I have annotated this
dangerous piece of legislation in red.
Blue
is used for emphasis and to coordinate
my commentary with the
text of the Bill itself.
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1ST SESSION H. R. 3156 To amend the Federal Food, Drug, and Cosmetic Act with respect to dietary supplements. IN THE HOUSE OF REPRESENTATIVES
Mrs. DAVIS of California (for herself, Mr. WAXMAN, and Mr. DINGELL) introduced the following bill; which was referred to the Committee on Energy and Commerce
A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to dietary supplements. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled SECTION 1. SHORT TITLE. This Act may be cited as the "Dietary Supplement Access and Awareness Act". It may also be cited as the "Diabolical Scheme Angering All Americans". SEC. 2. DIETARY SUPPLEMENTS; PRODUCT LISTING; REPORTING, POSTMARKET SURVEILLANCE, AND OTHER PROVISIONS REGARDING SAFETY. (a) IN GENERAL.—Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341SEC. 416. DIETARY SUPPLEMENTS; PRODUCT LISTING; REPORTING, POSTMARKET SURVEILLANCE, AND OTHER PROVISIONS REGARDING SAFETY. (a) LIMITATION ON APPLICABILITY.—Notwithstanding the other subsections of this section, this section does not apply to any dietary supplement that meets the conditions described in paragraphs (1) and (2), as follows:No definition is given of what constitutes a dietary supplement. So let's try and put one together: diet
n. - food or drink regularly consumed
So for example wine is a drink regularly consumed by some people (i.e. is a part of their diet). It contains alcohol. Beer provides additional alcohol, and can be used to complete (in other words supplement) the amount of alcohol a person regards as needful for his well-being. So beer perfectly qualifies as a dietary supplement. Beer does not contain any of the above dietary ingredients.(1) The supplement bears or contains one or more of the following dietary ingredients: Beer does contain an herb.(2) The supplement does not bear or contain— herb n. - a plant lacking a permanent woody stem, valued for its medicinal, savory or aromatic qualities Beer contains hops. Hops are a well-documented sedative. Tea or an herbal smoke made from this herb is beneficial for mood swings, stress and anxiety. Hence beer qualifies in every respect as the kind of a dietary supplement to which this Bill applies. In particular, this requirement, to report all serious adverse experiences by customers consuming their product, shall apply to all breweries. The breweries will be kept real busy investigating reports from hundreds of thousands of people experiencing the many well-known serious adverse experiences which result from the use of alcohol.(2) INVESTIGATION AND FOLLOW-UP.—A person submitting a report under paragraph (1) on a serious adverse experience shall promptly investigate the experience, and if additional information is obtained, shall report the information to the Secretary not later than 15 days after obtaining the information. If no additional information is obtained, records of the steps taken to seek additional information shall be maintained by the person. It will be interesting to see whether the Secretary will determine that the public's health does not need to be protected from alcoholic beverages. If DSHEA is not effective in protecting herbal supplements from the withering reach of this legislation, then why should the 19th Amendment, repealing prohibition, stand in the way of regulating alcohol into oblivion.(3) AUTHORITY OF SECRETARY.—In addition to requirements established in this subsection, the Secretary may establish such requirements regarding the reporting of information on adverse experiences as the Secretary determines to be appropriate to protect the public health. The Secretary may establish waivers from requirements under this subsection regarding such information if the Secretary determines that compliance with the requirement involved is not necessary to protect the public health regarding such supplements. In particular, the supplement manufacturer may have become aware that it was a disgruntled ex-employee, or an associate of the same, who reported an adverse event to their doctor, and tried to implicate a particular supplement made by this ex-employer in an obvious effort to seek revenge. So by this provision the manufacturer is forced to ASSIST such an ex-employee in that employee's nefarious scheme to injure said manufacturer!(4) DEFINITIONS.—For purposes of this subsection:(A) The term ‘adverse experience regarding a dietary supplement’ means any adverse event associated with the use of such supplement in humans, whether or not such event is considered to be related to the supplement by a person referred to in paragraph (1) who obtains the information. death - use of the dietary supplement known as beer may be shown to have bben a causal contributor to death when ingested in large quantities, and/or in conjunction with immersion in hot water, and/or in conjunction with operating a motor vehicle, and/or when taken while in a physically "compromised" condition, etc.