After months (slash years!) of debate, the FDA has finally announced it’s proposed regulations for the e-cig industry. It’s been long speculated that the FDA would tighten down on electronic cigarette companies, and while most of the rules were to be expected, a few of them are sure to have negative long-term consequences. Surprisingly, some of the most worrisome regulation rumors didn’t come to pass. Marketing, flavors and Internet sales were unaffected; but just because you can still purchase your favorite e-liquid online, doesn’t mean you have nothing to worry about.
The U.S. Food and Drug Administration (FDA) proposed new regulations that would extend the agency’s authority to cover products deemed “additional tobacco products.” New products subject to the proposed rules include: e-cigarettes, cigars, pipe tobacco, waterpipe (or hookah) tobacco, nicotine gels and dissolvables.
The Proposed FDA Rules
Consistent with other regulated tobacco products, under the proposed FDA rules, makers of “additional tobacco products” would be required to:
- Register with the FDA and report product and ingredient listings;
- Only market new tobacco products after FDA review;
- Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole;
- Not distribute free samples;
- Impose age limits (with identification restrictions) to prevent sales to underage youth;
- Include associated health warnings; and
- Prohibit vending machine sales, unless in a facility that never admits youth.
The E-Cig Industry Should Be Concerned…
At first glance, most of the new regulations seem to make sense. Virtually everyone in the industry supports federal age restrictions, and most e-cigarette companies already disclose the ingredients used in their products. With as little as 3 to 5 ingredients, it’s ironic that some electronic cigarette makers have been criticized for not clearly disclosing all of their ingredients, yet traditional tobacco companies that use thousands of different chemicals are not forced to do the same.
More worrisome is the requirement that every new product be registered (and approved) by the FDA. Like all technology products, e-cigarettes are constantly evolving. If the FDA creates roadblocks every time a new advancement is made, WE’LL BE STUCK IN THE STONE AGE! With this type of power the FDA has the ability to tie up the e-cig industry in red tape, essentially dragging it’s feet and deciding who wins or loses. If the FDA’s track record on approving traditional tobacco products is any indication, it could be a long and bumpy road for e-cig companies.
From the CASAA Facebook page in response to the FDA’s announcement:
On its face, it appears that it is not as bad for consumers as it might have been, but there are still serious concerns. The FDA approval process is very complicated, and the details matter.
Still Some Hope?
But it’s not all doom and gloom. Overall the FDA is taking a more prudent approach than many expected. Marketing to adults has not been limited, our favorite e-liquid flavors are still available and if you’re 18 years or older you can still purchase electronic cigarette supplies online.
Rather than introducing abrupt and disruptive regulation without scientific basis, the FDA appears to be cautious and somewhat open-minded. One of the proposed rules actually allows e-cigarette makers to “prove” their claims of safety with scientific data, meaning the FDA is open to new research.
It’s important to note that the recently published rules are only proposed rules at this time. The next step for the FDA will be to open a docket for public comments, which will last for 75 days. You can be sure that the CASAA (Consumer Advocates for Smoke Free Alternatives) and SAFTA (Smoke Free Alternatives Trade Association) will be heavily engaged in the process, so be sure to follow (and join!) these organizations to help champion the rights of vapers.