All nutritional supplements are made pretty much the same way. Right? Wrong! This is because not all supplement suppliers are alike. Many suppliers of nutritional products (from multi-level marketers [MLMs] all the way up to large corporations), are not even manufacturers-they are simply brokers, distributors or repackers, so you don’t even know who is making your supplements.
And if your supplier is actually making product, there are no strict rules governing the manufacture of nutritional formulas like there are for pharmaceutical products. Unlike pharmaceutical manufacturers in the US and natural medicine manufacturers in Europe and other parts of the world, supplement manufacturers have no formal quality control regulations or inspections, except for the most basic cleanliness parameters (which also apply to your local fast food restaurant).
Making supplements is much more complicated than making food! So if you want the best quality products, you need to work with a company that can assure you of a higher level of quality control than just clean floors and a friendly smile.
For example, how do you know that your patient is getting 100 mcg rather than 100 mg of selenium-a nutrient that is a powerful antioxidant protector at microgram levels but potentially toxic in milligram levels? Are you sure that the echinacea product you are giving your patients is the correct species of the plant? The correct part of the plant? Processed to provide optimum bioavailability? Are you sure those coenzyme Q10 capsules contain the real thing and not just a mixture of riboflavin and folic acid which looks just like coenzyme Q10 (this really happened).
The only way to be sure is to use products made in a fully licensed, federally registered pharmaceutical manufacturing facility. These facilities are required (and are regularly inspected) by the Food & Drug Administration (FDA) to follow very strict quality guidelines and the Good Manufacturing Practices (GMPs), extremely important procedures which ensure quality in manufacturing.
There are many things that set a superior manufacturer apart from those who are not registered for over-the-counter and prescription products and suppliers who are simply distributors, repackers or brokers. The best way to discover these differences is to ask questions.
Don’t be afraid to ask these three key questions of your suppliers!
1. Is every batch of every ingredient tested to confirm that it is what it says it is when it comes in the door at the manufacturing plant?
The coenzyme Q10 story mentioned previously actually happened because unscrupulous suppliers of raw materials (the starting ingredients of any supplement) put out bogus product! It looked like the real thing. It even tested out to be the real thing on limited testing equipment. Only sophisticated chemistry equipment that is not even available to most supplement manufacturers was able to determine that it was not the real thing. Why did they do it? To make money! The real coenzyme Q10 is very expensive, and selling a mixture of B vitamins at coenzyme Q10 prices brings a very high profit!
Ask your supplier if all starting ingredients are held in quarantine until their quality control department physically and chemically tests the quality of each raw material for identity, strength, purity and safety.
Ask if they have a staff of chemists using the most modern analytical methodology, such as atomic absorption, high pressure liquid chromatography, UV/visible spectrophotometry, capillary electrophoresis, and infrared spectrophotometry.
Ask if they have a microbiology lab that can assure the absence of contaminants, such as E. coli and salmonella, and the presence of micronutrients, like vitamin B12 and folic acid.
Only after a material has been identified and assayed and the quality guaranteed, should it then be released from a quarantine area for use in production. If it doesn’t meet standards, it should immediately be returned to the supplier (who will probably sell it elsewhere to less discriminating manufacturers!).
2. Does every batch of tablets go through a disintegration test?
Tablets have to “break down” in the digestive tract before the body can use them. If a supplement is not produced under strict quality control, it may be too “hard” to break down completely in the stomach. This means the patient does not receive the full benefit of that supplement because large amounts may be excreted. To ensure proper utilization, a disintegration time test should be performed on each batch of tablets. This test identifies how and when the product will break down in the body.
The disintegration time test consists of a laboratory apparatus that approximates a “normal” stomach to see how a tablet will behave when it gets in the body. It exposes the supplement to the temperature, biochemical environment and motions that actually occur in the stomach, and the break down of the tablet is monitored over time. Different formulas have different ideal disintegration times. Most products should disintegrate (break down to a powder) in about 30 minutes to one hour. Timed or prolonged release products are specially designed to take longer to disintegrate in order to improve utilization of certain nutrients. They may even stay partially “intact” after releasing their nutrients, a normal situation for these products. If the disintegration time is not right for a particular product, the patient will not receive maximum benefit.
