. Corporate data and other product information are available at www.cyanotech.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

Except for statements of historical fact, the statements in this press release are forward-looking. Such statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include, but are not limited to, general economic conditions, forecasts of sales in future periods, changes in sales levels to our largest customers, weather patterns, risks associated with the acceptance of new products, competition, foreign exchange fluctuations, government regulation, and other factors more fully detailed in the Company's recent Form 10-Q and annual form 10-K filings with the Securities and Exchange Commission.

Editorial: Industry's Eight Fears This Halloween

By Len Monheit
[email protected]
Comment on this Editorial

While in general I remain quite confident that companies who take the proper steps and measures will be successful in the future, I cannot deny that there are many vulnerable issues for the dietary supplements industry. Whether you’re operating in the US, Canada, Australia or even the European market regulatory uncertainty is going to have an impact. And of course, we’re not an isolated industry. We’re impacted by economic and trade factors, and our customers and legislators (as we know all too well) are heavily influenced by media and their own fundamental beliefs and perceptions.

With this (and Halloween) as background, I’d like to take this opportunity to list some of the scary issues we face. This is my list, and I’d certainly like to encourage others to share theirs with us:

  1. Education

    I fear that the gap between product development and the science to support products is increasingly being filled by marketing alone. This means that customers baseline understanding is not growing. In this instance, I define customers as anyone along the value chain who plays a role in the buying and selling process and take care to include legislators, practitioners, consumers and media. Critically, there is a lack of ownership of fundamental responsibility that needs to be addressed. Who is going to do the education?

  2. Short term mentality all too often prevails

    In uncertain economic times, companies need to ensure the bottom line remains stable. This often leads to a cycle of thinking only through the next few quarters with more strategic projects forgotten. These typically include product development and enhancement, category development (as opposed to product development) and strategic project positioning (a part of which is clinical research and value chain education). This way of thinking also means that price becomes the most important selling tool, and product and company differentiation ceases to be important.

  3. We have an image problem

    As a sector, the image we project influences the way we are treated. If we determine, as an industry, that working with practitioners and the scientific community is critical to future success and more widespread adoption of our products and our science, then we must project an image that is credible, stable, in control of itself and all of its members and their actions. Until we have consensus on this issue, it will be difficult for the industry to reach the expanded consumer base it must interact with in order to reach all potential markets.

  4. Lack of clear, empowered decisive leadership

    Notwithstanding the efforts of industry trade associations in all geographic regions (US, Canada, Australia etc.), recognized business leaders are few and far between. In many of these regions, industry could immensely benefit by having available, as spokespersons and resources, recognizable individuals with a solid business background, charismatic leaders capable of interacting with media, dealing with economic analysts, motivating employees and industry stakeholders, and thinking clearly and operating capably on both strategic and operational levels.

  5. No barriers to entry fundamentally exist

    This issue is really one of the industry’s double edged swords. Built primarily by entrepreneurs, the sector has succeeded due to the passion, commitment and creativity of these pioneers and more recently, by those who have used this commitment, and traditional and natural products, as the source of their innovation. Many observe the relative lack of barriers in this sector, especially when they consider other sectors. Sure, there are requirements, regulations and guidelines which must be met, including GMP’s, advertising and labeling rules and regulatory notifications. But if you have enough money or reach, you can introduce and market a product, for a time anyway, that will justify your investment and pay a high rate of return, even if you know you’re going to face fines or legal action on the other end. (Case in point – Coral calcium)

  6. Time and cost effect of new regulatory environment

    Earlier this week, the Australian Department of Health published a review of the complementary medicines sector and regulation, triggered by the Pan Pharmaceutical quality practice investigation earlier this year. The recommendations, even if implemented in part, will impact suppliers and manufacturers, undoubtedly adding a cost burden to operations.

    Similarly, changes in Canada and the US either being discussed or in various stages of implementation will change industry economics, likely adding to the price of finished products to consumers, also creating an administrative burden for the companies themselves. Whether it’s the product licensing process in Canada or testing requirements in Canada, the US or Australia, or even changes in label requirements anywhere in the world, understanding, implementing and paying for these ‘rule’ changes will be a burden. If there’s a cost involved and all the squeezing has been done out of the value chain (that’s a separate issue), then the consumer must pay. Without an additional value proposition, some won’t and growth will be severely restricted.

  7. You can’t get ahead if you’re on defense all the time

    The industry repeatedly attempts to defend itself against attacks coming from many directions including media, the medical community, and legislators. While tying up precious resources, it also, predictably, prevents any offensive thrust or strategy for the industry as a whole. Companies, operating singly or even in small groups, have been successful and proactive, with omega-3 products and suppliers being the most recent example of the successful expansion of a category, and more of this type of effort is required.

