By now the public–and increasingly the investment and publicity community–is becoming aware of the growing electronic cigarettes/vape phenomenon. The benefit advocates fall into very different camps: some tout a safer smoking experience without ingesting well-known carcinogens; others promote greater flavor and nicotine dose variety than just “burning one”; then there are the cool riders on the wave of offering the “new thing”. While the potential health and social risks of the new process remain largely unstudied, there is already a commercial momentum with which to be reckoned. It now includes the beginning of Big Tobacco’s potential morph into becoming large scale ingredient suppliers for electronic cigarettes, when not still protecting their original interests as long as possible. At the grass roots level, retail storefronts are multiplying and e-liquid and equipment manufacturers abound and expand.
We in FDA GMP compliance diligence notice some interesting trends. People from the industry are coming to us with questions. And not just anybody; we notice the most interest from the domain veterans (those with 3 or more years experience qualifies), members of the emerging e-liquid trade organizations, and anyone else with a vested yet altruistic concern for the integrity of the industry to do it right from the start. We see the most extended GMP related conversations from those most concerned with the impact of pending FDA regulations and want to be best prepared to comply with whatever comes down.
The dietary supplement people we work with provide some resonant lessons for the e-cigarette group; they are largely fragmented but expanding very quickly, and we have seen dubious standards in benefits claimed, as well as manufacturing and business operation, sometimes with tawdry hype that does not sit well with the more professionally-minded producers in the realm or intelligent consumers. Dietary Supplements became GMP mandated, and the purveyors of hokum, the corner cutters, and the makers of adulterated or questionable merchandise were quickly exposed by their appearance on the warning letter list from the ever expanding FDA. Meanwhile many firms took the directive seriously and struggled to understand just what this notion of compliance was in order to avoid this.
Dietary supplements, however offered, are health related; the “new smoking” differs by being more leisure and entertainment, and could find itself commercially warp-scaled before it is understood by consumers and the health community. In order to grow and survive in this treacherous scenario, the e-cigarette/vape people need to do two things: first, ensure the quality of their products across the board; second, provide unambiguous, detailed documentation on procedures and production records that proves they are doing so. The GMP guidelines do this now, and are here today; the most prescient in the industry see them as offering the best possible existing guided path to the self-discipline that the still-new domain so desperately needs.
So we urge the regulatory authorities to require GMP compliance in the e-cigarette industry quickly to protect both itself and its consumers; the commercial juggernaut is in motion, now; many leaders are already taking control for the long term; and since it is certain that some brand of regulatory position will be in place soon, incorporating the GMP requirements into the e-cigarette business could prove the deciding survival factor for many.
InstantGMP™ offers many solutions for manufacturers of Dietary Supplements and e-Cigarette liquids.