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05/28/07 - Congressman Paul Reintroduces Health Freedom Protection Act H.R. 2117
Dr. Paul has reintroduced the Health Freedom Protection Act. Essentially this bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements.
It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered nonmisleading through the addition of a disclaimer." Thus, even "a scintilla" of scientific evidence would allow the making of claims that Dietary Supplements may be of benefit to individuals.
The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.''
The text of the bill, reintroduced on May 7, 2007, can be found at: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117
In my opinion, this bill would greatly enhance public access to truthful and not misleading health information, in keeping with the US Supreme Court's dictum in Thompson v. Western States Medical Centers, "If the First Amendment means anything, it means that regulating speech must be a last - not first - resort. *** We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. *** Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring ... a warning ..."
This bill, cosponsored by Congressmen Burton of Indiana, Shays, Bartlett of Maryland, and Duncan, presents a clear opportunity to enhance legal protections for Dietary Supplements and natural remedies. Its adoption would shift FDA resources from over-regulation of safe food substances to what could be considered their main task, protecting people from dangerous drugs and medical devices. Currently, we need to encourage other congresspeople to join as cosponsors and get behind the Health Freedom Protection Act.
The FDA "revitalization" bill was recently passed by the Senate; just before it was passed, when Congress noticed hundreds of thousands of people complaining to the FDA to leave our supplements alone, a protective clause was added, exempting Dietary Supplements. The House can now enhance that protection by extending it to all food substances and by adopting the Health Freedom Protection Act. Therefore, we should ask our congresspeople to attach the HFPA to the "revitalization" bill, HR 1561 (House equivalent of S. 1082). While we do not support the bill to increase FDA power, if it is passed, it should include protective language such as the HFPA language.
Support Dr. Paul's bill: http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11754
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05/06/07 - Good News this week! On 05/04 Congressman Ron Paul, physician and presidential candidate, termed the FDA anti-CAM draft guidance "an abuse of FDA power..."
On the same day, S.1082, a bill many viewed as a threat to health freedom was amended to exclude Dietary Supplements, so they would continue to be governed by existing law. As to why S.1082 was amended to protect Dietary Supplement Health and Education Act (DSHEA) products, I have it from people "on the Hill" that Congress knew a constituent storm was brewing.I am personally aware that key congresspeople knew about the huge public response to the FDA draft guidance ploys. When people started contacting congresspeople on the S.1082 issue, supporting Counsel J Emord's suggestion that S.1082 be amended, the Senate acted quickly and decisively. They knew what would happen if they did not act, since they had just seen the storm over the FDA guidance, where over 180,000 people told the FDA to leave our alternative health care practices alone. I think it is really naive to assume these events were not connected in Beltway mentality, as some commentators have suggested.Our view that the antiCAM guidance is dangerous is not some bizarre fringe view. For example, Congressman Ron Paul MD, America's only true Constitutionalist candidate for President (and the Robert Taft or Barry Goldwater of this generation) filed his objections to the antiCAMguidance. He called it "an abuse of FDA power." He concluded his detailed analysis of the failures of the guidance, and its dangers, with these stirring words:
"The CAM Guidance is imprudent and will stifle innovation in medicine. The CAM Guidance proceeds from a failure to appreciate the interrorem effect of government action. . . . There is no reason to believe that the states are ineffective in prosecuting those comparatively few practitioners, CAM or non-CAM, who do cause harm. Thus, without any true need for the guidance, it conveys to CAM practitioners that FDA regards certain therapeutic uses of products to be unlawful. As the agency should know that will, in turn, dissuade those uses, despite the dubious legal basis for FDA's assumption of power. By dissuading those uses, FDA deprives patients of health care options without any proof that its action will improve public health. That is an abuse of FDA power...In sum, I request the FDA to withdraw the CAM Guidance. If the rule is not withdrawn, I urge FDA to amend the rule to state unambiguously in the document that FDA is barred by the FDCA from regulating health care practice and that off-label use of any regulated product by a health carepractitioner is lawful under federal law."
When Natural Solutions Foundation said "We had a great victory!" we are referring to a victory by the broad Freedom Movement in this country, of which health freedom is just one aspect. No one organization has any monopoly over that movement and all deserve due credit for mobilizing the troops. We each have the right to our own opinions as to what correlation of forces led to such quick, and for us happy, congressional action. Our direct contacts on the Hill led us to our appraisal that the storm of protest over the FDA draft guidance last week emboldened our friends in Congress this week, and over-awed their opponents.
Vigilance must continue, but this does show that an aroused public can expect to be noticed by people in power in Washington.
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