Nutritional supplements Physician Grade vs. OTC

Nutritional supplements Physician Grade vs. OTC
April 2007
By John V. Wood
Chiropractic Economics

Many Americans take over-the-counter (OTC) vitamin supplements in an attempt to fulfill their daily nutritional needs.

A new study, however, shows some vitamins do not help those nutritional needs, and might even be detrimental to your health.

ConsumerLabs, a leading provider of independent test results and information to help educate consumers and healthcare professionals, performed a random test of 32 popular OTC vitamin supplements. Among those products selected, only 10 met their claims and other quality standards. ConsumerLabs found:

* A women's multivitamin was contaminated with 15.3 micrograms of lead per daily serving;
* A children's vitamin contained 216 percent of its labeled amount of vitamin A;
* Three multivitamins Û one for women, one for men and one for seniors Û did not fully break apart (disintegrate); and
* One multivitamin contained none of its claimed vitamin A.

ConsumerLabs looked at one lot from each of the 32 supplements. When Matt Lauer of NBC's Today Show asked if this was reliable testing ConsumerLabs' president Dr. Tod Cooperman defended the amount of supplements chosen.

"No lot should ever be bad when it comes to vitamins," Cooperman said. "Ideally, you'd like to look at every lot available. We decided to look at one individual lot [of each supplement] instead, and examine it very carefully."

After the release of the study, media outlets began running with the story. One news agency chose the headline, "A vitamin a day might do more harm than good."

Andrew Halpner, vice president of product development and technical services at Douglas Laboratories, a physician-grade supplement manufacturer, challenges this type of sensationalistic reporting.

"This headline is exactly the type of sensational reporting that helps to keep a cloud of suspicion over the dietary supplement industry," Halpner said. "A product that is reported to contain only 80 percent of a claimed amount of a nutrient is reason for further investigation, but to brand the entire category of dietary supplements as potentially harmful is simply poor reporting."

Physician-grade supplements were not part of the study. Are these supplements better? Chiropractic Economics spoke with several other manufacturers of physician-grade to find out. The individuals questioned were Halpner; Jennifer Cherry, president of Nutraceutics; Allan Wilson, national manager at Anabolic Laboratories; Matthew Armstrong, vice president of A.C. Grace Company; Ann Holden, vice president of quality control, and David Barnes, PhD, director of research, both with Standard Process; and Richard Drucker, CEO of Drucker Labs.

WHY ARE PHYSICIAN-GRADE SUPPLEMENTS BETTER?

The term "physician grade" refers to professional market supplements available only to and marketed exclusively to doctors.

"It is in the [supplement] manufacturer's best interest to ensure that their products conform to all labeling requirements, that all ingredients are present as labeled and that products do not contain deleterious materials," says David Barnes of Standard Process. "We expect to be held to a higher standard."

Several of the people questioned identify the fact that professional market supplements are held to high accountability statistics, and are tied directly to the results they provide.

"When companies provide products to a doctor, they know the results will be monitored. If the product does not do what it should, the doctor stops using it," says Allan Wilson of Anabolic Laboratories. "That feedback loop does not exist only in the consumer market, and also acts as a quality gauge. To survive in the 'physician only' market, a supplement company must provide products that yield consistent results."

Jennifer Cherry of Nutraceutics adds the educational access doctors have with physician grade supplements help as well. "Companies specializing in the physician market have better educational tools for the doctor. We have trained and qualified employees to answer any question or concern that may come our way," Cherry says.

"We know about drug interactions and contraindications. We know about the conditions we are nutritionally supporting. We know the science inside and out."

WHAT ABOUT QUALITY CONTROLS?

According to Ann Holden of Standard Process, the law requires the same level of quality control for both physician-grade and consumer OTC markets. "Products which do not contain the ingredients at the levels indicated (within a specified margin of error) are in violation of the law," Holden says. "Some ingredients may be produced to a certain set of standards such as the United States Pharmacopoeia (USP), however such standards are not available for all ingredients."

"[Companies specializing in physician-grade supplements] have worked very hard to gain the trust and confidence of physicians and for our sterling reputations in the industry," Cherry adds. "There is no way we would jeopardize this by putting out an inferior, low-quality, contaminated product. It would just never happen."
Turn bad news into good

The "contaminated vitamins" story may have raised concerns among your patients about the safety and value of taking nutritional supplements. Even if your patients do not bring up the news stories, you can use the bad news as an opportunity to talk to your patients about the benefits of taking the proper supplements Û physician-grade.

"This type of information is a strong reason to have a patient/clinician partnership when using nutrition as a tool in health promotion and for clinicians to do their due diligence," Holden says. "High quality companies who have been in the marketplace for many years are good resources. This type of information should prompt clinicians to ask good questions of the companies selling them products."

"DCs must first make their own value judgment. Their education qualifies them uniquely to educate their patients and the end consumers on proper supplementation," Drucker adds.

"They are qualified from both nutritional and long-term wellness. It is incumbent upon them to recommend the proper choices for their patients. Carrying good quality products in their offices is a service they should provide," says Drucker.

