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A Quick Guide to the FDA’s Deeming Regulations for Vaping, Cigars, and All Other Tobacco Products

Recently, the Food and Drug Administration completed a ruling that expands their authority to all tobacco related products including e-cigarettes, cigars, pipes and hookah. These regulations were formulated to help improve the public’s overall health and well being as these products were already being sold but without any initial review regarding what they were made out of. Restricting sales to minors as well as controlling modifications and communicating health warnings are all part of these new rules.

Since the summer of 2009, the FDA has been allowed to regulate how tobacco products are manufactured and distributed. This new ruling was necessary because it took on e-cigarettes which are somewhat new to the market. Any of these products including accessories such as the best box mod options out there are all subject to approval and regulation. None of these items can be sold to a person under the age of 18 (photo identification must be provided during the purchase). Also, free samples cannot be handed out and none of these products can ever be provided through a vending machine.

The FDA believes that tobacco is harmful to the human body but they do acknowledge that newer products like e-cigarettes may be less harmful. They do still require monitoring and regulations though. Moving forward there will be an appeal process that will take place for electronic products and other tobacco products but the outcome is not known at this point. Hopefully, young adults will be prevented from starting the use of these products and the added control the FDA has will help keep people safer by educating them on the use of tobacco products. It is unlikely these products will ever be banned thanks to their current success as well as their higher safety standards than traditional cigarettes, cigars and pipes.

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EU holds firm on “open standard”, US firms go ballistic

The EU Commission announced on June 25 that EIF/2.0 (The European Interoperability Framework which defines the rules for software used in e-Government) will hold the line as regards patents on standards.

The announcement is expected to annoy those who wanted a “broad” definition of open standards that would include patented standards. As expected, the Business Software Alliance and the Association for Competitive Technology, both vocal in their defense of software patents and patented standards, have denounced the move as “imposing one business model over another”.

The move has also been described as “hurting small tech start-ups that rely on patent protection to survive”. “Even programs like BlueTooth are excluded”, says ManagingIP.

The BSA and ACT are notorious spokesmen for large US corporate interests, and claims that small, innovative European technology firms need patents to survive do not match the data. A recent EU-sponsored study on the use of patents, copyrights, and trademarks in European software SMEs had to go to Israel to find SMEs that held and licensed software patents. Apparently European IT SMEs just don’t use patents.

The Commission’s robust defense of the term “open standard” and its support for open source software reflect the reality of the European technology sector, which is overwhelmingly made up of SMEs that use, produce, and depend on an increasingly sophisticated ecology of open source and open standards.

The principle that e-Government should not be captured by vendors is a good one, though it goes against the corporatist trends we see in many parts of the world, and infuriates large US technology interests, who covet the growing EU government budgets. The deregulation and outsourcing of the state, by and for private interests, has become so accepted in the US that one can understand the shock and horror with which US corporate interests view the EU’s insistence on large government and regulation. The term “free market” has almost opposite meanings on the two sides of the Atlantic.

We therefore expect to see concerted lobbying against the EIF/2.0 definition by the patent industry, by Microsoft, BSA, ACT, and the many dependent organizations that represent Microsoft business partners (ironically called “the European software industry” by some). Specifically, we expect to see accusations that the no-patents definition of open standards discriminates against specific providers, that it damages innovation, that it ignores the value of patents, that it will result in innovative firms leaving Europe, that it is illegal under trade agreements, and so on. We expect to see pressure applied on the Commission from the highest levels of US power.

Digistan applauds the EU Commission, and holds that patents have no place in open standards except as a mechanism to exclude competition and to raise costs to the State and EU citizens. Furthermore, EIF/2.0 does not exclude patented standards from e-Government, it simply does not allow these to claim the label “open”.

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Definition of a Free and Open Standard

The Digital Standards Organization defines free and open standard as follows:

  • A free and open standard is immune to vendor capture at all stages in its life-cycle. Immunity from vendor capture makes it possible to freely use, improve upon, trust, and extend a standard over time.
  • The standard is adopted and will be maintained by a not-for-profit organization, and its ongoing development occurs on the basis of an open decision-making procedure available to all interested parties.
  • The standard has been published and the standard specification document is available freely. It must be permissible to all to copy, distribute, and use it freely.
  • The patents possibly present on (parts of) the standard are made irrevocably available on a royalty-free basis.
  • There are no constraints on the re-use of the standard.

The economic outcome of a free and open standard, which can be measured, is that it enables perfect competition between suppliers of products based on the standard.

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The Hague Declaration

Adopted and proclaimed
by the founders of the Digital Standards Organization
in The Hague on 21 May 2008.

Whereas almost 60 years ago the Universal Declaration of Human Rights, established in international law these rights and freedoms:

  1. Freedom from discrimination by government or law (Article 2, Article 7).
  2. Freedom of movement within the borders of each state (Article 13.1).
  3. The right to participate in government (Article 21.1).
  4. The right of equal access to public services (Article 21.2).

Whereas these rights and freedoms are today accepted by every democratic government and backed by the constitutions of most states;

Considering that all countries are moving, at different rates and from different starting points, towards a society in which full and effective participation in government and society, and access to public services, education and opportunity, are increasingly dependent upon access to electronic communications;

Considering more specifically that:

  • Government information, services and resources are increasingly provided virtually rather than physically;
  • Freedom of speech and association are increasingly exercised on line rather than in person;
  • The Internet and the Web provide an unprecedented avenue to equality of education and opportunity for all peoples throughout the world;

Considering that the benefits of the Internet may only be guaranteed, and our hard-won human rights may only be preserved as we make the transition to a digital society, by ensuring affordable, equal access to the Internet, and if the openness of the Internet is also preserved;

Considering the unique role that free and open digital standards can play in ensuring this result by fostering competition and innovation, lowering costs and increasing choice;

Considering that governments, through example and procurement, are uniquely able to ensure that all people achieve the benefits that free and open digital standards can provide;

Considering that these benefits are of particular importance to the economically, socially, and geographically disadvantaged peoples of the world;

Considering that there is increasing consensus on the attributes of a free and open digital standard;

We call on all governments to:

  1. Procure only information technology that implements free and open standards;
  2. Deliver e-government services based exclusively on free and open standards;
  3. Use only free and open digital standards in their own activities.

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