nanotechnology

Nanotechnology is impacting our food, cosmetics and drugs!

Posted on August 3, 2014 · Posted in FDA Regulatory Updates

Did you know? Over 9,000 personal care and cosmetic products sold in the US contain nano-scale ingredients or ingredients that may contain a nano-scale fraction.

This means, those sunscreens, face creams, food or even OTC drugs contain small particles that impact the products function and possibly our cellular function in unknown ways.

As nanotechnology is becoming more common place in our cosmetic and drug products, safety factors need to be addressed. How are these particles truly impacting the human body?

The FDA is aware of such rapid advancement in the field of nanotechnology. AS of June, 2014 the FDA has issued 3 final guidance documents describing the process and regulations to be followed when nanotechnology is used in our cosmetics, food, drugs and devices.

Some of the key characteristics being regulated to protect our safety are listed here:

1. All cosmetics containing nanoparticles are required to test for toxicity (this includes how the product is absorbed), impurities and a full description of the physiochemical properties.

2. Products that meet the FDA described parameters (listed below) must be regulated and tested to nano-product standards.

• Whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1 nm to 100 nm);

• Whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer (1,000 nm).6

3. Substances may be added to food to accomplish a variety of technical effects in food. Examples of food substances that may be added for physical or technical functional effects include antimicrobial agents, humectants, flavoring agents, surface-active agents, stabilizers and thickeners (21 CFR 170.3(o)).
The physical and chemical properties of a food substance generally impact its technical effect and significant changes to a food substance’s technical or functional effect may result in conditions of use that are not authorized. Thus dietary impact and manufacturing controls must be documented as safe.

Keep in mind, current cosmetic, food, drug and device regulations must be followed to assure final product safety. These new nanotechnology rules add additional requirements for product manufacturing controls and final product distribution.

You can read more nanotechnology safety, testing and classifications specifics at the FDA website.

Photo: courtesy of Peter Goldmark and newsday.com, September 2012.