  8. Uncertain economic model for investment in science

    Just how valuable is the science? Often, useless for the company investing in it, while valuable to competitors and knock-offs and marketers who take data and mold it into a compelling marketing message often bearing little resemblance to the original data and parameters. Fundamentally and long term – the science is quite valuable, but in the short term, it ties up scarce resources and has uncertain returns so the risk benefit assessment may not justify the investigation. Many have spoken about the liberal borrowing of science, and a few months ago, the seriousness of this issue was struck home at an American Herbal Products Association presentation with FTC where the FTC representative was asked by an AHPA member how they were going to enforce advertising where a proprietary product (standardized herbal with proprietary process) had specifically been studied with health benefits to support health claims the company planned to make available to users of this specific ingredient. The question to FTC was, ‘Are they (FTC) going to take enforcement action against other companies making the same claim and how are they going to evaluate the product differences?’ FTC apparently didn’t understand the issue.

The industry has character, a grass roots appeal, an emerging spectrum of science (or the funding resources to generate such science) and most importantly, a potential significant benefit to health. Realizing and overcoming one’s fears is the surest way to succeed.

Happy Halloween.

Another World Is Happening! See It In Action: SF Green Festival Nov. 8 and 9

Trying to find ecologically sound products in the local supermarket?
Wondering how you can make sure that the lumber used to remodel that kitchen or bathroom is not old growth wood? Interested in changing the world by investing in an alternative economy where the bottom line is not the only line?

The San Francisco Green Festival, opening at the San Francisco Concourse Nov. 8 and 9, is where you will find the answers to these and many other questions. A non-profit project, sponsored by Global Exchange and Co-op America, the Green Festival will be open Saturday from 10 am till 9 pm and Sunday from 11 am to 7 pm. Tickets are $15 at the door.

There is an alternative to an American economy mired in waste, greed and environmental degradation‹and the San Francisco Green Festival is where you will find it all in one place. Visit 300 exhibits covering green technology, renewable energy, eco-fashion, green finances, Fair Trade and more. Fifty speakers will address the festival, including Alice Walker, Greg Palast, Arianna Huffington, Jim Hightower, Eleanor Smeal, and Medea Benjamin.

The Green Festival is another indication that Americans are concerned about the environmental and social impact of their spending. They want to buy products, purchase services and build homes that protect the environment and promote economic justice, instead of contributing to global inequality and environmental destruction. Wouldn¹t it be wonderful if your daily cup of java helped a coffee farmer¹s family, instead of pushing them into debt and despair?

Author Alice Walker put it this way: ³The Green Festival is designed to accelerate the paradigm shift from money values to life values and give a definitive answer to the question, ŒCan we save humanity from itself?¹²

The numbers speak volumes. Fair Trade sales in the United States, Canada and the Pacific Rim alone hit $250.6 million in 2002. That represents a growth rate of 37% in just one year! Fair Trade coffee sales are expanding rapidly as traditional coffee sales stagnate. Socially responsible investments now stand at $2.24 trillion, that is $1 of every 8$ invested according to a recent Trends in Social Investing report. Organic farming is expected to top
$11 billion this year, and is growing more rapidly than chemical farming.

The first two Green Festivals provide proof of the burgeoning interest in a green and fair economy. Over 10,000 people attended showed up in Austin on Oct. 11 and 12, while last year¹s San Francisco Festival attracted13,000 people, who networked madly, chowed down on organic goodies and went home happy. This year¹s event is on track to be just as successful.

For more information: www.greenfestivals.org

###

Senate Committee on Commerce, Science and Transportation Discusses Supplements

Earlier this week, the U.S. Senate Committee on Commerce, Science and Transportation held hearings regarding availability of dietary supplements, the marketing practices of the industry and the effectiveness of DSHEA (Dietary Supplement Health and Education Act) to protect consumers.

Chairman of the committee Senator McCain (R-AZ), presiding over the hearing, called a witness list which included representatives from FDA, FTC, the United States Anti-Doping Agency, David Seckman from the NNFA (National Nutritional Foods Association), Dr. Arthur Grollman, Distinguished Professor, Pharmacological Sciences and Medicine, State University of New York at Stony Brook and Mr. Charles Bell of the consumers Union.

In his introductory remarks, the Chairman noted that supplements are often promoted with questionable marketing practices and focused on potential adverse health risks. He observed that DSHEA had been effective in reducing unneccessary regulatory burden on supplements but may at the same time, have provided a safe haven for substances with health risks.

Specifically referred to were heavy use of supplements among teenagers and school sports teams and the fact that steroid precursors 'interfere with normal growth and bone development, cause hormonal imbalances, liver and kidney damage, and an increased risk of certain types of cancer.' Chairman McCain noted that he feared a health care crisis in the future due to current supplement use.

Mr. John M. Taylor, testifying on behalf of the FDA, commented on current enforcement issues and programs in concert with FTC, and Mr. Howard Beales, Director of the Bureau of Consumer Protection, Federal Trade Commission observed that 'unfounded or exaggerated claims for dietary supplements have proliferated.' He listed weight loss advertising and Internet health scams specifically, and noted the voluntary compliance to his enforcement actions, as well as the dietary supplement industry response (through the trade associations' support and impact through strong public pronouncements) against unfounded claims.

Speaking about weight loss advertising, Mr. Taylor also observed that even the most active enforcement would not totally clean up the deception, and suggested other approaches and measures might be required.

