FDA will temporarily stop enforcing a rule that requires the DSHEA disclaimer to appear on every label panel where a structure-function claim appears. While the agency considers revising the regulation, the disclaimer itself—and its connection to claims—remains mandatory.
For dietary supplement companies facing increased labeling scrutiny and lawsuits, the announcement offers clarity, but not immunity.
Why FDA Is Reconsidering DSHEA Disclaimer Placement
The shift reflects how supplement labels are actually reviewed in practice.
DSHEA allows supplement companies to make structure-function claims if they include a disclaimer stating the claim has not been evaluated by FDA and that the product is not intended to treat or prevent disease.
Later FDA regulations added a technical requirement: the disclaimer must appear on every panel where a qualifying claim appears.
In reality, FDA has rarely enforced that interpretation, even as labels became more complex.
In its December letter, FDA acknowledged that gap and questioned whether repeating the disclaimer across multiple panels truly improves consumer understanding—or simply adds clutter.
What FDA’s Enforcement Discretion Covers
The relief is narrow and specific.
FDA stated it will not enforce the requirement that the DSHEA disclaimer appear on each label panel containing a structure-function claim.
This discretion applies only while FDA considers whether to amend the regulation.
As long as the disclaimer appears on the label and is clearly linked to the relevant claims, FDA does not intend to take enforcement action based solely on placement.
The agency emphasized this is temporary, not a permanent rule change.
What Has Not Changed for Supplement Labels
Core DSHEA requirements remain fully enforceable.
FDA made clear that enforcement discretion applies only to disclaimer placement—not overall compliance.
Companies must still:
- Include the DSHEA disclaimer on the product label
- Clearly link the disclaimer to each structure-function claim
- Avoid disease claims or misleading language
- Ensure claims are truthful and substantiated
Where the disclaimer appears may be flexible for now. Whether it appears is not.
How Labeling Lawsuits Influenced FDA’s Decision
Private litigation pressure shaped the timing of this announcement.
In recent years, supplement companies have faced a rise in lawsuits and demand letters over technical DSHEA disclaimer placement issues.
Many focus on whether the disclaimer was close enough to a claim or repeated often enough across panels.
These cases often move forward even when FDA has never cited a violation.
FDA’s letter responds directly to that tension by signaling that multi-panel repetition is not a federal enforcement priority.
Why FDA Guidance Helps—but Doesn’t End—Lawsuits
Enforcement discretion does not bind courts or private plaintiffs.
State-law claims can still be filed, and judges are not required to follow FDA enforcement priorities.
That said, FDA’s position strengthens key defense arguments.
It supports the view that technical placement issues are unlikely to be material to consumers and that FDA is best positioned to interpret labeling requirements.
For companies already defending DSHEA-related cases, this guidance may influence motions and settlement leverage.
Why Companies Should Be Cautious About Changing Labels
Reduced enforcement does not equal reduced risk.
Until FDA formally amends the regulation, the placement rule still exists.
As a result:
- Removing disclaimers from secondary panels may still invite lawsuits
- Poorly linked disclaimers remain vulnerable
- Aggressive structure-function claims continue to draw scrutiny
For most companies, a targeted compliance review is safer than a full label redesign.
What a Future Rule Change Could Mean
A formal amendment could simplify compliance long term.
FDA has indicated it may propose removing the requirement to repeat the DSHEA disclaimer on every panel.
If finalized, the change would align the regulation with long-standing industry practice and reduce label congestion.
Rulemaking takes time. Until then, enforcement discretion serves as a temporary bridge.
Frequently Asked Questions (FAQ)
Is the DSHEA disclaimer still required?
Yes. FDA has not changed the statutory requirement to include the disclaimer on dietary supplement labels.
Can one disclaimer cover multiple claims?
FDA will not enforce the requirement to repeat the disclaimer on every panel, but the disclaimer must still be clearly linked to each structure-function claim.
Does this stop labeling lawsuits?
No. Private lawsuits may continue, but FDA’s position may weaken claims based solely on placement.
Is this a permanent change?
No. FDA described the enforcement discretion as temporary while it considers amending the regulation.
Juris Law Group Insight
Juris Law Group advises dietary supplement companies on FDA compliance, labeling risk, and litigation strategy.
Regulatory signals like this often influence enforcement and lawsuits long before formal rules change.
Key Takeaway
FDA’s enforcement discretion reduces uncertainty around DSHEA disclaimer placement, but it does not eliminate labeling or litigation risk.
This is an opportunity to reassess labeling strategy—not abandon compliance.
