petitioning the FDA (YOU HAVE A LEGAL RIGHT TO DO THIS) so do it!
Posted by Petition Goddess on September 6, 2001 at 21:05:44:
In reply to: Petition specifics posted by Lauren on September 6, 2001 at 20:10:45:
Individuals can present petitions to the FDA. Here's their rant.These regs are written up for businesses submitting things to the FDA,
but as individual citizens we certainly are allowed to input our
(properly justified etc) petitions and letters.
Write it up nicely, and make it look good. The rant is there with the
medical backup, as well as a legal argument. This is actually not
more difficult than an exercise in high school civics class. You've
signed petitions to get things on a ballot, right? Ask your local
political party office if they have someone with experience in setting
up petitions. Political activists love to talk, and may be willing to
help!
If the FDA gets about 200 petitions a year, lets make damn sure henna
is one of them! Certainly, if they get packet after packet of the FDA
Henna Rant ... SOMEONE there will take notice, and might just re-word
that turkey statement without much fuss and bother.
######
As a regulatory agency, FDA publishes rules that establish or modify
the way it regulates foods, drugs, biologics,
cosmetics, radiation-emitting electronic products, and medical
devices--commodities close to the daily lives of all
Americans. FDA rules have considerable impact on the nation's health,
industries and economy. These rules are not
created arbitrarily or in a vacuum. They are formed with the public's
help.
By law, anyone can participate in the rule-making process by
commenting in writing on rules FDA proposes. FDA allows
plenty of time for public input and carefully considers these comments
when it draws up a final rule.
FDA gathers public comments mainly through two channels: proposed
rules and petitions.
Petitions
Another way to influence the way FDA does business is to petition the
agency to issue, change or cancel a regulation, or
to take other action. The agency receives about 200 petitions yearly.
Petitions require careful preparation by the submitter. FDA spends
considerable time and staff resources processing
petitions. Individuals sometimes submit petitions, but most come from
regulated industry or consumer groups. For
example, a drug company might request a change in labeling for one of
its products; a food company might ask that its
product be exempted from some provision of a regulation; or a consumer
group might petition FDA to tighten regulation of
a certain product.
Petitions submitted to FDA must contain:
Action requested--What rule, order, or other administrative action
does the petitioner want FDA to issue, amend or
revoke?
Statement of grounds--The factual and legal grounds for the
petition, including all supporting material, as well as
information known to the petitioner that may be unfavorable to the
petitioner's position.
Certification--A statement that to the best of the petitioner's
knowledge, the petition includes all information relevant to
the petition, favorable or not. The petition must be signed and
include the petitioner's address and phone number.
Petitions should be mailed or delivered to: Dockets Management Branch,
Food and Drug Administration, Room 1061,
5630 Fishers Lane, Rockville, MD 20852.
Ultimately, FDA management decides whether to grant a petition. But
first, agency staffers evaluate it, a process that may
take several weeks to more than a year, depending on the issue's
complexity. After FDA grants or denies the petition, the
agency will notify the petitioner directly. If not satisfied, the
petitioner can take the matter to court.
For more information on submitting petitions, consult Title 21 of the
Code of Federal Regulations, Sections 10.30, 10.33,
and 10.35.
Besides accepting public comments and petitions, FDA also schedules
public meetings and hearings to discuss and explain
its proposals. These usually are held with industry representatives or
consumer groups, but anyone interested may attend
and, with advance notice, may comment on a proposal. Meetings often
are held in the Washington, D.C., area, but
sometimes are set in other areas across the country. Meetings for the
public to present views are announced in the Federal
Register.
Copies of comments on FDA issues are available on the FDA Website.
Questions about the comment, petition or hearing process should go to
the FDA Dockets Management Branch, (301)
827-6860. Hours are 9 a.m. to 4 p.m., Eastern time, Monday through
Friday.
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