Mr. Seckman, Executive Director and CEO of NNFA, described enforcement and regulatory powers under DSHEA and noted that the 'law has never been fully implemented or adequately enforced', specifically listing GMP's, FDA's lack of response on performance enhancing products, ephedra and adverse event data. He urged the commission to 'Stop seeking legislative solutions to regulatory problems when it comes to DSHEA. Changing DSHEA to give the FDA increased authority when it has not fully applied its current powers will simply perpetuate the current situation. '

Dr. Grollman dealt specifically with safety and toxicology focusing on the lack of standardization, adulteration, herb-drug interactions, and a lack of adverse event reporting.
He observed that 'consumers are provided with more information about the composition and nutritional value of a loaf of bread than about the ingredients and potential hazards of botanical medicines.' Citing adverse event data and several 'reviews', Dr. Grollman used the ephedra example to illustrate how DSHEA hindered FDA and suggested several recommendations, including urging support for Bill S.722.

Mr. Bell commented that his concerns included the fact that new dietary supplement products can be introduced overnight that contain novel, untested ingredients and obseerved that manufacturers have suppressed safety information, DSHEA contains loopholes which allow for marketing of products such as steroid 'equivalents' and concluded that post-marketing surveillance is inadequate and ephedra should be banned.

Government Moves To Restore Confidence In Complementary Medicines Industry

A high level review of herbal and other complementary medicines in Australia, commissioned by Parliamentary Secretary for Health, Trish Worth, has called for extensive reforms to restore confidence in the alternative medicines sector and protect consumers from potentially unsafe products.

The review was conducted by a specially convened Expert Committee on Complementary Medicines in the Health System and was chaired by Dr Michael Bollen AM, a former member of the National Health and Medical Research Council and Australian Pharmaceutical Advisory Council.

The committee of 18 experts comprising representatives of the complementary medicines industry along with academics and clinicians, focused on issues around the supply of safe, high quality complementary medicines, quality use of and timely access to these medicines, and the maintenance of a responsible and viable complementary medicines industry.

The review also looked closely at the role of the national regulator of complementary medicines, the Therapeutic Goods Administration (TGA).

One of the major recommendations of the committee compels the TGA to ensure that quality standards for all ingredients for use in complementary medicines are legally enforceable and that the evidence required to be held by companies (sponsors) to substantiate claims be subject to much more rigorous assessment.

The review recommends that homoeopathic medicines and related remedies making therapeutic claims also be regulated to ensure they meet appropriate standards of safety, quality and efficacy.

The Committee recommends that the government take a more active role in ensuring that consumers have access to reliable information about complementary medicines, and the skills to interpret this information to be able to make informed decisions.

The review makes a number of recommendations to counter adverse reactions to complementary medicines, including creating a greater awareness among all health professionals and consumers of the potential for complementary medicines to interact with other medicines, and ensuring consumers are better informed about the potential risk of importing medicines for personal use.

The review calls on states and territory governments to introduce legislation to regulate practitioners of traditional Chinese medicine and dispensers of Chinese herbs, based on existing Victorian legislation as soon as possible.

It also recommends that internet advertising be considered part of mainstream advertising and be subject to mainstream advertising requirements and protocols, including complaint resolution through a centralised complaints and appeals process.

The review makes a number of recommendations about improving the level of research and funding available for complementary medicines and calls on the National Health and Medical Research Council to convene an Expert Working Group to identify the research needs, including issues around safety, efficacy and capacity building.

Ms Worth said she was impressed with the depth and thoroughness of the Review and thanked the committee for its efforts.

"In 2000 it was estimated that 52 per cent of Australians used at least one non-medically prescribed complementary medicine and 23 per cent consulted at least one complementary medicine practitioner," Ms Worth said.

"This industry is estimated to be worth $800 million, so it is vital that Australians feel confident in the industry and its products.

"The review points out that, unlike medical practitioners who need to be registered, most practitioners of complementary medicines do not have to meet such standards.

"I will be urging my counterparts in the states and territories to introduce nationally consistent regulations to licence practitioners of complementary medicines. It will go a long way towards maintaining consumer confidence.

"I am also expecting that the implementation of many of the recommendations in the review will ensure that complementary medicines are assessed more rigorously by the TGA and that companies are compelled to adhere to best practice standards."

Ms Worth said the Australian Government would move to strengthen the powers of the TGA to ensure that action would be taken immediately against any manufacturer who is not fully complying with the highest standards of Good Manufacturing Practice. This should avoid another incident like the recall of products from Pan Pharmaceuticals.

"I intend to consult widely on the Committee’s findings and recommendations to help inform the Government’s response to the report," Ms Worth said.

"I will be sending copies of the report to more than 80 stakeholder groups, including members of the complementary medicine industry, practitioner and consumer groups, seeking their comments on the Committee’s report by the end of January 2004. In addition, a copy of the report will be available on the TGA’s web site inviting comment from interested groups or individuals.

"I will then be in a position to bring forward an informed response to the Committee’s report for consideration by the Government."

A copy of the Committee’s Report – Complementary medicines in the Australian health system – is available on the TGA’s web site at http://www.tga.gov.au/docs/html/cmreport.htm