White House's OMB Intervenes to Weaken FDA's Proposed Regulation of E-Cigs

On April 24, 2014, the U.S. Food and Drug Administration’s (FDA) issued a proposed regulation which would subject the currently unregulated e-cigarette industry to FDA regulation under the authority of the Federal Food, Drug and Cosmetic Act (FD&C Act). The proposed rule put e-cigarettes with a list of products FDA "deemed" tobacco products, and as such, subject to the FD&C Act. OMB intervened to weaken FDA's original proposal.

E-Cigs "Deemed" Tobacco Under New FDA Proposed Rule

 

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.

Join FDA in Miami to Discuss Major FSMA Proposed Rules

The U.S. Food and Drug Administration (FDA) announced it will hold two additional public meetings to discuss the Food Safety Modernization Act (FSMA) Proposed Rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies. 

The two proposed rules are designed to strengthen assurances that imported food meets the same safety standards as food produced domestically.  The FSVP proposal provides requirements for importers to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by the FSMA, and achieving the same level of food safety as domestic growers and processors. This will create a new burden for importers to know and trust their manufacturers.  I believe we can expect to see enforcement and penalties from FDA - if you have not met your manufacturer yet, now is the time!

The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies provides for the strengthening of quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains.

The purpose of the FDA’s public meetings is to solicit public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.

If you are interested in commenting on these proposed rules, contact me to discuss the process. Please note the timeline below to submit comments to the FDA. 

These two added meetings will take place in Miami, FL and Long Beach, CA.

Register here!

• Miami meeting - October 10-11, 2013, at the Hyatt Regency Miami, 400 SE Second Avenue, Miami, FL 33131.

October 10, 2013

8:30 a.m. – 5:00 p.m.

October 11, 2013

8:30 a.m. – 12:30 p.m.  

• Long Beach meeting - October 22-23, 2013, at the Hilton Long Beach & Executive Meeting Center, 701 West Ocean Boulevard, Long Beach, CA  90831

October 22, 2013

8:30 a.m. – 5:00 p.m.

October 23, 2013

8:30 a.m. – 12:30 p.m.

Please note the following important dates for the meetings in Miami, FL and Long Beach, CA:

• Meeting in Miami, FL
  
  
  
  • September 24, 2013: Closing date for request to make oral comment
  
  
  • September 24, 2013: Closing date to request special accommodation due to a disability
  
  
  • October 1, 2013: Closing date for advance registration

• Meeting in Long Beach, CA
  
  
  
  • October 1, 2013: Closing date for request to make oral comment
  
  
  • October 1, 2013: Closing date to request special accommodation due to a disability
  
  
  • October 8, 2013: Closing date for advance registration

• November 26, 2013: Closing date to submit either electronic or written comments to FDA’s Division of Dockets Management; for the proposed rule on Foreign Supplier Verification Programs, see Docket No. FDA-2011-N -0143. For the proposed rule on Accreditation of Third-Party Auditors/Certification Bodies, see Docket No. FDA-2011-N-0146.

If you manufacture or import food products you MUST stay on top of FSMA and the new rules FDA will implement.  For assistance in commenting on these important new changes, contact me.  See you at the Miami meeting.

OTI's - July 31 is Deadline to Voice Opinion on FMC's Proposed Changes

Now's the time to apply to become a non vessel operating common carrier (NVOCC) and/or ocean freight forwarder (OFF).  FMC has proposed major changes to its regulations and application requirements for Ocean Transportation Intermediaries (OTIs).   Get your application in now to avoid those changes, and/or, learn the changes and spend the time to comment on them while you can.  Detailed summaries of those changes are below.  July 31, 2013 is the cutoff to have your voice heard!

