Thursday, June 28, 2007

06/28/07 - Randomized Clinical Trials; cGMPs posted


1. RCT (Randomized Clinical Trials) and nutrients
2. New cGMPs now available on net
4. CRUSH media release: Silver Safety Standard

1. RCT (Randomized Clinical Trials) and Nutrients

This article by Dr. Melton is cogent and worth reading. The article goes to the heart of the coming cGMPs – how will you substantiate the claims you make about your products? How will you prove the identity and quality of the ingredients? If you have the time to think about what your company will be doing in two years when the cGMPs become effective for small companies, this is something you need to think about… and, yes, you do need to start thinking now…

Clinical trials - gold standard or white elephant?

25/06/2007 - Randomised clinical trials are the ultimate. Forget what the observational studies tell us, if the RCT gives us an answer it must be the final word, right? Wrong.

The value of such trials for the food industry is undeniable, but too often nutrients are pulled out of context, following the same methodology as used for the testing of drugs.

But let's not forget that by following the drug model we are supplementing the diet with one or two nutrients, each at a single dose, for a set period of time. Can a time-constrained randomised trial really capture a lifetime of consumption with respect to chronic disease?

Randomised clinical trials work by randomly assigning a group of volunteers to receive an active compound, be it a drug or nutrient(s), or a non-active comparison, be it an inactive form of the active compound or a placebo. Observational studies, as the name suggests, observe a population and relate dietary intakes of food and nutrients to the occurrence of disease.

We need to consider the science as a whole and not blinker ourselves with results of one big clinical trial, regardless of how much money it costs and what universities were involved.

For food items that do not normally form part of the usual food chain, randomised clinical trials are the best of the best because such compounds can be tested and retested successfully.

Phytosterols, probiotics, or botanical supplements, for example, fit into this category.
Indeed, clinical trials on phytosterols have shown time and again that daily consumption of 1.5 to 3 grams of phytosterols/-stanols can reduce total cholesterol levels by eight to 17 per cent, representing a significant reduction in the risk of cardiovascular disease.

Studies looking at how these results transfer into real free-living populations have backed up the clinical trials, showing a stabilisation of cholesterol levels in certain populations.

So we know the benefit of clinical trials. But when we start using this approach for vitamins, minerals, antioxidants and other nutrients, we come a little unstuck.

Some may say that I'm over-reacting, but let's just look at the report published in the New Scientist magazine that slammed antioxidant supplements as myth.

Despite a vast body of observational/ epidemiological studies linking an increased dietary intake of antioxidants from fruits and vegetables to reduced risks of a range of disease, including cancer, cardiovascular disease and diabetes, when such antioxidants have been extracted and put into supplements, the results, according to RCTs, do not produce the same benefits and may even be harmful.

So the author of the article, Dr. Lisa Melton from the London-based registered charity, the Novartis Foundation, concluded that antioxidant supplements are too good to be true.

Is this really the answer or is it due to poor study design? Would a two-year trial of vitamin E, let's say, really produce a reduction in the risk of a chronic disease?

To illustrate this point further, we only need to go back to last year's Women's Health Initiative (WHI) trial that followed 18,176 post-menopausal women taking calcium (1000 mg) and vitamin D (400 IU) supplements. A similar population (N=18,106) was given a placebo. The subjects were followed for about seven years and the researchers reported that the supplements 'had no effect' on the risk of colorectal cancer.

None of the women had the cancer at the start of the study and colorectal cancer has a long latency period of 10 to 20 years, which begs the question - could we really have expected to see an effect?

We also need to remember that nutrients often work in synergy with one another and exert effects on multiple body tissues, unlike pharmaceuticals.

Additionally, many randomised clinical trials look at the effect of nutrients in diseased populations. Surely the damage of a lifetime's poor nutrition has already been done. When we obtain negative or null results from such trials, should we really be surprised?

The power of nutrients is in the prevention, not cure, of disease.

So what should we do? I don't pretend to have any answers. These are for ladies and gentlemen with infinitely bigger brains than me.

Realistically, there are no viable alternatives out there at present. Randomisation is the best way of limiting bias that creeps into every study, and controlling, specifically with placebo, is the best way to make comparisons.

For those times where randomised trials clearly aren't the best option, then we probably need to look at the observational studies and mechanistic studies in greater depth, and place more value on them.

The research community as a whole must work together to re-evaluate how to get the most from research into nutrition. Lots of different types of studies are out there. Let's make the most of what we already have.

Stephen Daniells is the Food Science Reporter for and He has a PhD in Chemistry from Queen's University Belfast and has worked in research in the Netherlands and France.

If you would like to comment on this article please contact stephen.daniells'at'


2. FDA publishes Current Good Manufacturing Practices for Dietary Supplements

I’m reading them, but so can you, at: (467 pages when downloaded to MS Word; the actual rule doesn’t start until page 426, after 359 comments…).

