Posts Tagged ‘FDA’

Saturday, February 20, 2010 @ 05:02 PM
posted by Rudi Leonardi

“Being Italian, (as you can tell from my surname Leonardi) I do not want McCain’s Bill or the FDA to take away my garlic …or other healthy supplements for that matter – this bill really stinks.  Take Action Now!” ~ Rudi Leonardi

It is important to highlight a few key dangerous points and considerations that support the POP perspective pertaining to Senator McClain’s S 3002 Bill, “The Dietary Supplement Act of 2010”. It is ESSENTIAL to act NOW and to show the strength of our pushback so other Senators and members of Congress do not support or co-sponsor this bill.

DSHEA, historically, is based on an intent and established framework that supports the concept that dietary supplements are generally safe….We know that there are dangerous ingredients that could be placed in supplements by unscrupulous and money-grubbing companies and individuals. There already are guidelines in place to protect us.  We know that there are many ingredients that have to be tracked – a huge job, but it can be done – we are fortunate to have great resources to help us find the truth.  For example, Dr. Brian Clement’s latest book “Supplements Exposed” is an excellent resource. (See popcampaign.org for the full article.)

DSHEA legislation already allows the FDA to evaluate each ingredient in a supplement to determine if it presents an unreasonable risk of injury or illness.  It already has an approval process in place and is alerted to major problems. Key here is that, if a “signal” is sent and detected that a product needs to be reviewed, then the FDA can decide the next step, coordinate with existing other agencies, conduct its own research, gather its “sensible facts”, and act….  DSHEA allows the FDA the discretionary power to do what is necessary to protect us.  (See reporting requirements in articles on popcampaign.org)

The “signal”:   “Serious” vs “Non-Serious” Adverse – Could mean Anything?

On page 7, lines 16 & 17, the McCain bill states: “…striking ‘‘SERIOUS ADVERSE’’ and inserting ‘‘ADVERSE’’.  The signal changes dramatically and dangerously. DSHEA currently states “SERIOUS” adverse effects trigger enforcement.

“Serious” is defined as:

… any experience resulting in any of the following outcomes: death, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes previously listed (in accordance with 21 C.F.R. § 600.80 [2002] and 21 C.F.R. § 314.80 [2002]).

Without “serious” in the text, the FDA signal to act is instructed as “adverse,” which can be ANYTHING that happens ANYWHWERE in the world. It could be interpreted that supplements that interfere with prescription drugs are powerful enough to interfere with the stability of the human condition, could be equally dangerous and cause an “adverse” problem. This means that if someone in China gets sick (yes even 1 person of the 2 billion plus) because he/she suffered a stomachache because of an over abundant supplement of soy in the food, this would be an “adverse” signal. If a European connoisseur of wine and cheese got ill because of a supplement of valerian to help sleep off a happy hangover, this would be considered an “adverse” signal. If someone in Africa reportedly got dizzy after taking yohimbe, this would be an “adverse signal”.  An “adverse: signal could be the effects of ginseng, garlic…WHAT?  Being Italian, (as you can tell from my surname Leonardi) I do not want McCain’s Bill or the FDA to take away my garlic …or other healthy supplements for that matter – this bill really stinks!

Yes, this is a grey area and could happen with the proposed amendments, the S 3002 bill allows the FDA to yank a product for the simplest reason or smallest event while reinforcing it’s modulated criteria and selective rationale with such articles as listed below be relied upon fully as evidence for banning supplements, with or without consideration of all elements:

Other dietary supplements shown to potentiate or interfere with prescription drugs include garlic, glucosamine, ginseng (Panax), saw palmetto, soy, valerian, and yohimbe.14 (((De Smet PA. Herbal remedies. New England Journal of Medicine. 2002;347(25):2046-2056.))

If amended, the FDA could also use any incident, report, finding, research, etc.  from another country to yang a product from a shelf and set policy in the United States. This would be consistent with the some of the WTO Codex efforts to control supplements in other countries. We do not want this here in the US. We must protect ourselves.

There is snapshot in Europe of what we Americans might look forward to if this bill passes – “…EFSA, the European Food Safety Authority, has sharply reduced the list of available supplements and is in process of reducing potencies to ridiculous levels, such as less beta carotene than can be found in half of a large carrot.” (European Legal Director Gretchen DuBeau working with ANHI).

Yes, there are money issues involved, reductions in government spending, and the perception (and facts) that the FDA is friendlier towards drug companies and less favorable to supplement businesses. Also, in his press release, Senator McCain references for his bill changes a GAO (Government Accounting Office) recommendations that came out in January 2007, from the previous Bush administration – these recommendations are believed by many to be biased and slanted to the industry drug giants. Many of these points will be discussed further as we continue our efforts to educate on this bill.

We still need to take action immediately.

Lastly – Athletes and Drugs

In his press release and citing his supporters of the NFL and Major League Baseball, Senator McCain highlights suspended Athletes – their situations being adverse signals”. Sports figures are used to signals from the quarterback, the center, and the backs, to the catchers, pitchers, managers and umpires.  Should we be sensitive that these athletes got their signals mixed up and that implementing this Bill will help these men on the field become more clear and allow them to make better health choices? There clearly is more to this. Does it not make sense that the athletes who were suspended purchased “illegal drugs”? Calling the Athletes confused and what they took as mislabeled supplements is really a backing away from the real issues of enforcement, illegal sales and use of steroids. Is the Sports industry trying to shift blame from the “US Anti-Doping Agency” (USADA) to the supplement industry, asking the FDA to get involved? Who is using whom to get what?

The time to ACT IS NOW!

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