Big changes could be coming to the supplement industry. Robert F. Kennedy Jr. is pushing the FDA to do away with self-affirmed GRAS (Generally Recognized as Safe) status for food and supplement ingredients—a move that could send shockwaves through the industry.
Why does this matter?
Right now, an estimated 90% of supplement ingredients rely on self-affirmed GRAS status instead of going through an FDA-reviewed determination. (Source) If that process disappears, companies could be facing a whole new regulatory reality.
Understanding GRAS and Why It Matters
GRAS status allows food and supplement ingredients to bypass traditional FDA food additive approval if they are widely accepted as safe by qualified experts.
There are two ways to establish GRAS status:
1. FDA-Notified GRAS
Companies voluntarily submit safety data to the FDA. If the agency has no objections, the ingredient is publicly recognized as GRAS.
2. Self-Affirmed GRAS
Companies conduct their own safety reviews without FDA involvement, making independent safety determinations. These findings are often confidential, leaving regulators, consumers, and even competitors in the dark.
While self-affirmed GRAS offers efficiency and flexibility, it also raises concerns about transparency, accountability, and potential safety risks.
RFK Jr.’s Push for Change – What’s at Stake?
Kennedy’s call to eliminate self-affirmed GRAS could be a game-changer for the supplement industry.
If the FDA follows through, this could mean:
Mandatory FDA Review – Every new supplement ingredient would need FDA clearance before hitting the market, increasing regulatory oversight.
Increased Transparency – Companies would be required to disclose safety data, eliminating the secrecy surrounding self-affirmed GRAS determinations.
Delays and Added Costs – The regulatory process would likely become more expensive and time-consuming, potentially slowing down product innovation.
Legal and Compliance Challenges – Companies that have relied on self-affirmed GRAS may need to reevaluate their regulatory strategies to avoid enforcement actions.
What This Means for Supplement Companies?
For supplement manufacturers, Kennedy’s proposal could bring both challenges and opportunities. While increased FDA oversight may boost consumer confidence in supplement safety, it could also create significant legal and compliance burdens.
Companies should consider:
Reviewing Self-Affirmed GRAS Ingredients – Assess whether your ingredients meet FDA-notified GRAS standards.
Preparing for More Stringent Compliance – Updating internal regulatory processes now could prevent costly disruptions later.
Monitoring FDA Actions Closely – The agency has not yet formalized Kennedy’s proposal into a rule, but businesses should stay ahead of potential regulatory shifts.
Engaging FDA Compliance Experts – Working with an FDA compliance attorney can help mitigate risks and ensure that your products meet evolving regulatory requirements.
Bustos Law Group is an FDA compliance firm specializing in supplement compliance and GRAS ingredient compliance. Please call … or email info@bustoslawgroup.com for assistance.
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