The Origins and Intent of the GRAS Exemption
In 1958, Congress passed the Food Additives Amendment requiring FDA pre-market approval for new additives but included an exemption for substances 'Generally Recognized as Safe' (GRAS). This was intended for common ingredients with a history of safe use like salt, vinegar, and flour, to avoid burdening the FDA. GRAS status could be based on common use before 1958 or scientific procedures recognized by experts. The goal was to differentiate well-established safe substances from novel chemicals needing review.
How the GRAS System Became a Loophole
The GRAS exemption has significantly evolved. In 1997, the FDA introduced a voluntary notification system, allowing companies to make their own GRAS determinations without mandatory FDA notification. Companies are only 'encouraged' to submit findings. This shifts responsibility for safety from a public health agency to the companies profiting from using the substances.
Here is how this process can unfold:
- A company hires experts, potentially creating a conflict of interest, to review a new chemical's safety data.
- If the panel deems the substance safe, the company can declare it GRAS.
- The company can voluntarily submit a GRAS Notification to the FDA or use the ingredient without any federal oversight, known as 'secret GRAS'.
- If the company submits a notice and the FDA raises concerns, the company can withdraw the notice and still use the ingredient.
The Rise of Secret Additives and Health Concerns
This lax oversight has consequences. Since 2000, nearly 99% of new food chemicals entered the market via GRAS, not through traditional FDA approval. Because notification is voluntary, the FDA may be unaware of new chemicals until they are already in food products.
This system allows the food industry to essentially decide what is safe for consumers, leading to concerns about potentially unsafe or poorly tested ingredients with unknown long-term effects.
Comparison of GRAS vs. Traditional FDA Approval
| Feature | GRAS (Generally Recognized as Safe) | Traditional FDA Food Additive Approval |
|---|---|---|
| Initiation | Determined internally by the manufacturer, sometimes with external consultants. | Initiated by a food additive petition submitted to the FDA. |
| Review Body | A panel of experts assembled by the manufacturer. Potential for conflicts of interest exists. | Full scientific review conducted by FDA scientists and regulators. |
| Notification | Voluntary; companies are not required to notify the FDA. | Mandatory pre-market approval before the substance can be used in food. |
| Process Duration | Can be completed quickly by the manufacturer. | Takes several months to complete the formal review process. |
| Public Transparency | Low. Determinations can be made secretly without public disclosure. | High. The process is publicly documented, and the scientific basis is reviewed. |
| Oversight Level | Self-regulation by the industry, with limited FDA involvement. | Direct regulatory oversight by a federal agency. |
Efforts to Reform the System
Concerns about the GRAS loophole have led advocacy groups like the Center for Science in the Public Interest (CSPI) and Earthjustice to petition the FDA for reform. Legislation has been proposed to increase transparency and close the 'secret GRAS' pathway, such as requiring reporting of GRAS substances. Advocacy groups urge the FDA to mandate notification and set stricter standards for expert panels. Despite these efforts, comprehensive reform is slow.
What Consumers Can Do
Consumers can become informed label readers, paying attention to ingredient lists in processed foods which are likely to contain GRAS additives. Vague terms like 'natural flavor' can sometimes hide self-determined GRAS chemicals. Resources like CSPI's Chemical Cuisine database can help research additives. Choosing whole foods minimizes exposure to potentially untested additives.
Conclusion
The GRAS exemption, meant for common ingredients, has become a significant loophole for manufacturers, allowing self-certification and bypassing FDA scrutiny. This raises serious questions about food safety. While the FDA could strengthen oversight and legislation is being pushed, the system largely depends on industry integrity. Consumer awareness, advocacy, and legislative action are vital to address the loophole and prioritize public health.
What is the loophole for food additives? The GRAS System Explained
The full explanation of the GRAS system and its implications can be found on {Link: cspi.org https://www.cspi.org/cspi-news/how-food-companies-sneak-new-ingredients-past-fda} and {Link: cspi.org https://www.cspi.org/resource/how-do-new-substances-enter-us-food-supply}.