Some have tried a home version of a “disintegration time” test by putting tablets into a glass of water or vinegar and waiting for them to dissolve. This test is totally inaccurate for 99.9% of supplements, with pure calcium carbonate being the only thing for whick the test is appropriate! It’s just not similar enough to a real stomach when determining how a complex nutritional formula will behave in the body. Anything more complex simply won’t break down unless it is under the temperature, biochemical and motion conditions present in the stomach. After all, you can’t dissolve a piece of steak in a glass of vinegar either!
3. Are the best forms of the nutrients being used and is the tablet or capsule being put together properly?
Many companies’ formulas look good on the label, but research and development are much more than putting down a good formula on paper. Take herbs for example. Most herbal products are simply cut and dried plants put into a capsule or tablet. That may be fine for very general use, but for therapeutic use most herbs must go through an “extraction” process to break open the plant cell walls and “release” the active ingredients for optimum bioavailability and digestibility. In fact, this is how herbs are traditionally prepared in China, Europe, and other parts of the world that successfully use herbs medicinally. Many people believe that you can only have an “extract” in a liquid form, which usually has very low patient compliance due to poor taste, excessive amounts of alcohol, and the inconvenience of dropper bottles. But new technology allows the power of a liquid extract to be put into the convenience of a capsule or tablet. Ask your supplier if they are using these advanced delivery systems in their products!
There are also many other issues relating to “delivery systems” that determine whether the patient will receive the optimum benefit from their supplements-all of which occur at the research and development level. These include precoating nutrients to prevent interaction within the tablet, granulating or chilsonating ingredients for even ingredient distribution throughout the tablet or capsule, high tech controlled release beadlet delivery systems to optimize bioavailability of water soluble nutrients, and enteric coating of enzymes to maximize their activity. These and other special processes make formulas developed at a sophisticated facility very, very different indeed from those made in a warehouse with a blender and a tableting machine!
Quality really does cost more
And finally, you really do get what you pay for. Yes, a staff of full time chemists and technicians, hundreds of thousands of dollars in advanced laboratory equipment, and a high-tech research and development lab is going to result in a more expensive product than one made in facilities like your local fast food restaurant!
In fact, that small extra cost up-front can actually mean more economy for your patient in the long run. For example, being able to use less capsules per day of a highly potent herbal extract compared to the cut and dried products. Or when high potency water soluble nutrients are supplied more efficiently throughout the entire day through the use of controlled release beadlet delivery systems, not simply excreted in the urine. And, finally, when you are making recommendations to your patients, it’s worth the extra “insurance” to know that you are providing them with the best quality supplements possible!
Georgiana Hennessy, whose background is in chemistry, currently is the general manager of the Anabolic Laboratories division of Anabolic Laboratories, Inc. She has been with the company for 19 years. Headquartered in Irvine, California, Anabolic has been manufacturing quality nutritional supplements and other chiropractic supplies for over 70 years. You can visit Anabolic’s web site at anaboliclabs.com or call 714-863-0340.
Seven More Questions to Ask Your Supplier
- Once equipment has been used, is it dismantled and thoroughly cleaned before it’s released for use again? (You would be surprised to know that some companies only clean their equipment once a week!)
- As the product is being made, are samples tested every 20 to 30 minutes for compliance with weight, hardness, shape and size requirements? (If a tablet is too hard, it will not disintegrate properly, and if it is too soft, it will not survive shipping across the country.)
- Are batch records kept on every starting material and finished product that goes in and out of the facility? How many years are they tracked? (Many companies have virtually no paper trail to track what goes into their products.)
- How long has the company been in business? (There are many start-up companies out for a quick dollar that have no real experience in what it takes to produce quality supplements.)
- Do they have a pharmaceutical license? (Ask to see a copy of it.)
- Do they encourage tours of their manufacturing facility? (This is the best way to see first-hand how a company operates.)
- Is there a video or other educational materials available to show patients how their products are manufactured? (These materials help patients understand why they should obtain their supplements from you, their health care professional, instead of a clerk at a retail store.)