Joanna Cosgrove06.27.11
In the late 1990s and early 2000s the dietary supplement industry was pockmarked by news about vitamins and herbal preparations that were either contaminated or didn’t contain the ingredients and/or active levels they claimed on the label. Frustrated by the lack of quality assurance and moved by the fact that no group had yet stepped forward to comprehensively police the quality of dietary supplements, Tod Cooperman, MD, decided to do something about it. In 1999 he created ConsumerLab.com to provide independent test results and information to help consumers and healthcare professionals identify the best quality health and nutrition products.
“I learned that FDA was not routinely testing products and was essentially [operating] in firefighting mode, jumping in only when serious injuries or deaths were reported,” Dr. Cooperman recalled. “Others had seen the need for more testing and reporting but no one had gone forward, typically due to fears over liability or political concerns within and outside their organizations.”
When the idea for ConsumerLab.com came to him, he said his first order of business was to recruit a top scientist. “I was fortunate that Dr. William Obermeyer was willing to leave FDA after nine years in the Center for Food Science and Applied Nutrition (CFSAN) to become our vice president for research,” he said. “Dr. Obermeyer is one of the few pharmacognocists in the U.S., an expert in natural products testing.”
On a mission to help consumers identify better quality products through independent testing, Dr. Cooperman and his ConsumerLab colleagues established a protocol to confirm and document the quality issues of herbal products, vitamins, minerals, sports and energy products, and functional foods and beverages. The identity, strength, purity and disintegration properties of products are tested to make sure they meet recognized standards of identity, and does the product meet the level of quality claimed on the label; contain the amount of ingredient claimed on the label; are free specified contaminants; and break apart properly for appropriate use by the body.
According to information provided by the company, each product review is achieved using “appropriate” test methods vis-à-vis analytical equipment such as capillary electrophoresis; gas chromatography with detection by flame ionization detector, electron capture detector and mass spectroscopy or tandem mass spectroscopy; high performance liquid chromatography (HPLC) in conjunction with a variety of detection methods including infra-red, photodiode array, evaporative light scatter detector, mass spectroscopy and tandem mass spectroscopy; high performance thin-layer chromatography (HPTLC); inductively coupled plasma/mass spectroscopy; microscopy and mass spectroscopy.
All of the aforementioned criteria must be met to be considered for approval by ConsumerLab. If the product’s manufacturer seeks the ConsumerLab Seal of Approval on their label, the product must be tested every 12 months based on a random sample purchased on the open market.
“When we find a problem with a product that we have selected for our Product Reviews, we first confirm the problem in a second laboratory (and sometimes even a third and fourth lab), and then publish those findings,” said Dr. Cooperman.
The transparency of the company's approach, he said, has led to “subsequent improvements in many products and even in whole” product categories. “For example, in March 2000 we reported that most chondroitin supplements didn’t contain what they claimed,” he said. “Last year, a minority of products lacked their chondroitin. Still not good, but much better.”
In recent years, ConsumerLab has been strict about lead contamination, applying the stringent California Prop 65 limits. “While we still find lead in some supplements, it’s less common than in past years,” commented Dr. Cooperman.
Despite all of the progress the organization has made in the last 12 years, it still continues to identify new problems, often in categories that have quickly risen to popularity. “For example,” said Dr. Cooperman, “a large percentage of probiotics still don’t contain the amounts of viable organisms listed on their labels [and] we are increasingly seeing signs of adulteration of herbal ingredients, possibly due to increasing reliance on lower cost, lower quality ingredients and non-specific testing methods.”
He said that while the recent dietary supplement Good Manufacturing Practices requirement is a good start toward improving dietary supplements overall, there is still “no guarantee because the law does not include specific standards of what should or should not be in a supplement—only that it be made consistently and with good record-keeping.”
The greatest impact of this law is coming from FDA’s new ability to go in and audit compliance with the rules, he said. “I recently heard that 40% of supplement facilities failed FDA inspections. This is making manufacturers more aware of their problems. But since the government still does not test the products and is not establishing quality standards, it is as important as ever that ConsumerLab.com fill this gap.”
Since its founding in 1999, ConsumerLab has tested nearly 3000 products, representing more than 350 different brands and 60 different report categories of nearly every type of popular supplement for adults, children and pets. In addition, ConsumerLab also conducts an annual "Survey of Vitamin & Supplement Users."
Dr. Cooperman said ConsumerLab does its best to keep abreast of all of the latest supplement trends and will soon be testing digestive enzymes, beginning with lactase supplements. The company is also interested in popular health foods, so it is currently testing coconut waters.
“In addition to our quality ratings, we continue to expand the information that consumers and their healthcare providers get from our reports, such as what a supplement can or can’t do, appropriate dosage, and potential drug interactions,” he said, noting that the company also posts the latest product recalls and warnings.
“We actively read, analyze and report on the latest clinical research," he added. "We are increasingly using social media tools to interact with consumers. Last year, for example, we added a Facebook page, which already has thousands of fans. We seem to be providing what people want, as evidenced by our expanding membership (currently over 45,000 individuals and institutions) and readership of our free newsletter, which now goes out to more than one hundred thousand people.”
