Although we create our own unique herbal formulas, we don’t manufacture and bottle the products ourselves. Instead, we contract out the actual manufacturing to a few carefully chosen, very specialized contract manufacturing companies here in the western United States. We currently use 4 or 5 contract manufacturers in California, Utah and Arizona as suppliers for different products and packages. Why so many?

Manufacturing herbal and homeopathic products is a highly specialized, highly regulated, and machinery-intensive process. Procuring and testing raw ingredients, weighing them, blending them together, putting the blended powder into capsules, and packaging them, all requires a great deal of specialized machinery, but more than that, those machines require temperature and humidity control, positive air pressure and filtration to control dust particles, and special manufacturing buildings to house the air-handling equipment and the machinery. Both the buildings and the machines must be easily and completely cleaned between each product’s production run. Particular formulas may require additional equipment, like high-shear particle granulators, flash dryers, liquid heaters and stirrers, or capsule/tablet spray coating equipment.

Keeping all these machines running requires a lot of scheduled maintenance. It also requires unscheduled maintenance, because machines break. Fixing them quickly requires an on-site machine shop capable of fabricating repair parts to precise tolerances in food-grade and pharmaceutical-grade stainless steel. And because the equipment is so expensive to buy and maintain, you really need to be running at least two eight-hour production shifts a day to make the investment pay off. Since each encapsulation machine can typically produce between 100,000 and 300,000 capsules per hour, this translates to between 1 and 5 million capsules per day.

Liquids and creams (Like ClearLungs Liquid and Chest Rub) usually need to be manufactured in an environment that is completely separate from dry powder facilities (like capsules and tablets) to prevent dust contamination of liquids or spills that contaminate powders. Contract manufacturers typically do liquids or powders, but not both. Those few companies that manufacture both liquids and powders typically house them in completely separate buildings.

And then there are the regulations. Sometimes you may hear from uninformed journalists that supplements are unregulated, but don’t you believe it. Every aspect of supplement manufacturing is regulated through Good Manufacturing Procedures, or GMPs. Some industry comedians claim that GMP stands for “Get More Paper”, and they aren’t far off. Master manufacturing records, individual batch records, written procedures for everything from how to wash your hands or scrub a toilet, to how long to blend powders to make sure they are uniform. Detailed testing is required for each individual input ingredient, and then more testing is required again for the final manufactured product.

As if that wasn’t enough, homeopathics are classified by the FDA as over-the-counter (OTC) drugs or pharmaceuticals, which require even stricter regulations, and a completely different set of GMPs. For example, while supplement labels (like food labels) must list ingredients in descending order by weight, drug ingredients must be separated into “active ingredients” like homeopathics, and “inactive ingredients” (anything else), and each category must be listed alphabetically on the label. Less than one in 10 contract manufacturers of supplements is also qualified to manufacture OTC drugs, and most wouldn’t even want to.

For all of these many reasons, the actual manufacturing of any natural product is best left to the experts at contract manufacturing firms, at least until a company reaches a size sufficient to warrant its own custom production facility. Most natural products companies don’t reach that point until they become very large (often publicly-traded) companies. Finding the very best contract manufacturers isn’t easy, but our need for OTC manufacturing weeds out a lot of lesser candidates, and our careful review and on-site qualification process ensures that we always have trusted, capable and reliable manufacturing partners.

But our work doesn’t end there. We also inspect every finished batch of product ourselves, to verify that ongoing production regularly meets or exceeds our requirements and standards. And we work closely with each manufacturer to ensure that our products are continuously improved over time as processes and standards evolve. Making great products is never easy, but good partners make it possible.

I am often asked where our herbs come from. As an eclectic herbal company, our herbs come from all over the world. Our herbal ingredients come from every continent of the world, except Antarctica– which doesn’t grow many herbs.

Obviously, sourcing quality herbs from so many different geographic locations is a challenge. And we often read sensational headlines about supplements that are laced with prescription drugs, or that contain dangerous chemicals. However, the companies that sell these products are usually fly-by-night firms, that buy complete predefined formulas from disreputable overseas suppliers, and sell them on the Internet. These products are almost always intentionally spiked during production, in order to make the formulas more effective.