Here are some comments by FDA, from the commentary preceding the new rule, that tell us a lot about where the present administration of FDA is taking us: “…we disagree with the comments asserting dietary supplements have a track record of safety such that dietary supplement CGMP requirements are unnecessary. Section 402(g) of the act does not require us to establish a ‘bad’ track record of safety in the manufacture of dietary supplements before we may issue a dietary supplement CGMP rule. Furthermore, we disagree with the comments comparing dietary supplement safety to drug safety; there are different statutory requirements, different regulatory requirements, and different safety evaluations for dietary supplements and drugs.”

We can hope there will be a change of Agency attitude when the Administration changes in about a year and a half; especially if the good doctor from Texas replaces the current Texan occupying the White House. I’ll provide more tidbits as I read the materials.


3. Health Freedom Blog

The Vitamin Lawyer Health Freedom Blog is now at The address is:

I just posted a link there to an 8 minute presentation I taped for Natural Solutions Foundation, for use with health-friendly delegates at next week’s Codex Commission meeting in Rome.


4. CRUSH Silver Safety Standard

The Committee on the Responsible Use of Silver in Health (of which I am a member) is releasing the final version of its Silver Safety Standard (The “12 for 25 Rule). The media release will be posted on PRWeb shortly and can be seen at or on my Blog.

Saturday, June 23, 2007

06/23/07 - cGMP Rule issued; ingredient testing...


1. cGMP “Final Rule” Issued: all ingredients to be tested within 3 years!
2. Vitamin Lawyer starts Health Freedom Blog at
-------------------------------------------------------- Index

1. Excerpts from the FDA announcement follows. The terminology is fairly much what I had predicted in previous postings, focusing on “identity, purity, strength, and composition” – however, the enforcement procedures seem more extreme than had been predicted from the draft rule and may represent a further ratcheting of enforcement in general.

Announcement: “The U.S. Food and Drug Administration today (06/22/07) announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled. ***

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints. ***

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling. ***

FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing … if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. ***

The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with … less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

It is certainly time to make sure your Standard Operating Procedures meet the new standards, as those standards become effective. I will continue to monitor this situation and inform this email list as modified SOP documents are ready.


2. Health Freedom Blog Upgraded

The Vitamin Lawyer has just started a Health Freedom Blog at The address is: – the earliest postings from my original health freedom blog at have been reorganized to start the replacement Blogspot blog. Additional material is added as available.

Thursday, June 7, 2007

06/07/07 - Summer of Decisions; Define your Market


1. Summer of Decision “Not Unreasonable…”
2. Entire Web: Define Your Target Market

1. A Summer of Decision: Suggested Amendments to FDA "Revitalization" bill - "Not Unreasonable"

This is a summer of significant decisions in the Dietary Supplement and Natural Products marketplace.

Take Action: Natural Solutions:

From Wellness Resources: "The Senate has recently passed bill S.1082, commonly known as the FDA Revitalization Act. ...the legislation, as currently written, opens the door for considerable regulatory confusion enabling the FDA to use this legislation to undermine my access to safe and effective dietary supplements. There must be no confusing the safety of drugs and the safety of food and food ingredients – which are governed by different laws. ...members of Congress are not intending to create such concern among the 150 million Americans who rely on dietary supplements to assist their health, and this matter is easily corrected with the following amendment, which will not in any way stop the FDA from identifying truly contaminated food that poses a risk to human health.

"Changes in Existing Law. The following provides a print of the existing statute or part or section thereof to be amended or replaced so as to delete the words “or unreasonable” (existing law proposed to be omitted is enclosed in black brackets, existing law in which no change is proposed is shown in roman):

"CHAPTER IV – FOOD - SEC. 402 (f) – (1) If it is a dietary supplement or contains a dietary ingredient that – (A) presents a significant [or unreasonable] risk of illness or injury under — (i) conditions of use recommended or suggested in labeling, or (ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use:

"Changes in Proposed Bills Proposed amendment to S.1082 and HR.1561:

"The bills are hereby amended to prohibit the Foundation or Institute from evaluating the health benefit or efficacy of foods, dietary ingredients, and dietary supplements and to limit review of foods, dietary ingredients and dietary supplements to a determination of whether they are safe. In assessing whether dietary ingredients and dietary supplements are safe, the Foundation or Institute shall not compare product risks with health benefits or efficacy. Instead, the Foundation or Institute shall determine whether the product presents a significant risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are recommended or suggested in labeling, under ordinary conditions of use..."

