This product is said by it's makers to be Homeopathic.  If you go here-http://www.homoeopathic.com/- you will find essentially, a welcome to nothing!  Which made me laugh for I figured I could get the info. I wanted to confirm from the horses mouth that Homeopathic means the product has essentially nothing but trace amounts or less of any drug, herb, etc. in it- and as such doesn't need any approval.  Some kind well intentioned soul with humor apparently commandered that site.  There is some regulation of Homeopathic remedies.  See...http://www.fda.gov/fdac/features/096_home.html
  We find therein..."With the minimum dose, or law of infinitesimals, Hahnemann believed that a substance's strength and effectiveness increased the more it was diluted. Minuscule doses were prepared by repeatedly diluting the active ingredient by factors of 10. A "6X" preparation (the X is the Roman numeral for 10) is a 1-to-10 dilution repeated six times, leaving the active ingredient as one part per million. Essential to the process of increasing potency while decreasing the actual amount of the active ingredient is vigorous shaking after each dilution.
  Some homeopathic remedies are so dilute, no molecules of the healing substance remain. Even with sophisticated technology now available, analytical chemists may find it difficult or impossible to identify any active ingredient. But the homeopathic belief is that the substance has left its imprint or a spirit-like essence that stimulates the body to heal itself."  and..."FDA regulates homeopathic drugs in several significantly different ways from other drugs. Manufacturers of homeopathic drugs are deferred from submitting new drug applications to FDA. Their products are exempt from good manufacturing practice requirements related to expiration dating and from finished product testing for identity and strength."  and...""The reasoning behind [the difference] is that homeopathic products contain little or no active ingredients," explains Edward Miracco, a consumer safety officer with FDA's Center for Drug Evaluation and Research. "From a toxicity, poison-control standpoint, [the active ingredient and strength] was deemed to be unnecessary.""  and..."Overall, the disparate treatment has been primarily based on the uniqueness of homeopathic products, the lack of any real concern over their safety because they have little or no pharmacologically active ingredients, and because of agency resources and priorities," explains Miracco.
  However, homeopathic products are not exempt from all FDA regulations. If a homeopathic drug claims to treat a serious disease such as cancer it can be sold by prescription only. Only products sold for so-called self-limiting conditions--colds, headaches, and other minor health problems that eventually go away on their own--can be sold without a prescription (over-the-counter)."  and..."FDA is aware of a few reports of illness associated with the use of homeopathic products. However, agency review of those reported to FDA discounted the homeopathic product involved as the cause of the adverse reaction. In one instance, arsenic, which is a recognized homeopathic ingredient, was implicated. But, as would be expected, FDA analysis revealed the concentration of arsenic was so minute there wasn't enough to cause concern, explains Miracco. "It's been diluted out.""  and...
  "Real Medicine or Wishful Thinking? 
  Many who don't believe in homeopathy's effectiveness say any successful treatments are due to the placebo effect, or, in other words, positive thinking.
  But homeopathy's supporters counter that their medicine works in groups like infants and even animals that can't be influenced by a pep talk. Jacobs adds that sometimes she mistakenly gives a patient the wrong remedy and he or she doesn't get better. "Then I give the right remedy, and the person does get better," she says. "So it's not like everybody gets better because it's all in their head. I think it's only because we don't understand the mechanism of action of homeopathy that so many people have trouble accepting it."  
  The American Medical Association does not accept homeopathy, but it doesn't reject it either. "The AMA encourages doctors to become aware of alternative therapies and use them when and where appropriate," says AMA spokesman Jim Fox.""
  And I say the average Dr. would tell you that that there simply isn't enough of anything in Homeopathic remedies to actually have any effect one way or another.  Someone here mentioned Vaseline in the nose as protection against colds...well it wouldn't surprise me if that's just as good and a lot cheaper than this product- if messier.  Now THERE is a study worth doing.  
  Dan B
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