## Facts

- A consumer was prescribed Zantac 150 (150 mg ranitidine), available only by prescription and costing more per equivalent dose than over-the-counter Zantac 75 (75 mg ranitidine).
- Seeking to substitute the cheaper over-the-counter product, the consumer contacted manufacturer-related sources.
- A hotline operator stated Zantac 75 and Zantac 150 were “not the same medications” and that two Zantac 75 tablets could not be substituted for one Zantac 150 tablet.
- A recorded hotline message stated that a person directed by a doctor to take prescription Zantac should not substitute Zantac 75.
- A website stated that if a physician has prescribed a medicine, a consumer should not substitute another medication and should ask the physician about changing medication.
- The consumer filed a putative class action under the Illinois Consumer Fraud and Deceptive Business Practices Act (ICFA), alleging the statements falsely implied the products were not substitutable in equivalent doses.
- The district court dismissed under Rule 12(b)(6), concluding Illinois law exempted the statements from liability; the consumer’s estate appealed.

## Issues

1. Whether the hotline and website statements were materially false or misleading to a reasonable consumer under the ICFA.
2. Whether the ICFA’s § 10(b)(1) exemption for conduct “specifically authorized” by federal or state regulators barred liability where the statements reflected FDA-authorized distinctions between prescription and over-the-counter uses.

## Decision

- The Seventh Circuit affirmed the Rule 12(b)(6) dismissal.
- The court held the statements, read in context, were accurate or non-deceptive as a matter of law because they communicated a medical caution against self-substituting prescription therapy without physician guidance.
- The court further held that, to the extent the statements reflected FDA-authorized prescription/OTC status and approved indications, the ICFA’s § 10(b)(1) regulatory-authorization exemption applied.

## Legal Principles

- An ICFA claim requires a materially misleading statement likely to mislead a reasonable consumer; statements reasonably understood as medical cautions may be non-actionable.
- Products sharing an active ingredient may still be “not the same” in a legally relevant sense where their FDA-approved indications and regulatory status differ.
- ICFA § 10(b)(1) bars liability for actions or transactions “specifically authorized” by laws administered by a federal or state regulatory body; conduct consistent with FDA approvals and labeling-related distinctions may fall within the exemption.
- At the pleading stage, courts may dismiss where the challenged communications are non-deceptive as a matter of law when considered in context.

## Conclusion

The court concluded that “do not substitute” communications about prescription Zantac and over-the-counter Zantac were not materially deceptive to reasonable consumers and, insofar as they mirrored FDA-authorized distinctions and warnings, were exempt from ICFA liability, warranting dismissal.


Bober v. Glaxo Wellcome PLC, 246 F.3d 934 (7th Cir. 2001)