The FDA has received requests to amend labeling regulation 21 CFR 101.93(d), which covers the DSHEA disclaimer under section 403(r)(6)(C) of the FD&C Act. This disclaimer states: ‘This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.’
The FDA is reviewing these requests, which propose removing the requirement for the DSHEA disclaimer on each label panel with a 403(r)(6) claim. This change could align with section 403(r)(6)(C) and reduce label clutter and costs. The FDA has rarely enforced this requirement and may propose a rule change if no major concerns arise from the review.
While the rulemaking process is underway, the FDA will exercise enforcement discretion regarding the DSHEA disclaimer on each label panel with a 403(r)(6) claim. However, the requirement to include and link the DSHEA disclaimer to each claim on the product label will remain enforced, along with other regulations of 21 CFR 101.93.
