The self-affirmed GRAS (Generally Recognized as Safe) process has long been a standard pathway in the food and dietary supplement industries. However, commentary by United States Secretary of Health and Human Services Robert F. Kennedy Jr. has placed this system under scrutiny.
Kennedy has argued that the current self-GRAS framework may be too lenient, allowing companies to independently determine ingredient safety without sufficient oversight by the U.S. Food and Drug Administration, a situation he believes could pose a potential risk to public health.
In response, Kennedy and FDA have begun exploring possible reforms to the self-GRAS pathway, including the possibility of more stringent FDA involvement in reviewing the safety of food and supplement ingredients. If such regulatory tightening occurs, ingredients that have achieved FDA-reviewed GRAS status will stand out as significantly more credible and reliable.
Kaneka Probiotics’ Lactobacillus plantarum DR7® Achieves FDA GRAS Status, Ensuring Safety and Regulatory Compliance
At Kaneka Probiotics, we have embraced rigorous standards when it comes to product safety and regulatory compliance. We are proud to announce that our probiotic strain Lactobacillus plantarum DR7® has recently received a “no questions” letter from the U.S. Food and Drug Administration in response to our notification, affirming the safety of DR7 for use in conventional foods, allowing formulators to harness its notable benefits on the gut-brain axis with confidence (GRAS Notice No. GRN 001205).
FDA notification of GRAS status requires a company to submit detailed evidence supporting the safety of an ingredient under its intended conditions of use. This includes toxicological studies, human clinical data where available, and expert consensus from qualified scientific panels. For L. plantarum DR7®, the FDA had no questions regarding the conclusion that the strain is safe for use in conventional food categories — a significant milestone that reflects our commitment to safety and transparency.
Meeting today’s standards and tomorrow’s expectations
As the regulatory landscape continues to evolve, Kaneka Probiotics is committed to ensuring our products meet not only today’s standards but also tomorrow’s expectations. Our FDA-reviewed GRAS status for DR7 underscores our dedication to delivering scientifically validated, responsibly regulated solutions for the health and wellness market.