Sunday, September 23, 2007

Amending HR2117 to further protect health freedom

The following is text from a memo I helped to provide to Natural Solutions Foundations about suggesting language to Congress to further protect Health Freedom.

"This memorandum is provided for the Natural Solutions Foundation – – to support our efforts to educate Congress and decision makers on the public’s concern for real reform of FDA’s food safety and claims authority. Several bills are pending in Congress that address some of these concerns. Dr. Ron Paul of Texas has offered HR 2117, the Health Freedom Protection Act. Your legal advisory group recommends this bill as consistent with the Natural Solutions program.

The bill, introduced earlier this year, mandates FDA “shall allow with reasonable and concise disclaimers not to exceed three sentences claims…” including “…the cure, mitigation, treatment, or prevention of any disease or any health-related condition.” It also addresses several other technical issues.

In our 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.

Since the bill was introduced, however, the FDA has continued its blitz of confusing food regulatory initiatives. After years of “benign neglect” several initiatives, such as the CAM Guidance, Health Claims Guidance, Good Manufacturing Practices and AER Regulations – all hitting the dietary supplement and natural products markets this year – threaten to stop and reverse progress toward meeting public demand for access to nutritional supplements, natural remedies and clean, unadulterated food.

We therefore recommend that pro-health Senators take up the issue of these recent threats to the intent of DSHEA when considering legislation similar to Dr. Paul’s House bill, by including the following items in addition to the important points addressed by HR 2117. Attached to this memorandum is a listing of the recommended amendments to HR 2117. A marked-up copy of the bill is also available."

The recommended amendments attached to the memo include the following "findings" by Congress:

"1. Congress determined United States policy regarding Dietary Supplements with the unanimous adoption of the Dietary Supplement Health and Education Act of 1994 (DSHEA);

2. That policy is: Dietary Supplements, including those offered to benefit health, are foods and foods are generally considered safe; United States law and regulations regarding Dietary Supplements shall be harmonized with food law in recognition of the remarkable safety record of Dietary Supplements, and

3. United States and international agencies have failed to implement or significantly acknowledge this policy,

The Congress of the United States determines that further protections are needed to restore the People’s right to freedom of choice in health care and dietary supplementation use. Further, food safety and claims regulation is too important a matter to remain a secondary mission for the Food and Drug Administration and, it is the sense of Congress, that this vital mission be divested from FDA and administered separately."

The amendments protect our First Amendment Rights by mandating that FDA "...shall not issue any regulation to limit the publication or dissemination of information published by a third party source characterizing the relationship of any nutrient to the prevention, mitigation, treatment or cure of any disease or health condition. "

There are also two new sections suggested for the bill:

SEC. 6. HARMONIZATION WITH FOOD REGULATIONS. - which begins the process of protecting foods (including supplements) from being treated as "drugs."

SEC. 7. COMMISSION TO STUDY DIVESTITURE OF THE FOOD AND DRUG ADMINISTRATION FOOD SAFETY AND CLAIMS AUTHORITY. - which begins the process of focusing FDA on its core mission of protecting the public from dangerous drugs and medical devices, by shifting foods safety and claim authority from the agency. Studying these issues might be a good first step. There are a number of different views being expressed. Some suggest a new Food Safety Agency is needed; others think the USDA can deal with food safety, as that is already part of its mission, while FTC can handle consumer complaints about claims, as this is already its mission. I prefer free market approaches to all safety and claims issues, with strict liability for marketers who harm their customers.

# # #

No comments: