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Following clearance, all promotional claims must be truthful, non-misleading, adequately substantiated, and consistent with the cleared indications for use as stated in the device's FDA-cleared labeling

Under the FTC's substantiation doctrine, an advertiser must have a "reasonable basis" for its advertising claims before disseminating those claims

However, investor communications must clearly state that the Lumina CGM System has not been cleared by FDA and is not available for commercial distribution in the United States

Such materials must be clearly designated for internal use only and may not be distributed externally to healthcare professionals, customers, investors, or members of the public

All promotional claims must be consistent with, and supported by, the cleared labeling

Truthful and Non-Misleading Standard Every promotional claim made by Solstice regarding the Lumina CGM System must satisfy three fundamental requirements: (1) the claim must be truthful, (2) the claim must not be misleading, and (3) the claim must be adequately substantiated by competent and reliable scientific evidence