Documented Cases of Toxicity
from Natural Products
What Is Toxicity And How Is It Determined
Quality Verification
Dietary Supplement
Health & Education Act of 1994
 


NATURAL PRODUCT QUALITY ASSURANCE --- WHO CARES?


by Enrico Liva, RPh, N.D.
President of ViTAL NUTRIENTS

Naturopathic physicians have a long history of prescribing natural products for themselves. their families and patients. I am one of them. Several years ago I observed that while many of my patients improved from the products I prescribed a significant number of them did not. I often wondered if the treatment failure I saw was truly treatment failure (not every body responds) or if the failure was the cause of inconsistent or poor quality. I began investigating two things 1) exactly what guidelines have to be followed to make a high quality botanical or natural product, 2) which of the professional product companies I'd been familiar with followed those guidelines. I spoke with the FDA, USP, NNFA, AHPA, (American Herbal products Association) and read their guidelines. Once I was comfortable with the information I started to tactfully ask some of the companies I'd purchased product from for years if they followed and performed what was necessary to assure the quality of their products. I was dismayed, surprised and somewhat shocked that most did little or nothing. In fact, I learned that the industry at large is not overseen or held accountable by anyone or any agency to any standard of quality assurance. There is a lot of talk about quality assurance but not substance. Each company does as they please and nobody is the wiser.

Natural product manufacturing companies ask you to trust their quality. They believe that the raw materials purchased from their suppliers are tested in some manner and are therefore authentic, However, most natural product manufacturing companies do no testing whatsoever and rely solely on the certificate of analysis provided to them by their raw material supplier. A significant number, if no a majority of raw material suppliers and nutritional supplement manufacturer do no independent or in house testing for confirmation of their raw materials or finished products.

There currently is no oversight body that makes sure natural product companies comply with either the already in place FDA Food GMPs (Good Manufacturing practices) or the proposed FDA GMPs for nutritional supplements (sooner or later the government is going to step in and regulate the industry). Trust in not enough to rely on. The industry is not trustworthy. The chain of events needed to product quality natural products is too long to "trust" it will happen with consistent integrity. A standard already exists (proposed FDA GMPs for nutritional supplements). Now is the time to hold suppliers accountable to follow those standards only. Everybody must follow the same map. Otherwise we again have inconsistently and some level of chaos. As an example, one popular professional products company has recently advertised that they have developed a new "gold standard" for testing product quality. They are going to test finished product only vs. the "old" method of testing raw material when it comes in. This is an untrue (as it is not a new gold standard) and ridiculous assertion (for many reasons), but the uneducated professional will probably believe it.

I and my practitioner colleagues have "assumed" and "trusted" that our suppliers were performing the due diligence and quality assurance necessary to produce consistent high quality product. we have been duped for years.

Until the government steps in it is up to the individual practitioner, store, or clinic to educate themselves about quality manufacturing guidelines and hold their individual suppliers accountable for following those guidelines. The goal is to choose natural product suppliers that product a uniform, high quality, consistent, pure, finished good according to an already established and accepted guideline. This helps obtain a higher clinical response and minimizes treatment failure that may be due to poor, inconsistent quality.