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Author Topic: WHY WE NEED H.R.3394 and H.R.3395  (Read 1254 times)

Offline RobertB

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WHY WE NEED H.R.3394 and H.R.3395
« on: September 20, 2009, 04:38:23 PM »
 WHY WE NEED H.R.3394 and H.R.3395

September 19, 2009
  The NHF has lobbied Congress for legislation to rein in the out-of-control Federal Trade Commission (FTC) and Food and Drug Administration (FDA) on dietary supplement health claims and advertising. Sponsored by Congressmen Ron Paul (R-TX) and Dan Burton (R-IN), H.R. 3394 and H.R. 3395 are the latest bills to end the use of "regulatory arbitrage" by both Agencies on these health freedom of choice public-policy issues.
   Regulatory arbitrage in this case means using arbitrary Federal agency authority to control freedom of speech, restrict access to supplements, and exercise control over manufacturers’ scientific evidence being offered in support of the health-benefit claims being made by that manufacturer. The FDA and the FTC have overlapping regulatory authority over the advertising of dietary supplements. The FTC is responsible for enforcing laws that prevent manufacturers from making misleading, false, or fraudulent claims about their products on product packaging or in advertising. The FDA is responsible for enforcing laws that prevent manufacturers from selling adulterated or misbranded products. The FDA’s definition of misbranded, i.e., a supplement product is a drug and not a supplement, is very loose and includes the manufacturer’s dissemination of truthful scientific evidence. There have been cases in which a structure-and-function claim used by a manufacturer, a health claim, has been interpreted differently by both the FDA and the FTC. The Agencies have differed even when the same statement is being used for advertising purposes. In all cases, the legal burden to prove that either Agency's interpretation/action is incorrect is placed upon the manufacturer.
  H.R.3394 would correct this "Catch-22" by placing the burden of proof in false-advertising cases involving dietary supplements and dietary ingredients on the FTC. A recent United States District Court case brought by the FTC against Lane Labs, and rejected by the Court, is but another example of FDA and FTC regulatory arbitrage.
  In the Lane Labs case, in 2000, the Company agreed to a consent decree with the FTC, after the FTC filed a suit against the Company. Lane agreed not to make any health statements about two of its products without the support of competent and reliable scientific evidence. In 2007, the FTC filed another suit, alleging that Lane Labs had violated the consent decree by making unsubstantiated claims for these supplement products. At the trial, Lane explained that it had met with researchers, conducted multiple studies when necessary to substantiate a claim, hired a compliance officer to insure that the company remained in compliance with the consent decree, and had submitted “multiple voluminous compliance reports” to the FTC.
  In rejecting the FTC motion to find the Company in contempt for allegedly violating the consent decree, the Federal court was particularly concerned that the FTC "had never reviewed these submissions, until after they brought this action." The court said that it would be “disingenuous” to punish the company after it had been making submissions to the FTC for years without any indication from the Agency that it was not in compliance with the consent decree. The Court also noted that there was no evidence that consumers were harmed by the Company’s supplements, and, therefore, the financial penalties being sought by the FTC for consumer injury would not be fair. A copy of the Court's ruling can be downloaded from the NHF website at
 This is but one small victory for the health-freedom community and a bigger victory for Lane Labs, supplement manufacturers, and consumers. The "regulatory arbitrage" and abuse of power by the FDA and FTC continues, and will continue, until legislation like H.R.3394 and H.R.3395 are enacted into law.
 Likewise, the NHF supports H.R.3395 to end the FDA abuse of power regarding supplement health claims. This bill would force the FDA to go to a Federal court and get a final court order that supported its position that a supplement health claim describing any nutrient in a food or dietary supplement (as defined in the DSHEA law) as mitigating, treating, or preventing a disease or disease symptom, or a health-related condition, makes the supplement product a drug. The FDA would have to show that there is clear and convincing evidence of consumer harm and that there is qualified expert opinion and published peer-reviewed scientific research that the claim being made is substantially false and misleading in any material respect. In other words, the whim of an FDA CFSAN bureaucrat, independently, or under the guise of helping a pharmaceutical company to restrict market competition would be subject to independent judicial review. The legal burden of proof would be placed on the FDA.
  The NHF strongly believes that these are two bills that the health-freedom community as a whole should support with grassroots letter-writing campaigns, and with Congressional lobbying efforts. Informing people about health-freedom legislative and regulatory threats is one thing; actively trying to influence decisions and outcomes is quite another. As the oldest and best-respected health-freedom group on Capitol Hill, the NHF continues to be the credible source of objective assessment of, and proactive actions on, Congressional legislation and FDA matters that have material impact upon our freedom-of-health choices and access to dietary supplements and nutritional foods.

For more information see:

H.R. 3394 Freedom of Health Speech Act   To amend the Federal Trade Commission Act concerning the burden of proof in false advertising in cases involving dietary supplements and dietary ingredients.
Bill text-
Sample Petition-

H.R. 3395 Health Freedom Act   To amend the Federal Food, Drug, and Cosmetic Act concerning claims about the effects of foods and dietary supplements on health-related conditions and disease, and for other purposes.
Bill text-
Sample Petition-

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 PRESS RELEASE by Lee Bechtel NHF National Lobbyist

National Health Federation: Established in 1955, the National Health Federation is a consumer-education, health-freedom organization working to protect individuals' rights to choose to consume healthy food, take supplements and use alternative therapies without unnecessary government restrictions. The NHF is the only such organization with recognized observer-delegate status at Codex meetings.

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« Last Edit: September 20, 2009, 05:29:05 PM by RobertB »