FDA Regulations Present an Imminent Threat to the Safety of the Public: Urgent Changes are Needed

While I have already argued that the FDA deeming regulations pose a long-term threat to the public's health because they will result in the removal of most vaping products from the market (so cigarette sales will continue uncontested), today I explain why these regulations pose a substantial immediate threat to the public's health.As of August 8, 2016, no new vaping products will be allowed on the market. Because the FDA considers virtually any change in a product to constitute a new product, this means that the deeming regulations will essentially "freeze" the vaping market as it exists on August 8. From that date forward, not only will companies not be able to introduce new products but they will also be unable to make changes in their existing products. Such changes would require a substantial equivalence (SE) determination (which is unlikely because few, if any products are similar to a predicate product on the market in 2007), an SE exemption (which is unlikely because the company cannot show that the product is essentially the same as a predicate product on the market in 2007), or a new product application (which will be prohibitively expensive for most companies). Moreover, these regulations will discourage companies from undertaking any revisions to their products. Several companies have already decided to freeze their inventory and discontinue their innovation research and development.To be clear, even small changes in products will not be allowed. For example, chang...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - Category: Addiction Source Type: blogs