Following up on my recent post on the FDA deeming e-cigarettes tobacco, I had the opportunity to speak with Colin O’Keefe of LXBN on the subject. In the interview, I explain exactly what the FDA has done and share my thoughts on how the Proposed Rule will impact the e-cigarette industry. Let me know your thoughts. […]
On April 24, 2014, the U.S. Food and Drug Administration (FDA) announced what some call a “long- awaited” proposed regulation that will impact the future of the currently booming e-cigarette industry. Currently, e-cigarettes are not a part of FDA’s purview and have no FDA oversight – FDA’s proposed rule intends to change this in a big way.
How is Tobacco Defined Currently?
Section 201(rr) of the Federal Food, Drug and Cosmetic Act (FD&C Act), (21 U.S.C. 321(rr)),as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), currently defines the term “tobacco product,” as ” any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product… “. The Tobacco Control Act permitted FDA to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco automatically as “tobacco product” under the FD&C Act. Section 901 of the FD&C Act gives the FDA leeway to include “any other tobacco products that the Secretary by regulation deems to be subject to this chapter” and therefore subject to FDA regulation under the FD&C Act.
“Deeming”
The FDA is proposing to “deem” products meeting the statutory definition of “tobacco product,” except accessories of a proposed deemed tobacco product, to be subject to the FD&C Act. The FDA proposed 2 options for public comment. Option 1 extended the definition of “tobacco product” in the FD&C Act to “electronic cigarettes, some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not […]
For those of you keeping up with the FDA Food Safety Modernization Act (FSMA), big changes are coming for those in the food industry. We have been keeping you up to date with blogs on updates to FSMA. We have even created an updated website on FDA to help you understand the vast requirements under the FSMA, as well as complying with FDA generally. If you are a foreign manufacturer, processor, packer, storer or holder of food products, you need a U.S. agent, and must register with the FDA – for more information, review www.FDA-USA.com.
The latest news is that the FDA has released the third Edition of the U.S. Food & Drug Administration (FDA) draft guidance titled “Guidance for Industry: Prior Notice of Imported Food Questions and Answers”. Prior notice is just what it sounds like, “notification to the FDA that an article of food, including food for animals, is being imported or offered for import into the United States in advance of the arrival of the article of food at the U.S. border.”
FDA is seeking comments on the draft guidance and addresses questions received since the publication of the second edition of the guidance in May 2004. The guidance also includes information related to the FSMA, which requires additional information to be provided in a prior notice of imported food submitted to the FDA. The FSMA included a new Prior Notice element, now the FDA requires a person submitting prior notice of […]
FDA has just released the 2013 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices.
Section 1003(h)(2)(A) – Number of import lines examined/sampled
Section 1003(h)(2)(B) – Number of import lines not examined/sampled
Co Authored by Omar Franco
Last night Congress voted to end the first federal government shutdown in seventeen years and avert a default on U.S. debt. The deal brokered between Senate Majority Leader Harry Reid (D-NV) and Minority Leader Mitch McConnell (R-KY) provides government funding through Jan. 15, 2014, at almost the same rate as in FY-2013 after automatic spending cuts. The debt limit would be extended through Feb. 7, 2014, if requested by President Obama. The legislation includes a mechanism to allow Congress to block the suspension through action on a resolution of disapproval. The Health and Human Services Department would be required to ensure that health-insurance exchanges verify the eligibility of all individuals applying for tax credits and cost sharing under the Affordable Care Act. Federal employees would be paid for furlough days resulting from the shutdown and members of Congress would be denied their cost-of-living increase in FY-2014.
The Senate passed the bill first with 81 senators voting in favor and 18 voting against the compromise. The House then passed the legislation 285-144, relying mostly on Democratic votes to pass the bill. Alongside the bill, the Senate agreed to a provision that House and Senate leaders would appoint a conference committee to negotiate a budget agreement by Dec. 13.