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About ConsumerLab.comOVERVIEW:
ConsumerLab.com, LLC ("CL") is the leading provider of independent test results and information to help consumers and healthcare professionals evaluate health, wellness, and nutrition products. It publishes results of its tests in comprehensive reports at www.consumerlab.com which receives over 3 million visits per year from consumers and health professionals. CL also conducts an annual Survey of Vitamin & Supplement Users. CL’s research is cited frequently by the media, in books, and at professional meetings. In addition to the products it selects to review, CL enables companies of all sizes to have their products voluntarily tested for potential inclusion in its list of Approved Quality products and bear the CL Seal. Since its founding in 1999, CL has tested more than 2,100 products, representing over 350 different brands and nearly every type of popular supplement.
INDEPENDENT TESTING OF PRODUCTS: Types of Products Tested: CL evaluates consumer products relating to health, wellness, and nutrition, including:
Health & Nutrition Products:
- Herbal Products
- Vitamins
- Minerals
- Other Supplements
Prescription Medications
Sports & Energy Products
Functional Foods
Foods & Beverages
Personal Care Products
From time to time, CL may evaluate additional types of products that impact consumer health, wellness, or nutrition.
How Products Are Tested: ConsumerLab.com has perhaps the highest testing standards of any third party group certifying the quality of dietary supplements. ConsumerLab.com is also the only third-party verification group that freely publishes its testing methods and quality criteria/standards. These can be found at www.consumerlab.com/methods_index.asp.
Products are tested, whenever possible, for each of the following:
Identity: Does the product meet recognized standards of identity and does the product meet the level of quality claimed on the label?
Strength (quantity): Does the product contain the amount of ingredient claimed on the label?
Purity: Is the product free of specified contaminants?
Disintegration: Does the product break apart properly so that it may be used by the body? [See ConsumerLab.com Home Test for Disintegration for how to test your supplements]
These quality criteria must be met to be considered Approved by CL. If a manufacturer seeks to use the CL Seal of Approval on the product, the product must be tested for these criteria every twelve months based on a random sample purchased on the open market.
Quality Criteria / Standards:
The FDA’s Good Manufacturing Practices (GMPs) for dietary supplements leave quality standards and analytical methods up to each manufacturer to determine for itself. Some choose to use less specific standards and/or lenient test methods that can make a low quality product appear to be high quality. We see no reason why consumers should accept low quality ingredients or unnecessarily expose themselves to avoidable contaminants. We adopt the most meaningful and strict standards based on the latest international research and recommendations.
For example, the amount of lead contamination that some U.S. companies and other third-party testing groups permit in supplements can be as much as forty times higher than what ConsumerLab.com would permit and what is allowed in the State of California without a warning label. Our standards can be found at www.consumerlab.com/methods_index.asp
Analytical Methods:
CL seeks to use the most accurate and appropriate test methods for each ingredient. Each
Product Review provides a link to the methods used. Below are examples of analytical equipment employed:
CE (capillary electrophoresis)
Gas chromatography with detection by FID (flame ionization detector), ECD (electron capture detector) and MS (mass spectroscopy) or MS/MS (tandem mass spectroscopy)
HPLC (high performance liquid chromatography) in conjunction with a variety of detection methods including IR (infra-red), photodiode array, ELSD (evaporative light scatter detector), MS (mass spectroscopy), and MS/MS (tandem mass spectroscopy)
HP-TLC (high performance thin-layer chromatography)
ICP/MS (inductively coupled plasma/mass spectroscopy)
Microscopy
MS (mass spectroscopy)
Testing Programs: Products are tested through CL's Product Reviews and its Voluntary Certification Program (previously known as CL's Guaranteed Testing and Ad Hoc Testing programs).
Product Reviews:
Product Reviews are CL's independent tests of multiple brands of products claiming to have the same key ingredient. Product Reviews have the following features:
Exclusively directed by CL.
