Independent laboratories and private companies are jumping into the dietary supplement rating game, hoping to bridge what many see as a gap in government oversight.

Web-based product reviews like ConsumerLab.com and SupplementWatch.com, as well as product labeling efforts like Paracelsian’s BioFIT, offer physicians and consumers new tools for distinguishing the good from the bad and the ugly among supplements.

ConsumerLab Highlights Winners

ConsumerLab (www.consumerlab.com) “attempts to fill the void in the FDA’s resources,” said William Obermeyer, PhD, formerly a botanical chemist at FDA, who is now vice-president for research of this web-based enterprise, which launched just over a year ago.

For each major herb or supplement category, the independently-owned ConsumerLab (CL) will analyze off-the-shelf samples up to 40 leading brands, to determine whether what is in the bottle measures up to what is claimed on the label in terms of substance identity and concentrations of index compounds.

CL also establishes minimums of active ingredients or marker compounds, based on available clinical data, US Pharmacopeia, German Commission E standards, and other data sources. For a product to “pass,” it must contain levels of index compounds within the ranges thought to be efficacious based on existing research.

CL conducts its own chemical analyses at its own expense, and then posts names of products that measure up to the defined standards. To date, CL has tested Calcium; Creatine; Asian and American Ginseng; vitamin C; SAM-e; Chondroitin/Glucosamine sulfate; and Ginkgo biloba. Currently under review are multivitamin products, Coenzyme Q10, Echinacea, Saint John’s wort, and vitamin E.

Products that “pass” are allowed—for a fee—to wear the flask-shaped “CL” seal on their packages. Among the companies currently using the CL seal are Enzymatic Therapies, PhytoPharmica, Schiff, and Naturally Vitamins.

ConsumerLab very politely refuses to name those products that fail to measure up. “We are not trying to publicize failures, but rather, shed light on good products,” said Dr. Obermeyer. The CL site accepts advertising, but true to its mission, only for products that meet CL standards.

The company recently developed a “CL Approved Quality Retailer” seal which it licenses to supplement retailers that pledge to identify products that pass CL testing and refuse to sell those that fail. The online retailer, eNutrition.com, is the first to become a CL approved operation.

SupplementWatch Scales the QA Mountain

SupplementWatch (www.supplementwatch.com), a small Utah-based consortium of nutritionists, dietitians and physiologists, has developed a point-scale to rate hot-selling supplements. This website names the diamonds, the dirt, and everything in between—and in no uncertain terms.

For each product category, SW’s reviewers cull medical, nutritional and botanical literature for relevant basic and clinical science, and then define standards for resonable health claims, phytochemical profile and product safety.

“We are trying to make the science understandable to active, well-educated, and highly motivated consumers,” said Julie Talbott, who founded SupplementWatch with her husband, sports nutritionist, Shawn Talbott, PhD.

SW rates products along five parameters: Claims (Are label claims reasonable? Are labeled amounts of active compounds enough to give intended effect?); Theory (Is there a plausible rationale for use?); Science (Are there supportive studies?); Safety (Are there possible adverse effects, contraindications, or safety concerns?); and Value (Is the expected benefit worth the retail price?).

On each axis, products are awarded up to 20 points, for a maximum score of 100. Those scoring above 90 get a “Try It!” rating; 80–90 fetches a “Recommended” grade. At the other end of the spectrum, for products scoring under 60, site visitors are told bluntly, “Don’t Waste Your Money.”

SW is not yet doing chemical analysis or other lab testing; Ms. Talbott said she hopes to undertake that effort in the future.

Of these two sites, CL’s approach is simpler: a product either measures up to chemical standards or it does not. SW’s scoring system, though based exclusively on past studies, lays out a quality spectrum, and the written product reviews give considerable detail on why a supplement earned the score it did. Together, the two sites provide a good starting point for sizing up supplements.

BioFIT Stresses Functionality

Systems like CL, SW and the National Nutritional Foods Association’s TruLabel monitoring system (see related story) are a good start; they can tell you if a product is what it says it is, whether it is well-made, if the claims are reasonable, and whether there is reason to expect physiologic effects. But they do not measure real-life therapeutic benefit. Short of costly clinical trials, nobody is sure what will.

Enter Paracelsian, a lab attempting to fill this knowledge gap with its Bio-Functional Integrity Tested (BioFIT) labeling program. BioFIT is the first functional validation system based on herb-specific bioassays.

The privately-held company is in the process of developing in vitro assays, validated to pharmaceutical standards, that measure an herb’s activity on chemical mechanisms relevant to the claimed health benefit. So far, the company has practical bio-assays for Ginkgo biloba, Ginseng, Saint John’s wort, Saw Palmetto, and Echinacea. To be deemed “BioFIT,” a product must demonstrate efficacy on two distinct assays.

In the case of Saint John’s wort, believed to have anti-depressant effects, BioFIT looks at serotonin and dopamine reuptake inhibition in neuronal cell culture systems. After dosing the cells with a particular company’s SJW product, Paracelsian “looks at tritiated serotonin or dopamine, and watches the reuptake by the neurons,” explained Bernard Landes, PhD, who was CEO of Paracelsian at the time these assays were developed.

Like CL, Paracelsian plans to license the BioFIT logo, for a fee, to products demonstrating bioactivity. To date, two companies, Extracts Plus, and R.P. Scherer have had products certified.

“Our acceleration will be directly in proportion to market demand,” predicted Jeff Morrison, Paracelsian’s director of business development. “Functional testing for bioactivity is going to be present, in one form or another, in the future of herbal medicine,” he told Holistic Primary Care.

But Mr. Morrison stressed BioFIT assays do not replace controlled clinical trials or other quality control measures. BioFIT certification does not guarantee that a product will produce the claimed therapeutic effect in vivo. It simply indicates that a product influences chemical systems physiologically relevant to the claimed benefit.

Paracelsian tests raw herbs as well as finished products, but the BioFIT seal is not “transferable.” A particular product made with certified raw materials is not automatically certified; final products must be individually tested.

Paracelsian also runs an online retail pharmacy for traditional Chinese herbal medicines (www.TCMPharmacy.com), selling a wide range of single herb and multiple ingredient products. When asked if these have been certified BioFIT, Mr. Morrison said it will take several years to develop functional assays for the various Asian herbs. It is, however, something the company plans to undertake.