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  • Main Subject - Unsolicited Commercial Email, SPAM and the FTC

    Most recently the Federal Trade Commission has put forth their requests for further budget funding for fiscal year 2007 and in this report to Congress for more tax
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    payer’s monies the FTC cited their efforts to curb SPAM. Yet many critics of the agency who have called it everything from incompetent to the Blob of Bureaucracy b
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    elieve that the FTC has done little since the CAN SPAM Act to enforce this unsolicited commercial email. Here is what the FTC told the US Congress:

    SPAM.

    “Expert
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    have estimated that spam (unsolicited commercial email) costs businesses between $10 billion and $87 billion annually. Additionally, consumers spend countless hou
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    rs each year dealing with spam. The CAN SPAM Act provides the FTC with tools to address this issue.”

    Perhaps they have the tools to address the issue, yet SPAM ha
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    increased not decreased under their watch. Additionally the FTC cites another piece of information:

    “In April 2005, the FTC and the California Attorney General b
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    rought an action to halt an operation that sent millions of illegal spam messages touting mortgage loans and other products and services. The FTC's Adult Labeling
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    Rule and the CAN.SPAM Act require commercial e-mailers of sexually-explicit material to use the phrase SEXUALLY EXPLICIT:" in the subject line of the e-mail messag
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    and to ensure that the initial viewable area of the message does not contain graphic sexual images.”

    If in fact the State of California can take care of this, wh
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    y are we doubling up and paying the FTC to work on it too? This duplication has to be costing the US Taxpayers millions of dollars, is it not? Meanwhile the FTC’s
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    eport goes on to state:

    “In 2005, the FTC filed suit against a network of individuals and corporations that used spam to sell access to online pornography, and ch
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    arged seven companies with violating the labeling requirements of the Rule and the Act. The spammers paid $691 000 to settle the charges and agreed to injunctive r
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    elief.”

    But one case is not sufficient at all. There are thousands of spammers out there and this one case is not even a drop in the bucket, surely the agency wit
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    all this power and weight and self-aggrandizement can do better than this? Yet the FTC always falls back to the more safe position when asking for money from Cong
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ress and stated:

    “The FTC also continued to work on the rulemaking and reporting requirements mandated by the CAN-SPAM Act. In June 2005, the FTC issued a report
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    o Congress on the use of subject line labeling for commercial email as a means to reduce spam, concluding that such labeling would not be an effective way to curb
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    spam. December 2005, the FTC issued a report to Congress on the effectiveness and enforcement of the CAN.SPAM Act. That report concluded that, while the Act has he
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    lped to deliver some improvements, passage of the U.S. SAFE WEB Act, continued education efforts, and improvements in anti-spam technology also are needed.”

    And t
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    ere you have it folks rather than telling the US Congress that the FTC is incompetent they tell them they need more of our money to finish a job that they are fail
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ing at. Meanwhile we have Yahoo and AOL planning their own way to make money sending us SPAM and the FTC is going to do nothing about it. Consider the this in 2006


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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