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Writer's pictureM. DuBose

The Regulatory Loophole in U.S. Food Safety: GRAS ingredients

The Hands-Off Approach Policy on GRAS Ingredients Has Compromised Consumer Health by Permitting Hazardous Additives in the Food Chain. Is Food Safety and issue?

The Regulatory Loophole in U.S. Food Safety. Blog presented by D.L. Newslow & Associates, Inc.

The United States food industry is a global powerhouse, providing a vast array of products to consumers. However, the safety of these foods is a matter of public concern, especially when it comes to the ingredients that are deemed safe for consumption. A significant legal loophole exists within the regulatory framework that governs these ingredients, particularly those classified as "Generally Recognized as Safe "or GRAS.


The GRAS Loophole

The concept of GRAS dates back to 1958, with the introduction of the Food Additives Amendment to the Food, Drug, and Cosmetic Act. This amendment required the U.S. Food and Drug Administration (FDA) to approve all new food additives before they could be used in products. However, certain substances that were "generally recognized as safe" by qualified experts were exempt from this rigorous review process. Originally, this exemption applied to common ingredients like vinegar and spices, but over time, the list has expanded significantly.


In 1997, a pivotal change occurred when the FDA allowed companies to self-determine the GRAS status of new ingredients without notifying the agency. This self-regulation, (hands off approach) has led to thousands of ingredients being added to the food supply without any government oversight, raising concerns about the potential for unsafe ingredients to be consumed by the public.


The Pressing Need for Oversight

Recent studies and articles, such as those published in the American Journal of Public Health, have highlighted the gaps in the FDA's oversight of GRAS ingredients. These publications reveal that many substances found in ultra-processed foods have entered the market without the FDA's knowledge, let alone its approval. The lack of transparency and accountability in the self-determination of GRAS status by food companies has been criticized by public health experts and consumer advocacy groups.


Efforts to Close the Loophole

In response to these concerns, there have been calls for legislative and regulatory reforms to close the GRAS loophole. Some proposed measures include requiring companies to notify the FDA of their GRAS determinations and to provide supporting safety data for review. Additionally, there is a push for the FDA to reassess the GRAS status of certain controversial ingredients that have already been incorporated into the food supply.


One such controversial ingredient is apoaequorin, a protein originally discovered in jellyfish and marketed for its supposed memory-enhancing properties. Despite safety concerns raised by the FDA, the ingredient continues to be sold as GRAS.

Are GRAS food being regulated properly for food safety?

In July, the FDA implemented a prohibition on following research indicating possible adverse effects on the heart and liver, as well as potential connections to neurological issues. This ingredient had previously been disallowed in the United Kingdom, the European Union, India, and Japan.


The Role of Companies and Consumers

The current system places the onus on food companies to conduct their own safety studies for GRAS ingredients. While the FDA encourages companies to voluntarily submit their findings, they are not legally required to do so. This self-regulatory approach has led to a situation where the safety of many ingredients remains unverified by independent government evaluation.


Consumers, on the other hand, are becoming increasingly aware of the ingredients in their food and the processes by which they are deemed safe. Public demand for greater transparency and safety assurances is growing, and this consumer pressure may be a driving force for change in the industry.


In Summary

The GRAS loophole presents a complex challenge to ensuring the safety of the U.S. food supply. While the self-determination of GRAS status by food companies offers flexibility and innovation in food production, it also poses risks that must be addressed. Closing the loophole will require concerted efforts from regulators, legislators, industry stakeholders, and consumers to establish a more transparent and accountable system that prioritizes public health.


For more detailed information on the GRAS loophole and its implications for food safety, readers can refer to the comprehensive press release from the Center for Health Law and Policy Innovation and the research articles from the American Journal of Public Health. These resources provide valuable insights into the ongoing debate and the steps being taken to ensure the integrity of our food system.


If you would like to learn more about GRAS food concerns, you can read some of the following resources listed below:

  1. "Unsafe Ingredients May Enter US Foods Via FDA 'Loophole,' Scientists Warn" - CHLPI.org.

  2. "How a Legal Loophole Allows Unsafe Ingredients in U.S. Foods – Press Release" - CHLPI.org.

  3. "How a Legal Loophole Allows Unsafe Ingredients in U.S. Foods" - NYU School of Global Public Health.

  4. "FDA's 'hands-off approach' to additives may allow unsafe ingredients in food" - NBC News.

  5. “Regulation of Added Substances in the Food Supply by the Food and Drug Administration Human Foods Program” – American Journal of Public Health

 

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