Anti-Biotech Food Activists’ Drive for Mandatory Labeling Takes Double Hit

Genetically enhanced wheat

Opponents of agriculture biotechnology have been loudly hailing the certification of a mandatory genetically enhanced food labeling ballot initiative in California. But two largely unreported setbacks in recent weeks should give these activists pause, as these develoments threaten both their public relations and legal strategies in California and elsewhere.

The first setback came from the June annual meeting of the American Medical Association (AMA). There, the AMA reaffirmed its long-standing perspective that “there is no scientific justification for special labeling of bioengineered foods, as a class, and that voluntary labeling is without value unless it is accompanied by focused consumer education.” That conclusion was based on the AMA’s belief that “There is no evidence that unique hazards exist either in the use of rDNA techniques or in the movement of genes between unrelated organisms.” The AMA certainly is not shy about taking public positions which support activist causes, even where the science doesn’t support those positions. Consider, for instance, its June resolution backing the concept of using soda taxes to curb obesity. So its statement on genetically enhanced foods (GE foods) is a substantial blow to the anti-biotech crowd.

The second setback came from the U.S. Senate and its vote on an amendment to S.3240, better known as the “Farm Bill”.  The Senate considered and voted down (by 73-26 vote) an amendment Senators Bernie Sanders (Vt.) and Barbara Boxer (CA) introduced which would clarify States’ authority to adopt mandatory GE food labeling. Earlier this year, Vermont’s legislature considered and eventually dropped a bill to mandate labeling (see this Legal Pulse post on the bill). One argument made against the bill was that the Food & Drug Administration’s (FDA) determination not to require GE food labeling foreclosed the States’ ability to require such a label. The Senate’s rejection of the Sanders/Boxer amendment adds weight to this preemption argument, and may provide ammunition to the opponents of the California initiative, who are already threatening a legal challenge if it’s adopted.

As we wrote in the February 2011 post Mandatory Labeling of Genetically Enhanced Foods: Why It’s Not on the Policy Menu:

Food labels carry a great deal of weight with consumers.  What must be included on the ever-shrinking real estate of those labels must be based on sound science and the need to protect public health, not on the ideologically stoked fears of activists.”

The Senate and the AMA, following FDA’s lead, thankfully continue to base their decisions on science and what’s best for public health.

3 thoughts on “Anti-Biotech Food Activists’ Drive for Mandatory Labeling Takes Double Hit

  1. You have got to be kidding. In reality, the FDA’s “decisions” are often political and not based on any sound science. Moreover, they tend to accept the studies submitted by the industries they r4egulate as if they are scientifically sound and appropriate and provide the information required by law when nothing could be further from the truth.
    For example since 1973, the FDA’s own regulations have required that drug companies must proove that any compound used as a preservative in a biological product (including vaccines) must be proven to be “sufficiently nontoxic ..” as set forth in 21 C.F.R. Sec. 610.15(a). Rather than require the vaccine makers to conduct and submit the requisite toxicological studies to establish the appropriate NOAEL (no observed adverse effect level) values for the use of Thimerosal as a preservative in vaccines and other biological drug products, the FDA has allowed the companies to violate the applicable laws regulating its own conduct in approving Thimerosal-preserved vaccines (21 C.F.R Sec. 601.4(a)) as well as the laws regulating the information that the vaccine makers must submit (21 C.F.R. Sec. 601.2(a)). Since all of the 21 CFR Sections from 600 through 680 are CGMP regulations, in 2011, the FDA violated the fundamental tenet, as set forth in the Preamble to the 1978 revisions to the CGMP regulations, that such regulations must be minimum requirements, by modifing 21 CFR Part 610 to add a Section at 21 C.F.R. Sec. 610.15(d) allowing FDA administrators to grant exemptions to any provision in 21 C.F.R. 610.15 whithout establishing any process or requirements for such other than the mnanufacturer must ask for the exemption and, needing no justification, the FDA administrators can grant the manufacturer’s request. IF there is no applicable NOAEL value for Thimerosal, then one cannot scientifically establish the “nontoxic level” for this use of Thimerosal much less the lower level in a vaccine dose delivers a Thimerosal dose that is “sufficiently nontoxic …”, where for organic mercury compounds like Thimerosal, which is a highly toxic compound and a proven human carcinogen, mutagen, reproductive toxin, teratogen, immune system disruptor and allergy sensitizing agent at doses that, on a mercury basis, are less than 0.05 microgram of mercury per kilogram of body/tissue weight [see: http://mercury-freedrugs.org/docs/20120514_The_AnythingButMercury_Realities_b.pdf%5D.
    If you do not like the preceding example, then, the realities concerning the drug products Celebrex, and Vioxx, what the companies submitted, what the companies withheld, what the FDA “swallowed hook, line and sinker”, the thousands that have been seriously injured and died and, in the case of Celebrex, are still dying and being harmed clearly that the FDA is not a science-based organization.
    If you or I knowingly gave people a “herbal” product that we knew was more lethal than the existing drug products for minor pain and people died, then we would probably be criminally prosecuted for wrongful death or negligent homicide. But, when drug companies knowingly markets drug products that are less safe than the existing drugs for a given pain indication, all the firms have to do is pay a fine that is typically less than 10 cents on the dollar for the profits they have made and, in some instances, are continuing to make – but no executive in the drug firms involved has been tried, much less convicted and sent to jail. Nor has the federal government seized these firms under the Criminal RICO statutes, which, because they have a pattern of knowingly violating the regulations governing the manufacturers’ lawful operation, the drug firms have clearly violated.

  2. Pingback: WLF Web Seminar Today, Live Broadcast 1:00 p.m. « The Legal Pulse

  3. Pingback: WLF Web Seminar Delved Into Constitutional Problems with Forced Biotech Food Labeling « The Legal Pulse

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