My comment: it may seem small, but the words "not unreasonable" do have a big impact... and it is in the small space made by such words (or their deletion!) that Health Freedom has room to grow. This amendment, together with the wording of Dr. Paul's HR.2117, would go a long way toward protecting our access to truthful information about the health benefits of foods. Please note that S.1082 does not explicitly mention Dietary Supplements (except for the DSHEA Exemption Amendment adopted 94 to 0) so the suggested Emord Amendment would change existing law to be more protective of Dietary Supplements by attaching the change to the pending pro-FDA bill, the same parliamentary procedure that has been suggested with Dr. Paul’s bill.

One concern I do have with this amendment is that the recent Supreme Court Ephedra decision, not to review the appeals court upholding the Ephedra ban, effectively means that nearly any risk of illness may be considered "significant" and therefore, the amendment may not be strong enough. However, it may be possible to get it adopted… one step at a time!

This is an especially exciting time to be in the Dietary Supplement / Natural Products market. While stricter regulations seem on the way, scientific advances and ongoing clinical studies point the way to better and more effective products. The problem is not in the science or the production; the problem is in the politics. These products are generally recognized as safe when used as directed, like any food. We therefore need to reject the big government notion that tells us we will only be safe if bureaucrats have more control over us. That nostrum is provably wrong, as we see from the failure of government, with plenary power over approving drugs (as to efficacy and safety) to protect the public from what some estimate to be hundreds of thousands of unnecessary deaths each year from lawfully utilized prescription drugs.

The next few weeks, as the FDA “revitalization” bill is amended or not, and adopted, or not, will tell us a lot about the future of this market. Other important regulatory events are happening this summer as well: the FDA anti-CAM guidance may be finalized; the new Dietary Supplement “Good Manufacturing Practices” have been finalized and should be issued. And, as always, the FDA’s announced intent to “HARMonize” our freedoms to international rules (even where that decreases our access to safe products), operating through the North American Union, Codex and the new US/EU cooperation agreement, remains an ever present threat.

This will be a summer of rapid events; stay up to date, even between VLUeM Memos, by checking my Vitamin Lawyer Health Freedom Blog at: - updated every couple days; also . . .


Advertisement – Now more than ever - “your papers must be in order…” Check my SOP/GMP Information Web Page at: to learn what you need in order to stay on top of changing regulations.


2. Defining Your Target Market

This Entireweb newsletter could be so useful to especially new companies that I am forwarding the entire piece…

> Entireweb Newsletter * ISSUE #340 -

> Define Your Target Market in 5 Easy Steps

> This report is designed for entrepreneurs, small business owners, independent contractors and anyone who needs to build relationships and develop leads or referrals in order to promote and increase their business.

> The information in this report is given based on the assumption that YOU know your product and service inside and out and you have already defined your business goals and have somewhat of a business plan in order.

> The next step would be to narrowly and clearly define your target market, your ideal prospect.

> Some people believe that their products or services would be perfect for everyone. For example, Mary Kay Cosmetics - no offense to my MK friends or other people in the health industry who say 'anyone with skin' needs a facial or 'anyone who has stress' need a massage. Then there are people in the home improvement industry who say, 'anyone with a house' needs my landscaping, my windows, my furniture or my loan, etc.

> For most small businesses however (1-5 employees or even more), I don't believe this is the most effective way to try to generate new leads and customers. If you determine the right target market to fit your business, you figure out the best ways to reach them AND if you figure out the best message to reach them with you will be spending your marketing dollars wisely. Business owners who don't plan ahead to figure out who their target market is before they open their doors end up spending a whole lot more money trying to figure it out by trial and error and that's expensive.

> Would you shell out $200 for a pair of shoes without trying them on? Plunge into a steaming bath without dipping a toe in first? Of course not-but people do the business equivalent every day. Many an entrepreneur has found out too late that nobody wants to buy hand-quilted Christmas stockings at $24.99 a pop, or that wealthy customers won't schlep to the unfashionable part of town for luxury stationery.

> The irony: Conventional market research is expensive (corporations regularly budget tens or hundreds of thousands of dollars for it), but no one needs it more than a startup entrepreneur. A couple of marketing blunders won't put a giant manufacturer out of business, but just one can sink an entrepreneur like a bolt of lightning.

> Defining Your Target Market

> Your "target customers" are those who are most likely to buy from you. Resist the temptation to be too general in the hopes of getting a larger slice of the market.

Try to describe them with as much detail as you can, based on your knowledge of your product or service and how it will benefit them.

> Step 1: Ask yourself some questions to get started

> 1. Are your target customers male or female?

> Figure 75-80% of your target customers would be which? If it's split, narrow it down another way but more than likely you can narrow down the gender.

> 2. How old are they?

> Give an age range of 10-20 years max, otherwise you might have two target markets. Remember, the marketing messages towards different age groups will be quite different most likely depending on your product or service.

> 3. Where do they live?

> Is geography a limiting factor for any reason? Can you narrow it down to specific zip codes or counties? The larger the geographical area you choose, the more people you will find but the less likely you'll be able to afford to market to all of them so narrow it down and expand out later.

