BSCG puts out advisory list of ingredients to augment FDA effort
BSCG’s action comes on the heels of the US Food and Drug Administration’s publication in April of an advisory list of ingredients that do not appear to be lawfully marketed in dietary supplements. The agency also announced the creation of a rapid response capability to more quickly alert consumers to the presence of these type of ingredients in the market.
FDA list didn’t go far enough
While that action was welcome, FDA’s list itself contained only four ingredients. Those are andarine, higenamine, hordenine and 1-4,DMAA. Oliver Catlin, president and co founder of BSCG, said his company, which tests hundreds of products a year, wanted to give more visibility to other ingredients that play in the penumbra of legality but might not rise yet to the official FDA enforcement level.
“We are constantly operating in these gray areas trying to figure out what’s legal and what’s not,” Catlin said. “We thought the FDA list was not sufficient. We have long wanted to help clarify which ingredients are on which side of the argument.”
Catlin said that questionable ingredients that do not appear lawful are a major problem for responsible members of the supplement industry. These ingredients can have uncertain safety profiles and can bring adverse side effects and create health and safety problems or lead to positive drug tests. But Catlin said he believes that the supplement and nutrition companies that peddle such ingredients represent a small fraction of the industry.
These pharmaceutical or synthetically derived ingredients, however, compete with legitimate dietary supplements, affecting the market and consumer demand. Since these ingredients are often labeled as dietary supplements, Catlin said the consumer may simply be unaware that what they are taking is actually a drug or a substance that otherwise does not fit the legal definition of a dietary supplement.
BSCG’s Dietary Ingredient Advisory List contains the four ingredients on FDA’s list plus many more. The list has a section on what constitutes a dietary ingredient, the definition lifted from DHSEA. It also includes more information on some ingredients that might be of more complicated provenance.
For example, for hordenine (which is also on the FDA list) BSCG’s list has this to say:
“The synthetic chemical hordenine does not appear to be a legitimate ingredient. However, hordenine is naturally present in cactus species, barley and other plants. Natural extracts of plants that contain hordenine may be legitimate, so this should be considered further.”
List includes nootropic ingredients
The list contains many of the stimulant-like ingredients that have been showing up in products marketed as dietary supplements. It also contains a lengthy list of nootropics, which are sometimes marketed as ‘smart drugs.’
“We don’t try to make up our own opinions on things. This is all based on the science,” Catlin said. “The difficulty with some of these ingredients is there can be and have been different opinions about whether some of these ingredients may qualify as legal or not,” Catlin said.
The list is freely accessible to industry and the public and may be viewed here.