Editor's Note: Stay tuned for a follow-up story on best practices in testing, which will appear as an online exclusive later this month.
“I learned that FDA was not routinely testing products and was essentially [operating] in firefighting mode, jumping in only when serious injuries or deaths were reported,” Dr. Cooperman recalled. “Others had seen the need for more testing and reporting but no one had gone forward, typically due to fears over liability or political concerns within and outside their organizations.”
When the idea for ConsumerLab.com came to him, he said his first order of business was to recruit a top scientist. “I was fortunate that Dr. William Obermeyer was willing to leave FDA after nine years in the Center for Food Science and Applied Nutrition (CFSAN) to become our vice president for research,” he said. “Dr. Obermeyer is one of the few pharmacognocists in the U.S., an expert in natural products testing.”
On a mission to help consumers identify better quality products through independent testing, Dr. Cooperman and his ConsumerLab colleagues established a protocol to confirm and document the quality issues of herbal products, vitamins, minerals, sports and energy products, and functional foods and beverages. The identity, strength, purity and disintegration properties of products are tested to make sure they meet recognized standards of identity, and does the product meet the level of quality claimed on the label; contain the amount of ingredient claimed on the label; are free specified contaminants; and break apart properly for appropriate use by the body.
According to information provided by the company, each product review is achieved using “appropriate” test methods vis-à-vis analytical equipment such as capillary electrophoresis; gas chromatography with detection by flame ionization detector, electron capture detector and mass spectroscopy or tandem mass spectroscopy; high performance liquid chromatography (HPLC) in conjunction with a variety of detection methods including infra-red, photodiode array, evaporative light scatter detector, mass spectroscopy and tandem mass spectroscopy; high performance thin-layer chromatography (HPTLC); inductively coupled plasma/mass spectroscopy; microscopy and mass spectroscopy.
All of the aforementioned criteria must be met to be considered for approval by ConsumerLab. If the product’s manufacturer seeks the ConsumerLab Seal of Approval on their label, the product must be tested every 12 months based on a random sample purchased on the open market.
“When we find a problem with a product that we have selected for our Product Reviews, we first confirm the problem in a second laboratory (and sometimes even a third and fourth lab), and then publish those findings,” said Dr. Cooperman.
The transparency of the company's approach, he said, has led to “subsequent improvements in many products and even in whole” product categories. “For example, in March 2000 we reported that most chondroitin supplements didn’t contain what they claimed,” he said. “Last year, a minority of products lacked their chondroitin. Still not good, but much better.”
In recent years, ConsumerLab has been strict about lead contamination, applying the stringent California Prop 65 limits. “While we still find lead in some supplements, it’s less common than in past years,” commented Dr. Cooperman.
Despite all of the progress the organization has made in the last 12 years, it still continues to identify new problems, often in categories that have quickly risen to popularity. “For example,” said Dr. Cooperman, “a large percentage of probiotics still don’t contain the amounts of viable organisms listed on their labels [and] we are increasingly seeing signs of adulteration of herbal ingredients, possibly due to increasing reliance on lower cost, lower quality ingredients and non-specific testing methods.”
He said that while the recent dietary supplement Good Manufacturing Practices requirement is a good start toward improving dietary supplements overall, there is still “no guarantee because the law does not include specific standards of what should or should not be in a supplement—only that it be made consistently and with good record-keeping.”
The greatest impact of this law is coming from FDA’s new ability to go in and audit compliance with the rules, he said. “I recently heard that 40% of supplement facilities failed FDA inspections. This is making manufacturers more aware of their problems. But since the government still does not test the products and is not establishing quality standards, it is as important as ever that ConsumerLab.com fill this gap.”
Since its founding in 1999, ConsumerLab has tested nearly 3000 products, representing more than 350 different brands and 60 different report categories of nearly every type of popular supplement for adults, children and pets. In addition, ConsumerLab also conducts an annual "Survey of Vitamin & Supplement Users."
Dr. Cooperman said ConsumerLab does its best to keep abreast of all of the latest supplement trends and will soon be testing digestive enzymes, beginning with lactase supplements. The company is also interested in popular health foods, so it is currently testing coconut waters.
“In addition to our quality ratings, we continue to expand the information that consumers and their healthcare providers get from our reports, such as what a supplement can or can’t do, appropriate dosage, and potential drug interactions,” he said, noting that the company also posts the latest product recalls and warnings.
“We actively read, analyze and report on the latest clinical research," he added. "We are increasingly using social media tools to interact with consumers. Last year, for example, we added a Facebook page, which already has thousands of fans. We seem to be providing what people want, as evidenced by our expanding membership (currently over 45,000 individuals and institutions) and readership of our free newsletter, which now goes out to more than one hundred thousand people.”
Editor's Note: Stay tuned for a follow-up story on best practices in testing, which will appear as an online exclusive later this month.
