In 1994, Congress attempted to establish standards by passing the Dietary Supplement Health and Education Act (DSHEA).  DSHEA required the FDA to establish Good Manufacturing Practices (GMPs) for supplements modeled after those used in the food industry. It took 13 years before the FDA finally issued completed regulations on GMPs in 2007.

All dietary supplement companies, depending upon their number of employees, must comply with these guidelines no later than August 2010. The GMPs are a milestone for the industry, no doubt. Unfortunately, it is very unlikely that the FDA will be able to enforce them, or that manufacturers will voluntarily follow them.

Shortly after the GMPs were issued, the American Herbal Products Association (AHPA) petitioned the FDA to amend the guidelines, a major concern being that the GMPs put the burden of quality control solely on the manufacturers and not the suppliers of raw materials, nor the distributors of products.

The guidelines require manufacturers, not the FDA, to define quality specifications for their products and to then guarantee that the finished products meet those specifications. I do not believe this will assure any improvement in the quality of dietary supplements. In this “honor system,” a few companies will continue to make a good faith attempt, but most will continue to do a pitiful job. There are an estimated 1,200-1,500 natural product manufacturers in the US, now constituting a $22-billion industry. The majority do very little quality assurance testing.

The situation is eerily similar to the recent crisis in the financial industry. We relied on the mortgage, banking, and credit industries to regulate themselves in a free market and act in their long-term self-interest. That proved unrealistic, the good intentions sabotaged by greed and unscrupulous behavior.  Governments have had to intervene to establish better regulation.

Many raw materials for dietary supplements come from China and India where quality problems are notorious, such as melamine-tainted milk powder, heavy metal and drug contamination of herbal products. But not all raw materials from these countries are contaminated, and the quality problem is certainly not limited to those countries; problems have occurred in Germany, Spain, Mexico and here in the US.

Can we, as health care practitioners rely on existing third party GMP certification programs to guide us in choosing products in which we can have confidence?

Yes and no.  Certification from the Therapeutic Goods Administration of Australia assures that medicinal products meet the same standards required by the Australian pharmaceutical industry. Three US supplement manufacturers that I know of¾Thorne Research, Metagenics and Douglas Labs¾have achieved this TGA certification. The problem is that certification applies only to their products sold in Australia, which may or may not be different from the lines sold in the US.

How about ConsumerLab?  In 2005, the Council for Responsible Nutrition (CRN) filed a complaint with the Federal Trade Commission (FTC) requesting the agency take enforcement action against ConsumerLab.com, alleging the company was engaged in unfair and deceptive business practices.  CRN cited several examples of these alleged deceptions, including failure to disclose that it requires manufacturers to pay a fee for avoiding negative or gaining positive publicity associated with testing products.

CRN further charged that the name “ConsumerLab” suggests the company operates a laboratory, which it does not. For reasons that are still not clear, FTC did not take action on the complaint. To my mind, ConsumerLab’s value as a trustworthy guide for physicians is questionable at best.

Standard Operating Procedures (SOPs) are one of the most important components of quality control; they ensure that a sample is prepared and analyzed the same way each and every time. That’s good, as far as it goes, but SOPs do not guarantee purity or quality.  Unless a supplement manufacturer also verifies the purity of their raw materials, the only thing SOPs assure is  consistently mediocre products.

In addition to SOPs, we need systems that monitor the testing instruments and analytic methods used by the supplement companies. Labs need to procure and regularly analyze Laboratory Control Samples (LCS) side-by-side with each product sample. The data from the LCS can then be fed into charting software to look at run-to-run consistency of the data generated.

But no agency or regulation requires companies to institute LCS systems, so most companies have not.  It is a voluntary internal measure implemented by the best companies to ensure accuracy and precision.

Many supplement companies hire contract testing labs for their quality assurance work. Under the new GMP guidelines, these labs are openly subject to FDA audit as an extension of the manufacturer.  If the testing lab is not using scientifically valid methods and is not working under an SOP format, the manufacturer is liable, not the contract testing lab.

Most of the natural products I recommend and dispense are made by companies owned by people I have known and trusted for over 25 years. One such individual is Rick Liva, ND, RPh, the owner of Vital Nutrients. Rick has written a questionnaire for clinicians to use as a tool to determine manufacturer QA verification and certification processes.  It is available at http://www.imjournal.com/im/index.cfm?page=quality

Download the form, send it to suppliers and have them complete it to see if you are satisfied with their quality assurance.

I’m highlighting the problems in the natural products industry, but these issues are not unique. There are problems with quality control in the highly regulated pharmaceutical industry as well. But at least with regular inspection by trained FDA inspectors, these problems are more likely to come to light so they can be corrected.

As physicians, we do not have the time or the expertise to evaluate the vast number of natural products available to our patients. That is why I strongly believe the FDA needs to employ sufficient numbers of inspectors with sufficient training in natural product chemistry to enforce high quality standards in the same or better manner as they do the pharmaceutical industry.  Once FDA inspection reports are published, we will have a much better sense of which companies we can trust for high-quality products.

I believe that with the new Obama administration, there is a better likelihood of serious FDA regulation than with there has been during the Bush administration.

We may be unhappy with the FDA for many reasons, but without it, improving the quality of dietary supplements will remain a pipe dream.

Michael Traub, ND, DHANP, FABNO, past-president of the American Association of Naturopathic Physicians, practices on the Big Island of Hawaii. He is designing a study to compare the relative efficacy of an emulsified liquid vitamin D with encapsulated vitamin D. Interested parties may contact him at michaeltraub@earthlink.net. James, Michael’s son, is an analytical chemist with ChromaDex, a market leader in the creation and supply of botanical reference standards along with related phytochemical products and services.