Quality Criteria / Standards:
The FDA’s 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, “blanks”, 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.
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 CL’s 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 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 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 and CL using a mutually acceptable test method. The manufacturer will directly pay the selected laboratory. There is no charge by CL for providing and shipping the sample. Prior to re-testing, the manufacturer 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.