Products tested are purchased independently by CL at the retail level (stores, mail order, online, etc.). CL does not accept product samples from manufacturers for Product Reviews and CL may select samples at any time during the year (to avoid sampling bias).
Products are selected by CL to reflect popular brands in the market as well as a selection of smaller brands.
Products are tested at nationally and internationally
recognized iIndependent commercial and academic laboratories
that are qualified and selected by CL based on their expertise
for the type of specific testing needed for each product.
These facilities carry various Federal (FDA, EPA, USDA, DEA)
and State licenses and accreditations and follow
good laboratory practice (GLP) protocols. Many of these
laboratories go beyond the basic requirements and have additional accreditations
by independent outside groups (ISO, A2LA, etc), participate in method validation
programs, and undergo regular proficiency testing evaluations to further demonstrate their analytical capabilities.
Blind samples (the identities of the products and exact label claims are not disclosed) are sent to the testing laboratories in order to eliminate potential bias. Any products not having passing levels of key ingredients or contaminants are re-tested in a second independent laboratory using similar methods and instrumentation. CL's expert research staff closely evaluates the work of these laboratories.
After a Product Review is completed, results for products selected for testing by CL are available online to subscribers. Products that have passed the Voluntary Certification Program (see below) are also listed in respective Product Reviews.
Brands that "Pass" may carry the CL Seal of Approval upon acceptance by the manufacturer of the CL Seal Use License Agreement (described below).
Product Reviews are repeated periodically (approximately every 24 to 36 months) for each product category. However, CL may re-test brands at any time. A change in a brand's test results will be reflected in CL's Web site and will affect eligibility for the CL certification seal.
Full reports of Product Reviews are available in Product Review Technical Reports sold by CL.
Policy Toward Manufacturers of Products that Fail to Pass CL Testing:
Manufacturers of products that fail to pass CL's testing may request a summary of CL's test results, product lot number, expiration date, and place and date of purchase for such product. This information is provided by CL at no cost within three business days of receipt of written request.
CL maintains reserve samples of all products that it tests. If a manufacturer of a tested product disputes CL's findings, CL will offer reserve sample for repeat testing by a third-party laboratory of mutual acceptance to the manufacturer and CL. The manufacturer will directly pay the selected laboratory. There is no charge by CL for providing and shipping the sample. CL and the manufacturer must each publicly announce results of the re-testing on their websites on a page accessible through links from their homepages.
Voluntary Certification Program: Manufacturers and distributors interested in the potential of having their products certified by CL, listed among the Approved Quality Products in CL's Product Reviews and bear the CL Seal may participate in the Voluntary Certification Program. Testing is conducted in the same manner as Product Reviews with test samples not accepted directly from the manufacturer.
There is a testing fee paid by the manufacturer and results are proprietary to the manufacturer. However, if a product "Passes," it may appear in CL's Web site listing of the respective Product Review with a footnote indicating that it was tested through the Voluntary Certification Program. A product that "Passes" is also eligible to carry the CL Seal of Approval upon acceptance by the manufacturer of the CL Seal Use License Agreement (described below).
Due to economies of scale, testing fees are lower for products that fall within a category about to undergo a Product Review. Manufacturers and distributors should contact lisa.sabin@consumerlab.com if they wish to be alerted to upcoming Product Review categories.
Multi-Label Testing Program: For manufacturers of private label and multi-brand products seeking to participate in CL's Voluntary Certification Program, CL offers the Multi-Label Testing Program option. Manufacturers must provide proof that the formulations are identical for all products and all sampled products must pass testing for products to be listed as Approved Quality.
Raw Material & Private Label Certification Program: Suppliers of ingredients to manufacturers may have their materials evaluated by CL using the same testing methods employed in Product Reviews. If the material passes testing, a Certificate of Approved Quality is issued to the supplier, who may use it in its marketing to clients and prospective clients.