Our products, on the other hand, are manufactured entirely in the USA. The ingredients are sourced as individual herbs, and are purchased only from well-known and trusted suppliers. Since the suppliers don’t know what the herbs will be used for, there is little incentive to spike them. And since each separate herb has well-known physical and chemical characteristics, it would be difficult to spike them without the adulteration being noticed.

Still, ensuring overall quality of herbal ingredients is a very real challenge, and we meet that challenge with a combination of teamwork and process. Teamwork means that we rely on known and trusted supply partners who make it their business (and reputation) to provide quality ingredients. In addition, we make it our process to further test our products, to ensure that our product specifications are consistently met or exceeded.

There are three important qualities that need to be adequately assured for each individual herbal ingredient: identity, potency, and purity. These major areas of concern can be further broken down as follows.

• Identity: Is this the correct species of herb? Has someone sent common licorice (Glycyrrhiza glabra) instead of Chinese licorice (Glycyrrhiza uralensis)? Is it the right part of the plant? Has someone sent dandelion leaf instead of dandelion root? Has the herb been grown, harvested, and processed correctly? Is it whole herb, cut and sifted pieces, or powder? Are the granules the right size for encapsulation? Is it the correct kind of extract?
• Potency: Is this the correct strength of herb? Is it fresh enough for use? Is it correctly harvested, cleaned, dried, and powdered? If an extract, is it the right process and potency? Does it have the right chemical markers?
• Purity: Has the herb been adulterated with drugs or other chemicals? Has the herb been sulfured to make it look fresher than it is? Are there residues from pesticides or other agricultural chemicals? Does it contain elevated levels of heavy metals like lead and arsenic? Have root crops been washed clean from surrounding soil before drying and powdering? Is the herb contaminated with dangerous germs like E. coli or Salmonella? Is the overall bacterial count too high? Or is it too low because it has been improperly radiated or gassed, as opposed to properly treated with steam or UV light to reduce benign bacteria count?

Obviously, not every possible test can or should be performed on every single batch of herbs. As an extreme example, we could run a DNA identity test on every batch, or even every individual drum of powdered herb, but the cost would be astronomical, and would ultimately have to be passed on to the consumer. On the other hand, at least one identity test needs to be run on every ingredient, and microbial tests need to be performed on every batch of finished product.

Some problems are more likely than others, and some problems are more dangerous than others. Likely or dangerous issues should of course be tested for more frequently, and more stringently. Other tests can be omitted, or tested for only periodically, if the problems they detect are unlikely, or not immediately dangerous. If these problems do crop up in random or sporadic quality testing, they can be made part of the routine testing program until they get resolved.

In reality, some tests are just as effective, and far less costly, than others. For example, organoleptic testing (testing by appearance, smell and taste) may be low-tech, but human senses have not yet been surpassed by scientific instruments for speed, effectiveness and value for identity and potency testing in many (but not all) circumstances.

But by far the best way to increase quality and lower costs is to know your supplier. Good companies use well-known and respected suppliers, because they know that their products and their reputations depend on good quality ingredients. Reputable suppliers in turn know their sources of supply, and they do a lot of testing when they buy the herbs, so as to reduce the amount of testing that needs to be done later by their clients.

In the end, quality is largely a matter of trust. Trusted suppliers provide trusted ingredients, which can be used by reputable manufacturers to create trusted and effective products. No amount of testing or government regulation can eliminate all crooked manufacturers from the marketplace, but luckily, you don’t have to buy from them. Do your homework, ask your local retailer, and buy effective products from reputable companies, and you can save yourself a lot of trouble.

The headlines today were full of news about the two bombs that exploded near the finish line of the Boston Marathon.  My heart goes out to the victims and their families, and I wish that all those who were injured may have as speedy and as complete a recovery as may be possible.  I hope that eventually, they can move past this great tragedy and go on in time to live full, happy, and blessed lives.

