NIST issues first herbal testing standards - for ephedra

By Jess Halliday

- Last updated on GMT

Related tags: Ephedra

Newly-issued standard reference materials for the quality control
of ephedra are still relevant, says the National Institute of
Standards and Technology's (NIST) - despite the plant having been
banned by FDA in 2004.

The reference materials - which cover powdered plant material, a ground solid oral dosage form and a protein powder - are part of a collaboration between NIST, FDA and the National Institute of Health's Office of Dietary Supplements that was initiated in 2001.

But two years ago this week FDA's final ruling banning ephedra-containing supplements came into effect, after the plant was linked with serious cardiovascular harm and fatalities.

In April 2005 a Utah court ruled that FDA had failed to meet its burden of proof that a daily dose of 10 mg or less of ephedrine alkaloids presents an unreasonable risk of illness or injury. It opened the way for Nutraceutical Corporation, the company that brought the lawsuit against FDA, to resume sales of supplements containing less than this amount per daily dose.

Although a very small number of low-dose supplements (not including Nutraceutical) seized on this as an overturn of the ban and began selling low-dose ephedra supplements through the internet, the supplements industry at large is not behind such reintroduction.

The main industry associations have urged their members not to consider a reintroduction until the legal position is clear. FDA stated that it is appealing the Utah ruling.

On announcing the new standards, NIST said that they are still relevant in spite of the ephedra ban, since they will assist manufacturers and researchers in ensuring that supplements are not contaminated with ephedra.

Michael Baum, public and business affairs at NIST, told NutraIngredients-USA.com that the materials are standard samples used to check the performance of an analysis technique.

He said that the NIST is not in a position to comment on the likelihood of ephedra adulteration.

They might also be used to detect other potentially quality problems, such as high concentrations of heavy metals, such as mercury, cadmium, lead and arsenic.

Moreover, the standards on ground solid oral dosage form also provides values for synphrenine or bitter orange, a botanical that is legally used in a number of ephedra-free weight loss products as its effects are similar; and the protein powder standard could also be useful for assessing caffeine, theobromin, theophylline and a number of nutrients.

The standards are intended to help manufacturers with quality control, and for researchers to measure the results of laboratory analyses up against.

NIST is planning to issue several other standard reference materials, on gingko biloba, saw palmetto, bitter orange, carrot extract, green tea, blueberries, and St John's wort.

Baum said that they development process is complicated and painstaking, and was therefore not able to give a timeframe any more specific than "over the next few years"​.

Other efforts to maintain quality standards of botanicals include AOAC's ongoing program to develop validated methods for supplement ingredients. This is intended, in part, as a means to boost consumer confidence without the need for heavy-handed regulation from the government.

Related topics: Suppliers, Polyphenols, Weight management

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