Regulations

The sale of OTC Medications is regulated in most countries.  The FDA has some detailed monographs on Cough and Cold remedies which, of course, do not have any provision for this device since it is a new approach for delivering vapors of TRPM* agonists.

But, as in the case of the OLBAS cylindrical menthol inhaler currently sold in the USA it is marketed as a “herbal substance” without any claims for treating coughs or cold symptoms.   Since it is possible to use all naturally occurring ingredients there should be no serious regulatory problems in marketing this device in a similar manner to what OLBAS has used.    Of course obtaining FDA approval as an OTC treatment would be the preferred outcome.

Most countries we have reviewed do have exceptions for “herbal or traditional medications”  and this device should qualify as such.

Since this is not a topical or oral medication it is simpler to control against any excessive intake of active ingredients and simply removing the device will remove any farther intake of vapors.  Since this device, when worn, is at 35C the vapors produced are simple to calculate in comparison with ingredients placed in hot water or other variable heat source at unknown distances from the nasal passages.

Accidental ingestion of active ingredients would be virtually impossible depending upon the containment package utilized.  Liquids or solids utilized in existing vaporizers either steam or electric powered are more open to end user mistakes or abuse.

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