What is G.R.A.S.?


GRAS: Generally Recognized as Safe

GRAS, an acronym for "Generally Recognized as Safe," is a significant designation given to substances used in food, food additives, or food packaging materials by the United States Food and Drug Administration (FDA). The GRAS status is supposed to be an assurance that a substance is considered safe for consumption or use in food-related products, without the need for a formal pre-market approval.
The concept of GRAS dates back to the passage of the Food, Drug, and Cosmetic (FD&C) Act in 1938 as part of efforts to protect public health and safety. Under the FD&C Act, substances that are considered to be GRAS are exempted from the stringent approval process required for food additives. This expertise-driven approach takes into account the considerable scientific knowledge and consensus surrounding the safety of certain substances.

Note: Our goods (e.g. cosmetics, shampoos) are not exempt from GRAS ingredients.

The Concerns

There are several reasons why Generally Recognized As Safe (GRAS) status has become a controversial topic in the food and beverage industry. Here are some bullet points highlighting the key factors contributing to this controversy:

  • Lack of transparency: One of the primary concerns surrounding GRAS is the lack of transparency in the process. Unlike food additives that undergo rigorous testing and evaluation by regulatory agencies like the FDA, GRAS determinations can be made by the food industry itself. This lack of independent oversight raises concerns about conflicts of interest and the potential for biased decision-making.

  • Conflicting evidence: The safety determination for GRAS substances often relies on published studies, historical use, and expert opinions. However, conflicting scientific evidence can lead to differing conclusions about the safety of a particular substance. This inconsistency raises doubts about the reliability and accuracy of GRAS determinations.

  • Failure to reassess: GRAS substances are typically evaluated at a specific point in time, and once deemed safe, they may remain accepted indefinitely without reassessment. Critics argue that the failure to regularly re-evaluate the safety of GRAS substances may prevent identification of potential risks that may arise over time or with changing conditions.

  • Undisclosed GRAS determinations: The "voluntary" nature of the GRAS notification process allows companies to bypass FDA review and approval. As a result, many GRAS determinations are not publicly disclosed, making it challenging for consumers and even regulators to know which substances have been granted GRAS status and for what reasons. This lack of transparency raises concerns about potential health risks associated with undisclosed GRAS substances.

  • Inadequate safety testing: While the FDA does provide guidance for conducting safety assessments of GRAS substances, the standards and tests required may be less stringent than those applied to food additives. This leniency in safety testing procedures raises questions about the reliability of GRAS determinations and the potential for unidentified health risks.

  • Industry influence: Critics argue that the GRAS system provides food and beverage companies with significant influence over the safety evaluations of their own products. This influence has raised concerns about the potential for biased decision-making and the prioritization of economic interests over public health.

It is important to note that these concerns and controversies surrounding GRAS do not necessarily imply that all GRAS substances are inherently unsafe. However, they highlight the need for increased transparency, independent oversight, and rigorous safety assessments to ensure consumer confidence in the safety of the food and beverages they consume.


Read The Ingredients Label!

I know we preach it daily but READ THE LABELS! Okay Okay, I’m sorry for yelling. It’s just, this simple habit will truly help you live a healthier life. FDA and programs like GRAS are not perfect, but we can educate ourselves to understand what is best for our bodies.

If you find yourself too busy to read each ingredient label or value your family time over constant research, we can help! Personal Shopper was designed so we can shop for you while we relax. We call you for a consolation to understand your needs, then we shop & deliver! More info here!