food supplements

DNA barcode testing of supplements in US by Izabela Tanska

10 months ago, New York State Attorney General’s (hereinafter, “AG”) office commissioned a DNA barcode test of herbal dietary supplements. The AG’s office states that the tested products didn’t contain what was declared on the label. Moreover, the supplements also contained some food ingredients that were not declared on the label.

In a study of 18 devil’s claw supplements, the New York Botanical Garden found that for the 16 supplements for which DNA could be identified, all contained zeyheri, either by itself (81%) or mixed with procumbens (19%).

In September AG announced that that his office issued letter demanding that 13 dietary supplements manufacturers cease and desist from the sale, distribution, or marketing of adulterated or misbranded "devil's claw" supplements. The letters are based on a study from the New York Botanical Garden that used an advanced DNA barcoding technique to conclude that the devil’s claw supplements from these manufacturers contained a cheaper related species (Harpagophytum zeyheri) that is considered less desirable.

It is required by federal regulation to identify plant species using the common name standardized in the trade publication, Herbs of Commerce. Most product labels for the supplements tested by the New York Botanical Garden also explicitly referred to the ingredient by its Scientific name, Harpagophytum procumbens.

The companies were requested to take some actions compensating consumers who purchased the adulterated supplements, and to reform their approach to quality control.  


DMBA in Dietary Supplements by Sebastian MELCHOR

DMBA is labeled as a dietary ingredient in some products marketed as dietary supplements. However, the FDA is not aware of any information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994. As a result, for dietary supplements that contain DMBA to be lawfully marketed, one of the following must apply:

  1. the product containing the dietary ingredient must contain only dietary ingredients that have been present in the food supply as an article used in food in a form in which the food has not been chemically altered, or 
  2. there must be a history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended in the product labeling, will reasonably be expected to be safe; and prior to bringing the products to market, the manufacturer or distributor must notify FDA of the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably expected to be safe.

Because neither of these conditions has been met by those marketing products that contain or are labeled as containing DMBA as a dietary ingredient, the FDA considers these dietary supplements to be adulterated.

DMBA is also known as:

  • 1,3-Dimethylbutylamine
  • 2-Amino-4-Methylpentane Citrate
  • 4-Amino-2-Methylpentane Citrate
  • 4-Amino Methylpentane Citrate
  • Amperall
  • AMP
  • AMP Citrate
  • 4-AMP Citrate
  • 4-Methyl-2-Pentanamine