At the same time, I am saddened and sickened that any human being could commit such a callous and atrocious act.  I have no idea what their motivation may be, and no one has claimed responsibility as of yet.  But whatever their perceived “cause” may be, they have done it irreparable harm.  No “cause”, however correct, can possibly ever justify the random slaughter of innocent people.  Acts of terrorism such as this serve only to prove the inhumanity and completely overwhelming moral inferiority of those who commit them.

Those who stoop to violence have already lost the argument.  If this is the best or only way to make their case, they have no case to make.  No one will applaud them, no one will understand or pity them, and no one will ever be convinced to their so-called “cause” by their senseless violence.  Nor should we allow ourselves to be intimidated by them, whoever they may be.  They should swiftly be brought to justice, and then both they and their supposed “cause” should be just as swiftly forgotten.

I am also saddened that the media are turning this tragedy into such a spectacle, as they always do.  As sad as this event is, I really feel that we all need to turn off the TV and let the police do their job.  Watching this tragedy unfold does not make us better, more caring, or more feeling human beings.  It just makes us voyeuristic, which is not an attractive human attribute.

And the media coverage certainly does not help clarify our thinking about these and other tragedies.  We need to see behind the sound bites, and try to better understand, and eliminate, the root causes of violence, rather than focusing on the tools used by terrorists and the bloody results.  One of the contributing causes of terrorism is undoubtedly the massive media publicity that such events receive.   Why give a terrorist an audience?

Our home city, Salt Lake CIty, is the host to the next major U.S. marathon, which happens next week.  I hope and pray that this next sporting event can be held without incident, and that it can be a next step on the long road to healing.  May we all do what we can to make this a better, more wholesome, and less violent world.

Last weekend (March 7-10) we went down to the Natural Products Expo West trade show. As always, it was a great opportunity to renew old friendships and make new ones. And once again, I was struck by the unique nature of the people at that show, and in this industry. Expo West is a great place for people-watching, because there are so many different people from all over the world, with so many different cultures and ideas. I enjoy it so much!

Newcomers to the industry sometimes ask, as a young man did last weekend, “what is the most important herb to know about and use?” The answer, of course, is “whichever one you need.” Every body is different, and has differing strengths, weaknesses, and challenges. Which herb is most important to you depends both on your needs right now, and what herbs are available to you locally. Every body reacts a little differently to different things, and though some broad observations can be made, the devil is always in the details. What is best for one person is not always best for another.

I often hear people say that natural products are much safer than drugs, and in fact, experience shows that they are. But why are they safer? Hemlock is natural, and so are arsenic, lead and mercury. All of these materials occur naturally, and they are not safe to ingest. Even small doses can be poisonous. So you really can’t say that all natural things are safe.

But natural products, as an industry and as a whole, are very safe, and remarkably effective too. Why? I think it is because we humans have experienced our natural world, with all its many natural foods and herbs, for many thousands of years, and have recorded that knowledge and experience for almost as long. During that time, a lot of knowledge has been accumulated about which herbs and materials are helpful, which are harmful, and how they can be safely used to improve health and enhance living. Each of us continues that tradition as we share our own experience with our children, relatives, friends and acquaintances. The world becomes better for us, as we experience more and learn more about how it works. There is no substitute for experience, and clinical trials are only one (very short-term) form of experience. A bigger part of experience is provided by the great diversity of people and cultures, trying things in much less precisely controlled environments, also known as “real life”.

So to all of you who share in that tradition, and help to improve health by increasing knowledge about natural healing and natural health, I thank you. You brighten my day, and give me hope for a great future!

Last Wednesday, November 14, 2012, Ron Paul gave his farewell address on the floor of the United States House of Representatives.  His 48-minute address was a remarkable one.  In it, he gave a simple but compelling argument that the United States is slipping slowly (or quickly) toward totalitarianism.  He is absolutely correct.  You can read or view his complete address at one of the links below.

Too many of us fail to understand the limited role that government, and especially the federal government, was supposed to have under our Constitution.  The founding fathers feared, with good reason, that too much authority in the federal government would be fatal to our personal liberties. Today it seems axiomatic that the federal government can regulate anything for any reason, use tax money to bail out any failing industry, and spend us out of any recession.  It can’t. These kinds of actions cannot continue, neither under our Constitution, nor under the natural laws that govern economies and societies of any kind.