Athletic Banned Substances Screening Program:
Manufacturers, sports associations, and others may have dietary supplements and nutrition products tested for substances that could result in an athlete being disqualified from competing in Olympic or other competition. The screening program includes testing for specific stimulants, narcotics, anabolic agents, diuretics, masking agents, and beta-blockers based on the Olympic Movement Anti-Doping Code or the codes of other sports associations. Such products can also be evaluated for their active ingredients using the same criteria and testing methods employed in Product Reviews. There is a testing fee paid by the requestor, to whom the results are proprietary. If a product "Passes," the requestor may have it listed on CL's Web site for the respective Product Review with information indicating the substance(s) for which it was screened. Passing products are also eligible to carry the CL Seal of Approval upon acceptance by the manufacturer of the CL Seal Use License Agreement (described below).
Custom Analyses and Consulting: Parties wishing to engage ConsumerLab.com's research staff to perform special purpose testing, analyses, or consulting should contact research@consumerlab.com. Examples of assignments include testing of material for clinical trials, expert analysis and opinion for litigation, and concept/product testing for new product development.
USE OF THE "CL CERTIFICATION SEAL" Brands that "Pass" Product Reviews, or the Voluntary Certification Program are posted on CL's Web site as having "Passed" the specific test performed. Manufacturers of brands that "Pass" may purchase a license to use the CL Seal of Approval on their product labels, packaging, promotion, and advertising according to parameters set forth in the CL Seal Use License Agreement. Such licenses expire upon established dates and automatically terminate if the product does not "Pass" any re-testing by CL. In order to continue to carry the CL Seal directly on product labeling, the product must pass retesting every twelve months.
KEY MANAGEMENT: Tod Cooperman, M.D., President Dr. Tod Cooperman is a noted researcher, writer, and speaker on consumer healthcare issues. Dr. Cooperman is also the Founder of PharmacyChecker.com (www.pharmacychecker.com), an evaluator of Internet pharmacies, and CareData Reports, Inc., a leading independent evaluator of consumer satisfaction with managed care (now a division of J.D. Power and Associates). Dr. Cooperman is a graduate of the Boston University School of Medicine.
William R. Obermeyer, Ph.D., Vice President for Research Dr. William Obermeyer joined ConsumerLab.com from the U.S. FDA (Food and Drug Administration) where he was a Natural Products Chemist guiding research activities of various natural products and educating the public, academia and industry on the safety and proper manufacture and testing of dietary supplements. Dr. Obermeyer is an internationally recognized authority on pharmacognosy (the science of natural products) and serves on the Executive Board of the AOAC Technical Division for Reference Materials. Dr. Obermeyer received his Ph.D. from the Philadelphia College of Pharmacy and Science.
Lisa K. Sabin, Vice President for Business Development Lisa Sabin joined ConsumerLab.com from Prevention Magazine where she was an Account Executive working with healthcare and consumer products companies. Prior to that, she worked for Hearst Magazines, in the Brand Development Department, managing the merchandising of products under the names of its publications, such as Popular Mechanics, Cosmopolitan and Esquire. Ms. Sabin is a graduate of Rutgers University with a degree in Communications.
OWNERSHIP, AFFILIATIONS, AND SOURCES OF REVENUE: ConsumerLab.com, LLC is a privately held company based in New York. It is not affiliated with manufacturers of health and nutrition products. Revenues are derived primarily from sales of online subscriptions. Revenues are also derived from sales of books, survey reports, advertisements on its Web site, Voluntary Certification Program fees, and license fees from the re-publication of its proprietary information and authorized use of the CL Seal of Approval.
PUBLIC COMMENT: CL welcomes input from any interested party (e.g., consumer groups, retailers, healthcare professionals, academic and commercial researchers, manufacturers, government agencies, trade groups, etc.) in its testing policies and procedures. Comments and questions should be submitted electronically to info@consumerlab.com.
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