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About ConsumerLab.com

OVERVIEW:
ConsumerLab.com, LLC ("CL") is the leading provider of independent test results and information to help consumers and healthcare professionals identify the best quality health and nutrition products. It publishes results of its tests in comprehensive reports at www.consumerlab.com. CL also conducts an annual Survey of Vitamin & Supplement Users. CLís 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 quality 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 3,400 products, representing over 450 different brands and nearly every type of popular supplement for adults, children, and pets.

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 FDAís Good Manufacturing Practices (GMPs) for dietary supplements allow each manufacturer to determine the quality standards and analytical methods it uses to evaluate the quality of its products. 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

Testing 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)

Laboratories:
Due to the range of testing methods needed to thoroughly evaluate products, tests other than initial disintegration analysis (which is performed by CL) are performed at nationally and internationally recognized independent laboratories. These labs are qualified and selected by CL based on their expertise for specific types of testing. CL's expert research staff closely evaluates the performance and work of these laboratories. This may include sending additional blinded samples (e.g., duplicates, ďblanksĒ, and well-characterized reference materials) within a group of test samples to monitor method performance.

These facilities carry various federal (FDA, EPA, USDA, DEA) and state licenses and accreditations, follow peer reviewed validated methods published by authoritative institutions such as USP (United States Pharmacopea) and AOAC (Association of Analytical Communities) International, and follow guidelines based on GLP (Good Laboratory Practice) protocols. Many of these laboratories have additional accreditations by independent outside groups (e.g., ISO and A2LA), participate in method validation programs, and undergo regular proficiency testing evaluations to further demonstrate their analytical capabilities.

To eliminate potential bias, the identities of product samples and their claimed ingredients are not disclosed to the testing laboratories.

Testing Programs:
Products are tested through CL's Product Reviews and its Quality Certification Program (previously known as the Voluntary Certification Program).
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. Results of CL's Annual Survey help guide product selection.
Any product not passing CLís quality criteria is re-tested for confirmation in a second independent laboratory using similar methods and instrumentation.
After a Product Review is completed, results for products selected for testing by CL are available online to subscribers. Products that have passed the Quality 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. When a newer Product Review is posted, it replaces any previous Product Review covering the same category of products and the older review is removed from the website. Product selection typically changes from review to review in order to sample currently marketed products and their most current formulations. At any given time, reviews of over 1,000 products are available on the CL website.
Full reports of Product Reviews are available in Product Review Technical Reports sold by CL.

Policy Toward Manufacturers and Distributors of Products that Fail to Pass CL Testing:
Manufacturers and distributors 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/distributor of a tested product disputes CL's findings with evidence supporting an error by CL, CL will offer reserve sample for repeat testing by a third-party laboratory of mutual acceptance to the manufacturer/distributor and CL using a mutually acceptable test method. The manufacturer/distributor will directly pay the selected laboratory. There is no charge by CL for providing and shipping the sample. Prior to re-testing, the manufacturer/distributor must agree that it will publicly announce results of the re-testing on its main website on a page accessible through not more than a single link from its homepage. CL will similarly publish the findings on its website.

Quality Certification Program:
Manufacturers and distributors interested in the potential of having a product certified by CL as Approved Quality and bear the CL Seal may request that the product be tested through the Quality Certification Program. Testing is conducted in the same manner as Product Reviews with test samples not accepted directly from the manufacturer. The Quality Certification Program is designed to help consumers identify additional high quality products on the market.

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 Quality 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 Quality 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.

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 Quality 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. Dr. Cooperman is a graduate of the Boston University School of Medicine and received his Bachelorís degree from Boston University with a major in Medical Sciences and a minor in Economics.

Mark L. Anderson, Ph.D., Vice President for Research
Dr. Anderson has over 16 years of experience in dietary supplement research in addition to 10 years of experience in pharmaceutical and biotechnology drug development. He has been actively involved in analytical testing, utilizing methods such as HPLC, ELISA, CPC, GC, GC/MS, SEC, IEF, LC/MS/MS and has developed and validated qualitative and quantitative assays in accordance with GLP/GMP regulations. Dr. Anderson has authored over 10 peer-reviewed publications in pharmacology and analytical chemistry and is an active member of AOAC International, serving as an elected member of the Executive Committee in the Technical Division on Reference Materials. He was previously the Director of Research & Development at Triarco Industries. Earlier in his career, Dr. Anderson held positions as Analytical Laboratory Director at Emisphere Technologies, Associate Senior Scientist at Purdue-Frederick Pharmaceutical Co, and a Clinical Laboratory Technologist in Toxicology at Metpath Laboratories. Dr. Anderson received his Ph.D. in Pharmacology/Toxicology from St. Johnís University.

Charles J Scally III, Vice President for Information Technology
Mr. Scally began his relationship with ConsumerLab.com as a consultant in 1999, creating the platform on which the ConsumerLab.com website is built. In 2011, he joined ConsumerLab.com full time to handle its growing IT needs. Mr. Scally has over 18 years experience in the IT field, beginning his career as webmaster for IBM at the Watson Research Center in Yorktown, NY. In 1999, he joined the IT team at Readerís Digest/QSP where he built the e-commerce platform for their fundraising division which processed over $100 million dollars for various schools and charities. Mr. Scally has a Bachelorís degree in Information Technology from Mount Saint Mary College and an Associateís degree in Electrical Engineering Technology from Orange County Community College.

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, Quality 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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