Many “progressives” believe that “something should be done” to help the poor, advance the arts, and do many other good works. They are correct. The problem is that such good works cease to be “good” the instant that government becomes involved. We must ALL understand clearly, as Ron Paul does, that EVERYTHING that government does is done by force, and ultimately at gunpoint. Tax money spent on the arts, or Big Bird, or parks, or anything else, is ultimately collected from the people by force. We should use that power sparingly– most of these projects could be funded just as effectively, and much more appropriately, with voluntary donations, which are both more accountable and more ethical in their nature.

I recently read Dr. Paul’s book “Liberty Defined: 50 Essential Issues That Affect Our Freedom”, which is a collection of 50 short essays on topics from abortion to war. There are very few subjects on which I disagree with Dr. Paul. I encourage all Americans to read this very thought-provoking book. I hope that many others will pick up the cause so nobly advanced by Dr. Paul, and I hope his words will have a long-lasting influence on the Congress of the United States.

Watch the speech here, or read the full text.

Recently I had someone ask about whether cellulose, and specifically the  microcrystalline cellulose (MCC) that we use in some of our capsules, contains GMO.  People often wonder about some of the lesser-known, inactive ingredients they see on product labels–and we welcome that.  But first let’s explain first why we use it at all.

Encapsulating herbs is not always easy.  Many herbs contain sticky resins that tend to make the herbal powder particles clump together, and they can stick to machine parts and prevent them from operating.  If you can’t put these sticky herbs into capsules, you can’t get them to people who need them.  To get these sticky herbal powders to flow freely, you need to add other herbs that are not as sticky.  Or, in some cases, you need to add an excipient (sometimes called a flow agent)– an inert or inactive ingredient whose only job is to keep the herbal powder from sticking too much.

There are many excipients that are commonly used in the nutrition industry, including cellulose powder, microcrystalline cellulose, silica, magnesium stearate, stearic acid, and many others.  Some are more effective as flow agents than others.  Some are less healthy than others, too.

We deal mainly in herbs, and most herbs, like most other plants, are about 60-90% cellulose (also known as dietary fiber) by dry weight. So to me, cellullose seems like a good choice.  But ordinary cellulose powder is not a very good flow agent, and it takes a lot of it to make up for a really sticky herb.  But cellulose powder is also cheap, and some companies use it as a filler.  We never do.

Microcrystalline cellulose, or MCC, is a specially prepared form of cellulose that is an excellent flow agent.  It is more expensive than cellulose powder, but works much better, so we can use smaller amounts.  It can also be used as a carrier for homeopathic formulas (we call this “homeoactive” formulation).

Both cellulose powder and microcrystalline cellulose are typically derived from wood pulp.  The same is true of the vegan capsules we use for our products.  Capsules are actually made of hypromellose, more commonly known as hydroxypropyl methylcellulose (HPMC), a form of cellulose gel that dissolves rapidly in stomach acid.

Occasionally you will read a silly article complaining about cellulose powder as “undigestible wood pulp”, and saying that humans lack the enzymes to digest cellulose.  While technically true, this alarmist argument frames the wrong issue altogether.  Whether from wood, cotton, or asparagus, ALL cellulose (in other words, “dietary fiber”) is indigestible, but that doesn’t mean it isn’t an important part of your diet.  Dietary fiber provides bulk, which allows the gut to absorb nutrients and eliminate wastes, performing a critical role in intestinal health.

Some of the best herbs in the world are “wood pulp”, including both cinnamon and licorice root. In fact, being made of wood pulp is currently the best guarantee that these ingredients contain no genetically modified organisms (GMOs). To date, only one tree (papaya) has been genetically modified. All of the wood grown for the lumber industry, which is the best source of cellulose raw material, is still genetically unmodified.

For more information on these ingredients, see the following links:

MCC: http://www.fao.org/docrep/W6355E/w6355e0l.htm

HPMC: http://en.wikipedia.org/wiki/Hypromellose

GMO Trees: http://www.rff.org/News/Features/Pages/Genetically-Engineered-Trees.aspx