Re-Evaluating Additives on the GRAS List

One suggestion that came out of the workshop was periodic reassessment of consumers’ exposure to GRAS substances. Circumstances under which participants would recommend a toxicity re-evaluation include:

• Significant dietary changes
• FDA receives a petition for a new use of an approved food ingredient or additive
• New toxicological information becomes available
• Changes are made in manufacturing and sourcing of the ingredient that could affect its identity
• Improved measuring tools are available
• Congress or an international regulatory body questions the safety of a substance

In the case of BVO, dietary exposure in at least one population has increased dramatically. “Gamers,” or teens who play video games hour after hour, use sodas to give themselves the energy boost they need to stay awake and focused. And according to the Pew Research Center, nearly every U.S. adolescent plays video games. Serious gamers who play for six, 10, or 12 hours often drink a 20-ounce soda every hour. When you do the math you discover that a 20-ounce soda every hour over eight hours adds up to more than 4.7 liters. This booming market has not gone unnoticed by soda manufacturers. In fact, one recently launched video game partnered with Mountain Dew, rewarding players with points for drinking more of the soda.

This level of exposure to bromide can be dangerous. Emergency rooms have reported cases of headaches, fatigue, memory loss, and lack of muscle coordination as well as skin ulcers and swelling after extreme bromide exposure, along the lines of 4 to 8 liters of citrus-flavored soda per day. This amount is not atypical for many video-game-loving teens.

Another factor that might demand a second look at an ingredient is new technology that can yield more complete, more accurate toxicity data. One such breakthrough is the Toxicology in the 21st Century, or Tox21 program, a collaboration of the National Institutes of Health, the FDA, and the Environmental Protection Agency. The goal of Tox21 is to improve toxicity assessments in order to rapidly and efficiently predict which compounds can cause adverse health effects in humans. The program uses a high-throughput robotic system to test hundreds of thousands of chemicals using a diverse set of assays. It delivers reliable and reproducible results quickly that can be used to predict toxicity in humans and minimizes animal testing.

But some industry experts believe that rather than wait for lifestyle changes or technology advances to trigger a second look at toxicity, the FDA should have a standing schedule in place to periodically review GRAS substances in light of new technology or new information. Dr. Jacobson shares this viewpoint. “A periodic review, such as every 10 years, would help ensure that GRAS substances are not forgotten about.”

PepsiCo announced in January of this year that it would no longer use BVO in its Gatorade as a result of consumer feedback, although they will continue to utilize it in Mountain Dew and diet Mountain Dew. BVO will be replaced by the emulsifier sucrose acetate isobbutyrate, another GRAS substance.

Cowan-Lincoln is a science/technical writer based in New Jersey. She is a frequent Wiley-Blackwell contributor who has been featured in numerous publications. Reach her at [email protected].