To Wilson, the solution is quite simple. "DCs need to have that [MSNBC] article in the waiting room, bulletin board, or treatment room. Answer questions with any variation of these: 'We offer products that are only available to doctors, and these products are made in a regulated pharmaceutical facility, so articles like this do not apply, as these are manufactured to a different standard.

"'It is guaranteed that what is on the label is in the product. You won't find these items at the grocery store, and we have seen consistent results with these products for decades.'

"The cornerstone of exclusive products is they are only available from the doctor, and they are part of the patient's ongoing healthcare," he adds.

IS THERE A DIFFERENCE IN OTC SUPPLEMENTS?

"It's not really a question of physician-grade vs. OTC; rather it's about substituting fake vs. real nutrition," says Richard Drucker of Drucker Labs. "Many OTC supplements use synthetic chemical nutrients (as opposed to natural and organic sources) because they are much cheaper to manufacture, and putting a vitamin into a mega-drugstore is all about profit margins."

Matthew Armstrong of A.C. Grace Company says it comes down to quality. Armstrong believes raw materials have to be checked and double-checked, and companies have to perform independent assays to verify potency, among other things.

Physician-grade supplements, according to Wilson, are formulated with a specific result in mind. They are not intended for a person to use over the counter, as they often have very high amounts of particular actives to help the doctor manage a case. "These products are designed to be part of a protocol," Wilson says. "Consumer products are designed for maximum sales and profit impact."

WHAT ABOUT STATED LABEL CLAIMS?

Governed by FDA, DSHEA, and FTC, all supplements must meet stated claims and not make unsubstantiated health claims. According to Wilson, standardizing natural products is a real challenge, and the only way to guarantee potency is to test the product. It is very difficult, especially when premium natural materials are used Û which is typical of physician-grade products.

Image of pills spilled into a handWilson has a great illustrative example of this question. "Using a multivitamin image, let's picture a box that is 12 feet long, 6 feet wide, and 6 feet deep. You could probably fit a car in it. Now you have that whole box filled with powder (all the multivitamin ingredients) and you're blending it.

"Time to add selenium Û which you could fit in a soup bowl. You open the box and dump it in, but how can you be sure that tiny bit of selenium is going to blend evenly in that huge box so that when you make tablets, you have the 200 mcg of selenium present Û no less and certainly no more Û in the thousands of tablets you're making? The only way to know is to test for selenium. Test the blend, test the tablets."

A quality company ensures the label meets the claim by assaying the finished product before it is released for sale to the general public, says Cherry. "All ingredients stated on the label must be assayed to ensure that the finished product meets label claim."

HOW IS CONTAMINATION AVOIDED?

Sealed production rooms, documented cleaning procedures, and a whole host of controls must be put in place to insure purity in a pharmaceutical plant, according to Wilson.

"Think about a grill at the restaurant Û the cook puts down a burger, it gets moved, and down goes some chicken, then a steak, then some shrimp. If a little juice from another food mixes in, no problem," Wilson says. "But if you are dealing with controlled substances, then contamination becomes a federal offense."

Cherry says raw materials need to be tested for purity and identity, microbial contamination, and environmental toxins such as lead. "As a doctor, I would insist the brand I recommend has this [testing] information available. I would ask for this documentation on the lot number I was selling. Some companies will do it one time on one batch or lot number and then claim it to be true for a different batch or lot number."

HOW IS DISINTEGRATION TESTED?

According to Wilson, tablet samples must be taken regularly during production and tested for hardness, thickness, weight, and friability, versus a set specification for that product. "If the product is compressed too hard, then it is basically a rock, and it will never pass disintegration testing," Wilson says.

Image Pill Cracked"Physician-grade per se doesn't mean they dissolve faster or better; rather, companies selling in this market have a high likelihood of conducting the appropriate diligence and reject products which don't meet their specifications," Barnes says.

A simple laboratory disintegration test may not tell the whole story, says Cherry. "Factors such as the pH and amount of gastric juices in a person's gut come into play," Cherry says.

HOW TO CHOOSE AMONG PHYSICIAN-GRADE PRODUCTS?

Holden believes the answer lies in the QC documentation of the supple-ment providers. "Clinicians may request that supplement companies document quality control procedures such as how much testing is conducted and by whom and who inspects their manufacturing facility," Holden says.

"Other considerations might include how long they have been in business, whether they have their own manufacturing facility (and therefore have more control) or have product manufactured for them, and whether they produce any of their own raw ingredients."

Wilson says quality-control testing of incoming materials is important in a pharmaceutical company such as his. "If a pharmaceutical company does something wrong, penalties could include prison time for all involved employees Û quite a significant increase over a 'cease and desist' letter and possible fine by the FTC."

Cherry believes that if you are a chiropractor, your reputation is at stake whenever you are dealing with supplements and other means of patient wellness.

"Everyday I see new companies entering the physician market. It is actually quite scary, because many of these companies are not offering quality education and products. How is the doctor supposed to know what's going on?" Cherry says.

"If there is a new company that you are interested in, ask questions such as, 'Do you have PhDs on staff? Do you have pharmacologists on staff? Can I see your assays?' Ask hard questions. If you do not get the answers you are looking for, run! This is your reputation on the line."