> 4. What do they do for a living?

> You can get a mailing list by industry or profession and specific title for example.

> 5. What does their specific profession say about their lifestyle?

> Is it very busy with little time to shop? Would they be likely to be familiar with the internet for their shopping, researching, news and event information? Would they be commuting more in their car?

> 6. How much money do they make?

> This is most significant if you're selling relatively expensive or luxury items. Most people can afford a latte. You can't say the same of custom murals. Narrow this down to a specific range also and high enough that you will weed some people out or again, you'll have way too many people to afford to market to.

> 7. Are there kids in the household?

> What ages might they be? How many would there likely be? What does this say about their lifestyle - are they carpooling, or soccer parents where they are rarely home? Do they possibly eat out a lot or have less 'family' bonding time? Or are they empty nesters where they might spend more time at home watching television or reading?

> Step 2: Get specific

> What other aspects of their lives matter? Here are some examples to think about, see how your target market compares or how you can get more specific with them.

> * If you're launching a roof-tiling service, your target customers probably own their homes. In addition, they probably own homes with older roofs like shake roofs; you can get a list of homes by their age.

> * If you're a realtor, you might be interested in targeting first time homebuyers in which case you might find them to be likely to live in apartments or rentals of which you can get a list of those too.

> * If you're selling your own individual artwork but you can't create multiple paintings with the same picture, you may have to sell the unique pieces at local art shows rather than selling them online.

> * If you're planning to open a custom-tailoring shop and need busy executives to come for three fittings, you may need to limit it to your local area.

> * If you're a direct jewelry consultant needing women to gather for parties in someone's home, you'll want to go where many women meet like mom's groups, women's professional organizations, day cares or grocery stores.

> * If you're a business or life coach and want to coach only over the phone then you'll most likely want to do more online marketing and make sure to have a really top notch website since that's mostly what people are going to see for their first impression. You can network locally too but the more 'known' you are in person, the more people will want to do business with you in person.

> Step 3: Keep your mind open to any information

> Keep a list of primary research questions handy, such as:

> * Who influences your customers and how? Spouses, neighbors, peer groups, professional colleagues, children and the media can all affect buying decisions. Look for hints that one or more of these are a factor for you.

> * Why do they buy? Distinguish between the features and the benefits your product or service offers. Features describe what it is; benefits are what your customers get out of it. The latter is why your customers pay you. Are they looking for a status symbol, a savings in time or energy, a personal treat or something else?

> * Why should customers choose you and not your competition? What can you offer that the competition doesn't?

> * How do your customers prefer to buy? Many businesses benefit from the broader market provided by the Internet and mail order, while others do better with a physical presence. Don't assume you fall into one category or the other; customers may surprise you.

> Step 4: Identify Your Ideal or Favorite Client

> Think about your favorite client - who are they, name them, write down everything you know about them, their family status, age, sex, marital status, where they live, where they work, possible income level, their shopping characteristics.

> * Do they like to use coupons or shop on certain days?

> * Do they call you at the last minute to get something from you?

> * Do they value your service/product?

> * Is that type of client the most profitable type you have or the most non-profitable and you just like them?

> Step 5: Determine their profitability to your business

> Which type of clients will make you the most money, bring you joy and refer you tons of business? These are the types of clients you ultimately want, now where are they?

> Ask Yourself:

> * Who is the most profitable type of client? The one who will make you the most amount of money the fastest and with the least effort - do you like working with them? If not, you won't be totally happy with only this type of person, maybe you need a combination of the two.

> * How often will they be able to buy or consume your product or service? If they can only possibly purchase your services every 10-20 years (getting a new roof for example), do you never market to them again after the sale or do you heavily market to them after the sale by every means possible for at least 1 year to get all the referrals you could possibly get out of them in that time?

> * How likely are they to know others like them they can refer to you? Normally, very likely, in which case following up with them before, during and after the sale is huge - and if you don't ask for referrals in each stage of the sale continuously then shame on you.

> * What is really important to them when it comes to your product or service? Not what you think they should know or like, but actually what they care about, like, ask for, thrive on, are passionate about, etc. These are your target market's "Hot Buttons" and these are what you should be addressing in your headlines, letters and marketing efforts at all times because these are why the client would choose to buy.

> Defining your business' target market is absolutely critical to any small business. Everything you do in your marketing, advertising, design, publicity and networking will depend on who your target market is and what matters to them. Making decisions on your marketing and advertising without fully defining your target market or knowing them in depth could be detrimental to your business and you could be making some costly mistakes!

> About the Author: Katrina Sawa, Relationship Marketing Expert, helps entrepreneurs and independent consultants build their database of clients and prospects, determine the best ways to market their business to their target market, teach them how to network, develop follow up systems, marketing and advertising plans and find ways to get free or low cost publicity which all lead to more customers and increased sales! Visit her at