The article, published in the March 2014 edition of the journal Agricultural Research, is based for the most part on a 2012 study conducted by two Agricultural Research Service scientists that found a number of extracts and finished products based on the popular weight loss botanical African Mango had little or none of the actual material in them.
In that study, published in the Journal of Agricultural and Food Chemistry, USDA chemist Pei Chen and assistant Jinghao Sun studied African Mango supplements and found that none of the labels provided accurate information.
“All of the labels of African mango dietary supplement products sold in the United States list African mango seed extract as the major ingredient,” Chen said. Chen and Sun conducted studies to find out whether the supplements contain what they say they contain.
The pair first tested a sample verified by the United States Pharmacopoeia to obtain baseline date using a ultra high-performance liquid chromatography-mass spectrometry method. Then they compared those findings with tests on three extracts purchased fron China and five supplement bought on the Internet. The results? One of the supplements contained trace amounts of the state extract. The other four and all of the three extracts contained no African Mango at all.
Question of identity
As often is the case with research into botanical ingredients, the identity of the material the researchers studied was hard to determine, said Stefan Gafner, PhD, chief scientific officer of the American Botanical Council.
“There are a number of issues here. First, the products analyzed by the USDA were all purchased either directly from China, or from Internet distributors in the USA. For a researcher, this is probably the best way to find non-compliant products, but as a consumer, the purchase of dietary supplements off the Internet, especially non-reputable sources, may not be the best strategy,” Gafner told NutraIngredients-USA.
“It’s not clear at this time as to what extent these ingredients and products represent the totality of the seemingly growing market for this ingredient,” said Mark Blumenthal, founder and executive director of ABC.
“Second, there is a lack of information (or even a lot of misinformation given the confusion between African mango [Irvingia gabonensis] and the much better known mango [Mangifera indica] fruit on this product, including accepted quality standards, which makes it difficult for a consumer to pick the right product. Therefore, the consumer needs to do some research about the product and the company ahead of purchasing a new herbal product,” Gafner said.
The fact that the Chinese material was noncompliant again raises the issue of how to assure reliable ingredients from that country, which accounts for an ever-growing share of the botanical ingredient supply market. In order to be sure, there is no substitute for adequate investment and for paying a realistic price, said Jim Schultz, CEO of GWI, a La Mirada, CA-based ingredient supplier that specializes in Chinese ingredients. The company has made a big investment in a lab located in China to verify the indentity and quality of ingredients prior to shipment.
“The reality is that it does cost extra time and money for suppliers to source products, test them and ensure that customers actually get the real product. Customers need to value quality and the various value added investments that distributors perform to ensure they receive the products that meet their expectations,” Schultz said.
“In addition, we must continue to challenge and collaborate from both sides—suppliers as well as supplement manufacturers. We often hear the demand for high quality ingredients, however, some products are still sold for an unrealistically low price – you get what you pay for most of the time. It makes one wonder about how manufactures could request such a low price, when the quality on the raw material side will suffer,” Schultz said.
Thorough testing a must
In the recent tide of GMP enforcement, FDA has made it clear that it will emphasize the need for thorough identity testing. Recent warning letters to manufacturers have mentioned this deficiency time and again.
“So for manufacturers, the only way to avoid adulteration is by having a thorough testing program. Recent FDA enforcement actions have shown that companies selling adulterated and frequently fraudulent materials will be caught and may be prosecuted,” said ABC’s Gafner.
“Finally, organizations like ABC and its partners, the American Herbal Pharmacopoeia and the National Center for Natural Products Research at the University of Mississippi through their Botanical Adulterants Program can raise the awareness of issues of economically motivated adulteration and educate the members of the industry, practitioners, and consumers about the occurrence of adulteration and inform how to make better choices in regard to herbal products,” he said.
Loren Isrealsen, president of the United Natural Products Alliance, said the issue was not new and was unlikely to go away soon.
“We have and will likely continue to see lack of compliance (quality and claims substantiation) in the weight loss arena. This is one of the thre areas (weight loss, ED products and steroid / stimulants) that remain a challenge for the historic dietary supplement industry and the regulators,” he said.