Quality Standards for Vitamins

We have certain expectations as vitamin consumers, don’t we? We expect that the vitamin or supplement bottle that we purchase is full of pills that match the description on the label of the bottle. We also expect that each pill in the bottle will contain no dangerous toxins such as lead or mercury. We expect the pill was manufactured in a factory that was free of bacteria, fungi or viruses. We expect consistent quality from batch to batch. Glitzy marketing on TV, slick advertising in health food stores or beautiful web pages on the Internet don’t guarantee product quality. In addition, supplement quality can’t be guaranteed by price, so if it costs more it doesn't mean it's better made or safer. So how do you know what supplements to buy? Optimizing the levels of vitamins and supplements that we take can enhance the very essence of our life force energy. We can measure blood levels of some vitamins.

(Vitamin D for example) There are also ways of measuring the intracellular functional levels of vitamins and minerals using both urine and blood specimens. We have found that these analyses can guide us in correcting nutritional deficiencies that can affect a wide range of symptoms including fatigue, allergies, muscle pain and infertility.

This month we’re continuing our discussion about vitamins and supplements. We’ll review what the government standards are for supplement quality and we’ll learn how to choose brands of supplements.

Assumed to Be Safe Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, in order to define the FDA’s authority to regulate dietary supplements. DSHEA states that nutritional supplements and vitamins should be regulated as foods, meaning that they are assumed to be safe. (Contrast this with prescription drugs, which must undergo clinical trials for safety and efficacy before they’re sold to the public.) One thing that DSHEA did for vitamin manufacturers was to improve the growth of the industry! The number and size of vitamin companies grew 20% per year in the years following the passage of the law.

Although the boom in growth is currently smaller, most analysts still estimate a healthy 2 to 4% growth in the next few years despite our gloomy economic environment.

The FDA outlined Current Good Manufacturing Practices (cGMPs) in June 2007. Manufacturers have been given until 2010 to implement the guidelines. (The timing of cGMP phase-in is determined by the size of the manufacturer.) The cGMP guidelines require that nutraceutical companies must test their products and confirm that their labeling is reflective of the bottles’ content. Sounds ideal, doesn’t it? Unfortunately I (and many of my colleagues) see some major loopholes in the policy including 1) enforcement, 2) a lack of specific analysis methods and 3) the exemption of suppliers of raw materials.

Regulation Concerns An excellent review of these concerns is outlined by Rick Liva, ND, RPh in the Oct/Nov 2007 issue of Integrative Medicine. He notes that the FDA is responsible for inspecting about 80% of the U.S. food supply (the USDA is responsible for the other 20% such as meat, poultry and dairy). In reality, the FDA has historically inspected only about 1.7% of the 80%. This number is probably lower now because of cutbacks in government spending. But the real concern is in the area of the raw materials. Dr. Liva notes that in his experience anywhere from 30 to 50% of the raw materials that he tests have quality issues. There are so many examples of this - from black Cohosh products that don’t have the active ingredient in the finished product to mercury contamination in fish oil capsules to too much Vitamin A in a multivitamin, etc. It’s also clear that quality assurance testing is one of the first victims of corporate financial cutbacks.

My suggestion? Educate yourself about the company whose product you choose to buy. There is a questionnaire to send to manufacturers and/or suppliers about their quality assurance practices on the Integrative Medicine Journal's website (www.imjournal.com). In the menu bar on the left, click on “Quality Assurance” then click on “Manufacturer Quality Assurance Self-Audit Form.” Send the form to the supplier of your choice and see what you find out. (Or visit the factories if that’s possible!) I also subscribe to the monthly reports from Consumerlab (www.consumerlab.com), a private lab that tests over the counter vitamins and supplements. The first website is geared for clinicians - the second is one of many that is aimed at consumers. Both are tools to use and apply to your supplement choices.

There is no doubt in my mind that optimizing our nutrition with healthy, organic, whole food nutrition is the optimal path to health. Our vitamins and nutritional supplements can help us correct past mistakes and tweak our genetic tendencies. Choose carefully! Until next month, Be Well! Claudia Harsh, MD

Claudia E. Harsh, M.D., OB/GYN, is the Director of Integrative Gynecology at the Alliance Institute for Integrative Medicine, located in Kenwood. She and her colleagues use acupuncture and other forms of mind-body medicine to help people to reach their full potential.