AAPS Supports Health Freedom Acts

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This week AAPS wrote to members of Congress to ask them to support H.R. 3394 and H.R. 3395.  These bills known respectively as the “Freedom of Health Speech Act” and the “Health Freedom Act” seek to limit the Federal Government from over-regulating dietary supplements. 

For more information on these two bills read the two letters from AAPS copied below and click here to listen to Jim Turner explain to AAPS’ Michael Ostrolenk why the government’s powers to regulate dietary supplements should not be expanded.

Also, please contact your member of Congress to ask them to support H.R. 3394 and 3395.  You can find your representative’s contact information at http://www.house.gov/house/MemberWWW_by_State.shtml.

AAPS Supports H.R. 3394  “Freedom of Health Speech Act”

Dear Representative:

The Association of American Physicians and Surgeons, a national, non-partisan professional association of physicians in all specialties founded in 1943, supports H.R. 3394  “Freedom of Health Speech Act”

H.R. 3394 prohibits the Federal Trade Commission (FTC) from investigating and acting against an entity for communicating the health benefits of its products unless the FTC presents clear and convincing evidence that an advertisement for a dietary supplement or dietary ingredient is false and that, but for the false advertising content, the consumer would not have made the purchase at the price paid.  Additionally, it requires the FTC, if a claimed health benefit is alleged to be false advertising, to additionally establish, based on expert scientific opinion and published peer-reviewed scientific evidence, that the claim is false.

We strongly encourage you to vote for health freedom and informed consumers and co-sponsor H.R. 3394 “Freedom of Health Speech Act”

Sincerely,

Jane M. Orient, M.D. Executive Director

AAPS supports Health Freedom Act – H.R. 3395

Dear Representative,

The Association of American Physicians and Surgeons, a national, non-partisan professional association of physicians in all specialties founded in 1943, supports H.R. 3395  “The Health Freedom Act”.

Health Freedom Act – Prohibits the federal government from preventing the use of a claim describing any nutrient in a food or dietary supplement as mitigating, treating, or preventing any disease, disease symptom, or health-related condition, unless in a final order following a trial on the merits a federal court finds clear and convincing evidence based on qualified expert opinion and published peer-reviewed scientific research that: (1) the claim is false and misleading in any material respect; and (2) there is no less speech restrictive alternative to claim suppression that can render the claim non-misleading.

Amends the Federal Food, Drug, and Cosmetic Act to deem a food or dietary supplement for which a claim characterizing the relationship of a nutrient to a disease or health-related condition not to be included in the definition of “drug” solely because of such claim.

Revises dietary supplement labeling exemptions to prohibit the government from preventing distribution of a publication concerning the sale of a food or dietary supplement unless: (1) it establishes that a claim contained in the publication names the specific food or supplement sold and represents that the food or supplement mitigates, treats, or prevents a disease; and (2) the claim is proven to be false and misleading in any material respect by final order of a federal court in accordance with this Act.

We strongly encourage you to vote for health freedom and informed consumers and co-sponsor H.R. 3395 “The Health Freedom Act.”

Sincerely, 

Jane M. Orient, M.D., Executive Director

2 Comments

  1. This whole area is a very “sticky wicket.” Some very nasty stuff has appeared in this largely unregulated arena. Examples: “Chinese herbs” that contain dexamethasone, glyburide or chloramphenicol. Hepatotoxic “herbal” that contain a wrong ingredient – something other than what is on the label, included via misidentification or deliberate fraud by the supplier.

    Our FDA has no budget for researching this field or testing any supplement. They can only act if they have strong reason to believe that a product is dangerous, and they can’t know that until someone has died or been seriously harmed by a “supplement.”

    As it stands, we have only the desire of the supplement manufacturers to maintain their good names to motivate them to follow good manufacturing practices. The public is largely unaware that the FDA does not inspect these plants or have any role in assuring the potency, safety or effectiveness of supplement. I have patients every month who ask about a new “supplement.” When I tell them there is no peer-reviewed research published on the item and that the FDA does has not had any role in approving its distribution to the public, they are shocked. They mistake the testimonial in the newpaper advert for valid research.

    ON THE OTHER HAND, there are at least three supplement available over-the-counter that are not only safe, but essential for good health and/or adequate treatment of certain conditions.

    Every patient with diabetes must be taking alpha lipoic acid. It has been shown to lessen the progression of neuropathy, nephropathy and retinopathy. It is also the only effective treatment for the burning mouth syndrome (look it up on Pub Med). In animal models of multiple sclerosis it prevents the neurologically damaging CNS changes. By lowering oxidative stress, it also prevents the progression of pre-diabetes.

    Vitamin D prevents diabetes (in the adult and in the children of vitamin D replete pregnant women). It also prevents coronary disease and myocardial infarction. It is necessary for the proper immune response to a granulomatous infection. It may prove to be our only effective response to multiply-drug-resistant tuberculosis. In NHANES III, only persons in the lowest quartile of 25-hydroxyvitamin D levels showed any effect of calcium intake on bone density. Thus, our emphasis on increasing calcium intake (which can increase the risk of nephrolithiasis and coronary disease) may need to be replaced by advice to increase vitamin D intake and maintain a moderate calcium intake.

    Co-enzyme Q10 must be taken by any statin-treated patient, since the statin lowers CoQ10 levels. in rare subjects the CoQ10 level may go low enough that irreversible damage to mitochondrial DNA occurs, leading to a severe and permanant neuropathy. Supplementation in animal models can prevent this type of damage. In humans, CoQ10 supplements have been shown to restore the circulating level of CoQ10, reduce the degree of oxidation of lipoproteins (thus reducing their ability to enter macrophages and contribute to plaque formation), and to improve the ejection fraction (or cardio-thoracic ratio in an older study) of statin-treated patients with reduced EF.

    Any action by Congress that reduces the availability of these three supplements or increases their cost will do great harm to the US public and to our health.

  2. Continuing the above

    The solution?

    Don’t outlaw supplement in blanket fashion or require the companies to do prohibitively expensive pre-market testing.

    Instead, increase NIH’s funding for “alternative health” research, including major funding for proper clinical studies.

    Make it easier for physicians to report suspected ill effects of supplements (have you ever tried to submit an FDA form on an adverse event???)

    Increase the FDA’s budget for surveillance. Allow valid health claims for supplements, but only when peer-reviewed studies support it (see above). Meanwhile, strengthen oversight of advertisements (print and airways) to discourage unsupported health claims (and increased fines when this regulation is violated – “Product X increases your testosterone levels!”)

    Perhaps require supplement manufacturers to submit to the FDA a simple two line form that states that their factory does follow US Pharmacopeia good manufacturing practices (less strict that the FDA’s rules for drug-manufacturing plants) and that their product does not contain any FDA regulated medications (like dexamethasone or glyburide). This form could then be used as prima facia evidence to support prosecution for fraud when a company is found to have strayed from these standards.

    The FDA will need additional funding for random analysis of samples from the field (obtained in the same way Consumers Reports get their products for testing) and for plant inspections (to a different standard).

    I predict that Congress will not increase funding for the FDA or for proper research into herbal and supplement health matters. We’ll see.

    Just my thoughts….