(B) The term ‘serious’, with respect to an adverse experience regarding a dietary supplement, means an adverse experience that— birth defect - use of the dietary supplement known as beer may be shown to have been a causal contributor to a birth defect when ingested by the mother in any quantity during pregnancy. Brewers may be ordered by the Secretary to conduct postmarket surveillance, i.e. monitor the usage of their beers by customers, if there is a reasonable possibility that a use, including the reasonable expected use scenario of overindulgence in alcohol, may have serious adverse health consequences.(d) POSTMARKET SURVEILLANCE.—The Secretary may by order require a manufacturer of a dietary supplement to conduct postmarket surveillance for the supplement if the Secretary determines that there is a reasonable possibility that a use or expected use of the supplement may have serious adverse health consequences.(ii) requires medical or surgical intervention to prevent one of the outcomes described in clause (i). (e) AUTHORITY TO ORDER DEMONSTRATION OF SAFETY.—This section is completely unrelated to the entire rest of the Bill. It does not address the IMAGINARY public safety hazards posed by the natural herbal ingredients found in dietary supplements, like the rest of this Bill does. Rather it concerns the REAL public safety hazards posed by ADULTERATION, i.e. the existence of toxic CONTAMINANTS which may have found their way into a batch of such supplements. As such it is the only section of this Bill that has any claim whatsoever to legitimacy. This section is really underhanded. By singling out special treatment for supplements, based on the AGE of those who use them, it seeks to establish, in direct contradiction to DSHEA, that they are not to be treated as foods, but are rather in the same class as controlled substances such as tobacco.(1) IN GENERAL.—If the Secretary has reasonable grounds for believing that a dietary supplement may be adulterated under section 402(f)(1), the Secretary may by order require the manufacturer to demonstrate to the Secretary that the supplement is not so adulterated.(f) SALES TO MINORS; SIGNIFICANT RISK.— And why is there no requirement that BENEFITS be determined by the appropriate science-based evidence, as there is the requirementin, the following paragraph, that RISK assessment be science-based ? Is it because, as in the case of the Codex Alimentarius Commission, the sponsors and backers of this bill are afraid of the sciences of nutrition and bio-chemistry, and only want to allow use of the junk science of "toxicology"?(1) CRITERIA.—Not later than the expiration of the two-year period beginning on the date of the enactment of the Dietary Supplement Access and Awareness Act, the Secretary shall by regulation establish criteria for making a determination that a dietary supplement may pose a significant risk to individuals who are under the age of 18 (referred to in this section individually as a ‘minor’).(g) RECORDKEEPING ON SAFETY ISSUES.— It just gets more and more removed from sound science, and common sense. A dietary supplement can be assessed as being risky, merely because the chemical formula of an ingredient is SIMILAR to some artificial drug molecule! Is water (H2O) therefore to be considered a danger to public health because its chemical formula is related to hydrogen peroxide (H2O2) which it would not be advisable to drink?(B) A determination by the Secretary under clause (A) with respect to the risk of a product may be made on the basis of any science-basedevidence of risk, without the need to prove that the substance has actually caused harm in particular cases. The Secretary shall consider any relevant evidence including but not limited to scientific data about the toxicological properties of a dietary ingredient or its mechanism of action; known effects of pharmacologicallyrelatedcompounds, including those regulated as drugs; the results of clinical studies, including observational studies; and adverse event reports. And why is there no requirement to use scientific procedure in an effort to IDENTIFY and SPECIFY the levels of a dietary ingredient at which a supposed risk exists? Obviously there are ridiculously high amounts of ANYTHING, including food and water, that the body would not be able to successfully process. So this section is saying that as long as there is the SLIGHTEST uncertainty as to where that upper level of ridiculousness exists, any supplement containing even the most miniscule trace amounts of a substance under "suspicion" must be deemed as presenting and unreasonable risk.(C) A determination that a product presents an unreasonable riskmay be made under clause (A) by the Secretary even though there are uncertainties as to thelevels of a dietary ingredientthat may present a risk.’’. Well, what is unreasonable is this whole CODEX-like concept and approach. Due to the variations in individual human beings, it will ALWAYS be impossible to specify ABSOLUTELY CERTAIN, GENERALLY APPLICABLE LEVELS of amount and concentration for ANYTHING. I assume the (c) here should really be (i). But don't even try to understand this whole section. It illustrates exactly two things about legalistic obfuscation, which is done deliberately(c) INSPECTION AUTHORITY.—Section 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended—(3) TRADE SECRETS.—Section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)) is amended by inserting 416,’’ after 414,’’. 1. to ensure unlimited employment for the lawyer