FMC issued an Advanced Notice of Proposed Rulemaking (ANPRM) that would significantly amend the regulations governing the licensing, bonding and duties of NVOCCs and ocean freight forwarders. The ANPRM is 117 pages long!! You can review the ANPRM in FMC’s Docket No. 13-05, Amendments to Regulations Governing Ocean Transportation Intermediary Licensing and Financial Responsibility Requirements, and General Duties. 

The major changes are:

• Qualifying Individual (QI) Changes – Included in the proposed changes are changes to many definitions - this one impacts what it will take to become a QI.  The standards will be tougher.  For one, the QI’s 3 years of relevant experience will only qualify if one has worked for a licensed, bonded, registered OTI. Experience obtained while the individual was employed by a licensed domestic OTI, a vessel operator, or a registered foreign-based NVOCC would be acceptable.
• All Owners will now be Vetted – Background checks will now not be limited to the QI, all owners will go through background checks (and my two cents, your application will take that much longer to be processed with every additional owner)..
• All Licenses will now be Online – FMC proposes to go green in its application process.  Application fees are much cheaper online, $250 vs. the paper application fee of $850.   
• License Renewal Every 2 Years! – All licenses, both forwarder and NVOCC, be renewed every two years, regardless of how long a company has held a license. As part of that renewal process, the licensee would be required to pay a filing fee in an amount yet to be determined. As proposed, the information to be provided would include the name of the current Qualifying Individual, all shareholders, officers and directors (and, their social security numbers), and require the production of corporate good standing certificates. Each company would be required to submit an application for renewal at least 60 days prior to the scheduled expiration dateof its current license. 
• Suspension/Revocation of Licenses – Under the current regulations, a license can be suspended or revoked for failing to respond to a lawful order, making materially false or misleading statements, or failing to have a current tariff or bond. The ANPRM now proposes to also subject licenses to revocation if the OTI “knowingly and willfully accepts cargo from, processes, books, or transports cargo” for, an NVOCC that is either unlicensed or fails to have the required bond. The Commission also proposes to“streamline” the appeals process for any revocation of licenses by eliminating an OTI’s right for a full evidentiary hearing. Indicating that such proceedings are “often lengthy and expensive,” the ANPRM proposes to establish a procedure by which appeals could be handled by a hearing officer on a written record, without any apparent right of discovery concerning matters that may be in the Commission’s files.
• Foreign Registered NVOCCs – The ANPRM would require foreign registered NVOCCs to submit a detailed registration form and a filing fee, with those registrations only valid for a period of two years. Under current regulations, and as is the case with existing OTI licenses, registrations are valid for an indefinite period. The foreign NVOs would be required, in their registration forms, to provide their legal name, any trade names, their principal business address with contact information, a contact person with an email address, and their U.S. resident legal agent.
• Increase Bond Requirements - Citing incidents in which two NVOCCs went out of business owing significantly more than the $75,000 bond, which meant that claimants were unable to recover all monies owed, the ANPRM proposes to increase all OTI bonds as follows: Ocean Forwarder $50,000 $75,000, Licensed NVOCC $75,000 $100,000, Registered NVOCC $150,000 $200,000, Group Bond $3 Million $4 Million
• Tiers for Claims on Bonds - The ANPRM would establish three tiers of payment priorities for claims against the bond.
• FMC Website Publication of Claims - The Commission would publish these notices and claims on its website, which would be available to the general public as well as the various sureties. 
• Prohibit Surety From Payment of 20%+ of Bond - Another proposal would prohibit the surety from paying any claims that amount to more than 20 percent of the face amount of the bond for a period of at least five months after the date the claim is received.
• License Revocation when Bond Termination Occurs – In this proposed rule, FMC licenses and registrations could be revoked “without hearing or other proceeding” in the event the required bond is terminated.
• New Class of NVOCCs for Household Goods – The commission seeks comments on such a change, not an actual proposal at this time.

How do you feel about these changes?  Think they are fair?  Want to comment to the FMC?  Make sure you speak up before July 31! Ready to submit your application? Contact me today at jdiaz@becker-poliakoff.com.