Safety of Added Nanoceuticals Questioned

A new study published in the February 9 issue of Chemical & Engineering News reports that extremely tiny particles (about 1/5000th the width of a single human hair) are being added to an increasing number of dietary supplements. According to 3 week diet review, these substances, which reportedly have health-enhancing benefits, have an unknown safety record.

What Are Nanoceuticals?

Nanoceuticals are substances—in this case, nutrients–that have been reduced to the nanoscale through a physical process. This process does not change the chemical structure of the substance, but it does change its activity. For example, nanotechnology can make a nutrient more bioavailable, which means the body can better absorb and utilize it.

It is believed there are an estimated 44 nanoceuticals on the market in dietary supplements, and the number is expected to keep growing. These minute particles are of questionable safety, and because they are in dietary supplements, the Food and Drug Administration does not have the authority to review or evaluate these products before they go to market.

Are Nanoceuticals New Ingredients?

The FDA would have some leverage, however, if a definition was changed. A big question is whether nanoceuticals should be defined as new ingredients. According to the FDA, a new substance is one that has been altered chemically and has not been marketed previously. In the case of nanoceuticals, the substances are not chemically altered; they are just reduced to a miniscule, or nanoscale.

Supplement manufacturers say nanoceuticals are not new ingredients. However, some experts argue that nanoceuticals should be considered new dietary ingredients because they have new functions or properties once they are reduced to a nanoscale, even though they are not chemically changed. This is a question the FDA has not yet resolved.

Are Nanoceuticals Safe?

A number of consumer and watchdog groups, such as the Project on Emerging Nanotechnologies and the Consumers Union, are concerned about the possible health-damaging effects of these new substances and are urging regulators to make sure these nanoceuticals are safe. So far, anyone who uses dietary supplements that contain nanoceuticals have no way of knowing about their safety.

At least one regulatory expert has expressed concern about the lack of oversight by the FDA and the fact that nanoceuticals are entering the marketplace very rapidly. As the number of products that contain nanoceuticals grows, it will become increasingly difficult to monitor them.

Currently, the burden of safety is upon the manufacturers. Some experts are concerned that supplement makers are not conducting the tests needed to understand the impact of nanotechnology on nutrients or to determine whether these new nanoparticles are safe. If a supplement is found to be unsafe after it is available to consumers, however, the FDA can take action.

Benefits of Nanoceuticals

According to industry experts, some supplements use nanoscale substances to increase the ability of the nutrients to be used by the body. For example, phytonutrients (plant-based nutrients) found in berries, called polyphenols, are crystals and not readily bioavailable to the body. Therefore they need to be broken down to make them water soluble. This is where nanotechnology steps in, making an emulsion that allows the nutrients to be encapsulated in a form that the body can use more easily and effectively.

Nanotechnology is a rapidly emerging science, and the impact of nanoceuticals on human health is largely unexplored territory. It is an area that consumers of nutritional supplements may want to watch.