class to which the majority of legislators belong; and
The net result of this ever growing bureaucratic mountain of regulatory legislation is to increase dramatically the cost to consumers of the products affected. This is because the manufacturer has to pass along his increased costs from: 1. any fees incident to complying with the
regulations;
to name just a few. And all this is on top of the direct cost to the consumer of higher taxes to pay the salaries and other expenses entailed in maintaining and operating yet one more huge federal bureaucratic boondoggle. (1) in paragraph (1), by inserting after the second sentence the following: In the case of any person who manufactures, processes, packs, transports, distributes, holds, or imports a dietary supplement with respect to which an order under section 416(e)(1) has been issued, the inspection shall extend to all records, files, papers, processes, controls, and facilities bearing on whether the dietary supplement is adulterated under section 402(f)(1).’’; and (2) in paragraph (2), in the matter preceding subparagraph (A), by striking third sentence’’ and inserting fourth sentence’’.SEC. 3. EDUCATION PROGRAMS REGARDING DIETARY SUPPLEMENTS. (a) HEALTH CARE PROFESSIONALS.—In particular, doctors shall be educated to report to the FDA adverse health experiences that are associated with the dietary supplement beer.(1) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the Secretary’’), acting through the Commissioner of Food and Drugs, shall carry out a program to educate health professionals on the importance of reporting to the Food and Drug Administration adverse health experiences that are associated with dietary supplements. In particular, consumers of alcohol shall be educated to inform their doctors of the beers they have been drinking, so that reports can be made to the FDA, with the result that the brewing and marketing of beer shall be prohibited in the United States of America. For just as this bill envisions being able to ban EVERY BRAND of a particular herbal supplement as long as ONE BRAND is deemed to present a risk, so EVERY BRAND of beer will be banned once a SINGLE BRAND is deemed to preset a risk.(2) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out paragraph (1), there is authorized to be appropriated $5,000,000 for fiscal year 2006, in addition to any other authorization of appropriations that is available with respect to such purpose.(b) CONSUMERS.—(1) IN GENERAL.—The Secretary, acting through the Commissioner of Food and Drugs, shall carry out a program to educate consumers of dietary supplements on the importance of informing their health professionals of the dietary supplements and drugs the consumers are taking. So ten million dollars every year, or exactly ONE BILLION DOLLARS down the drain every century - assuming there will never be any funding increases over the next hundred years :) Is anyone still confused as to why the Federal government of the United States is on the verge of bankruptcy?(2) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out paragraph (1), there is authorized to be appropriated $5,000,000 for fiscal year 2006, in addition to any other authorization of appropriations that is available with respect to such purpose. |
| PostScript:
Of course Congress would never want to ban such a harmless substance as ALCOHOL, nor for that matter the eminently safe product TOBACCO - either outright by forbidding their manufacture, or equally as effectively by imposing regulatory costs that would put manufacturers out of business and/or drive the prices up to the point where consumers would be unable to afford them (e.g. beer at $75 for a six-pack, or cigarettes at $5 dollars apiece). Instead, our legislators will zero in on NATURAL HERBAL REMEDIES, many in use for hundreds, and in some cases thousands of years without a single "adverse event" they can point to, thus driving the price of Echinacea up from $14 to $153 a bottle, as has already happened in CODEXed Norway. Seriously, why do you suppose they would leave the liquor and tobacco industries alone, given the enormous amount of sickness and grief inflicted on individuals and families by their use? I think the answer is pretty obvious, given the fact that Susan Davis represents San Diego, which is the largest concentration of PHARMACEUTICAL companies in the entire country! THE DRUG INDUSTRY LOVES THE ALCOHOL AND CIGARETTE INDUSTRIES. Alcohol and tobacco usage results in SICKNESS, and reducing alcohol and tobacco related disease would REDUCE drug sales and drug company profits. THE DRUG INDUSTRY HATES THE DIETARY SUPPLEMENT INDUSTRY. Nutritional supplement usage results in WELLNESS, and increasing healthiness REDUCES drug sales and drug company profits. It's as simple as that! What we need at this juncture in our nation's history, is to elevate DSHEA to the status of a Constitutional Amendment, so that if ADULETERATED LEGISLATION like this incredibly evil Bill is passed, it can be immediately struck down. Richard Brodie |