Vindication of Black Cohosh Underscores the Need for Good Manufacturing Standards

Will the real Black Cohosh please stand up?

Once again, the critical importance of Good Manufacturing Practices (GMPs) for the dietary supplement industry has been brought to our attention, this time due to problems caused by bogus Black Cohosh.

Black Cohosh (Actaea racemosa, formerly Cimicifuga racemosa) is well known and widely used for alleviating menopausal symptoms. This herb has been under heavy scrutiny by the FDA and Health Canada for potential liver toxicity issues. In recent years, Black Cohosh products sold in Canada and Europe have been required to carry warnings about potential liver reactions due to several reports of liver toxicity in patients taking commercially available “Black Cohosh” products.

These reports have left clinicians familiar with Black Cohosh and it’s long history of safety scratching their heads.

Finally, Health Canada is beginning to shed some light on the issue. Last month, Canadian regulators reported that upon testing the actual products responsible for the liver toxicity reports, all three Black Cohosh supplement products were found to contain related herbs, but not Black Cohosh itself! Two other products have been identified as being unauthorized and their contents are as yet unknown.

Sounds like a case of “economic adulteration,” that is, substitution of cheaper herbs of similar appearance for more expensive ones, as well as lack of adherence to 100% identity testing which is mandated by dietary supplement GMPs. This investigation may finally exonerate Black Cohosh from these confusing allegations.

Ideally, the regulators’ first response to a new report of a severe adverse event associated with an herbal product (especially one with a long history of safe use) would be to validate the identity of the product in question, and then to perform a microbial, pesticide, and heavy metal analysis on samples of the actual product allegedly causing the problem.

Current GMPs in the US require that all plant ingredients sold here must properly be identified for genus and species as well as for potential contamination. Clearly there are gaps, omissions, and outright violations on the industry side. But as the Black Cohosh situation points out, the regulators are not really doing proper due diligence either.

This recent analysis by Health Canada has determined that authentic Black Cohosh was not, in fact, involved in the particular adverse events that led to the mandate for adverse event labeling. It calls into question earlier adverse event reports associated with this herb. Perhaps it is time to take a closer look at the liver toxicity cases that led to the ban of Kava Kava, another beneficial herb with a long history of safe use?

Rules of thumb for buying herbal supplements:

1. Make sure the product is manufactured in a GMP certified facility. Don’t assume. Companies with less than 20 employees are not required to be in compliance with GMPs yet, and most larger companies have not been inspected by the FDA for compliance.
2. Don’t be afraid to call and ask how a manufacturer ensures proper validation of genus and species: i.e. ask if they bring in whole plants and perform organoleptic identity testing or do they receive dried powders, which require sophisticated analytical equipment and methodologies. Keep in mind that when a manufacturer receives powdered plant material for encapsulation that it is much more difficult to properly identify genus and species of a plant. Botanical supplement makers that are not vertically integrated (ie, not growing and processing their own raw materials) should be able to vouch for the quality of their supplier and their suppliers’ manufacturing practices!
3. Ask what solvents are used in the plant extraction process and what is done to ensure absence of these solvents in finished product.

Botanical medicine is a vital part of integrative medical practice. To ensure safety and efficacy of botanical medicines in our patients and clinical trials, physicians must continue to advocate for transparency and accountability amongst our partners in the natural product industry.

I welcome your thoughts on this and other important issues in botanical medicine & natural health care.