From: Enigl@aol.com
Date: Thu Oct 31 1996 - 18:06:42 MST
In a message dated 96-10-30 22:03:14 EST, Ian wrote:
<< Indeed it's true that the FDA and pharmaceutical
interests are seeking to restrict & ban vitamins. >>
I work with (but not for) the FDA. Both the FDA and pharmaceutical companies
are (so far) inhibited from bans and certain types of restrictions on
vitamins (nutritional supplements.) Why? Public pressure, political
correctness.
The last time FDA was "talking" about more restrictions i.e. vitamins as
having prescription drug status, they had their telephone lines clogged for
weeks with irate citizens. They backed down.
Even restrictions on the new "cosmeceuticals" (the crossover of cosmetics and
pharmaceuticals) was met with timidity by the FDA. I went to 1996 Annual
Scientific Seminar on Cosmeceutical Trends in LA . Dr. John Bailey, Branch
Chief Office of Cosmetics and Colors, FDA said no regulatory action will take
place at this time. They don't have a definition for this category (yet).
The FDA usually reviews complaints first. They have limited resources. If
they get complaints they will take action. Sometimes on individual companies
and sometimes on the whole industry.
The "safety first" type on complaint gets their attention this usually
involves adulteration and not complying with current good manufacturing
practices (cGMP). They want to make sure the consumer gets 3 mg (usually
within a tolerance of 95-105%) when the package says 3 mg. Also, the content
uniformity and dissolution of solid tablets is tested. There are many more
things they can test for, but usually don't depending on the complaint.
The FDA doesn't care to ban these products because of political pressure.
The pharmaceutical companies make money selling them but wished the
non-pharm. companies would "play fair" and comply with cGMPs (just as the
pharm. co. have to.) So, I think false complaints are "generated" to get
the FDA to investigate.
Efficacy takes a back seat to the above testing especially after the new
nutritional supplement and education act went into effect. The United States
Pharmacopeia (USP) 23 cGMP sections are where the drug and nutritional
supplement companies should look to keep FDA happy most of the time.
To me the FDA really doesn't care what is available to the public as long as
they retain political correctness. Remember when the law said all cosmetics
must be tested in animals? But the public balked at the idea of hurting
rabbits. The cosmetic companies I worked for said "We are going to
discontinue animal testing" and public pressure did not let the FDA enforce
the law (so far). BTW this does not mean the cosmetic companies do NO
testing. . . they now test in humans instead :-)
Dynamically Optimistic,
Davin
October 31, 1996
12:13 pm
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