FDA SIDING WITH BIG MEDICINE TO CONTINUE PROSTATE CANCER ILLNESS!
FDA Postpones Decision on Lycopene/Cancer Health Claim for a Fifth Time
SAN DIEGO, CALIFORNIA - The FDA has requested a fifth extension on giving a decision on American Longevity’s health claim petition on the link between lycopene and a reduced risk of developing certain types of cancer until October 10, 2005.
American Longevity has compiled scientific studies indicating that consumption of tomatoes, tomato-based products and lycopene supplementation may reduce the incidence of prostate, lung and stomach cancers and submitted these to the agency in 2003, along with its petition.
A decision was initially expected on December 24, 2004. However in mid-December the agency informed American Longevity that the decision would be delayed until February 11, 2005, again until April 12, 2005, again until June 12, 2005, yet again until August 12, 2005 and finally they have requested an additional 60 day extension. In recent months the agency has asked for extensions in its review of seven other pending qualified health claim petitions citing a lack of agency resources.
In a letter dated July 7, U.S. Senators Tom Harkin and Orrin Hatch wrote Dr. Lester Crawford, the commissioner of the Food and Drug Administration (FDA) expressing their concern about the length of time it takes to get an approval for Qualified Health Claim Petitions. The letter specifically asked how many petitions the FDA currently had, the length of time it has taken to approve each one, how many full-time equivalents (FTEs) are devoted to review them and the grade levels of the reviewers. The senators offered the disposal of their staffs to meet with the FDA to solve the problem.
“To say that we are disappointed by this fifth request for an extension would be an understatement” states Steve Wallach of American Longevity. “Every extension further delays our ability to get this important information out to the general public. However, we look forward to getting approval on this lycopene/cancer health claim petition in October.”
American Longevity has submitted several Health Claim Petitions to the FDA and is responsible for the authorized Health Claim Petition for Selenium and its relationship to Cancer Risk Reduction. American Longevity has helped to defend the Health Claim Petition process through the courts and has submitted many official comments to the FDA on behalf of the nutrition industry, all in an effort to help consumers have more access to truthful information in order to base a more informed decision regarding their own health and wellness.
American Longevity is a leading designer of Dietary Supplements and cutting edge personal care and wellness lifestyle products. The company was founded in April of 1997 in San Diego, California by Joel D. Wallach BS, DVM, ND, and Ma Lan MD, MS. American Longevity markets its products worldwide, through a network of independent distributors.
HEROES/HEROINES FIGHT FDA - GET OMEGA 3 CLAIM APPROVED
9 Sept 2004 -- After the FDA got beat in court by these good guys, on the selenium health claim, the FDA learned not to suck lemons! Yesterday the Food and Drug Administration (FDA) authorized their qualified health claim linking consumption of omega-3 fatty acids with a reduced rate of coronary heart disease:
FDA APPROVED CLAIM
“Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.]
The announcement follows FDA consideration of a health claim petition filed by American Longevity and Life Extension Foundation Buyers Club seeking to amend the agency’s previously authorized health claim for omega-3 acids and Coronary Heart Disease (CHD).
The September 8th decision dramatically widens FDA’s former position regarding the relationship between dietary supplements containing omega-3 fatty acids and the resulting reduced risk of CHD. The former qualified health claim contained a substantively limiting disclaimer that failed to adequately assess the benefits of omega-3 fatty acids in reducing the risk of CHD. The FDA’s current qualified health claim more accurately describes the current state of the scientific evidence on the benefits of omega-3 fatty acids and extends use of the health claim to both dietary supplements and conventional foods. A copy of the FDA letter allowing the use of the claim may be obtained from Cynthia Lewis at Emord & Associates, 202-466-6937.
Now why didn't your company join in putting in this petition? It can be used by everybody in the industry but only Doc Wallach and Dirk Pearson/Sandy Shaw had the guts and money to do it for the good of the people in the United States. They are also the only nutritional companies to have nerve enough to sue the FDA in the past. See the article below, they are the only companies to fight the bad guys. Now you can tell your company they can use the claim above because it is public property. However, before your company uses it make them send $5,000 to Emord and Associates to defer part of the thousands spent getting this claim
through.
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Now this makes me MAD! The FDA puts out a news release making it look like it was their
idea to approve the claim. This is the ultimate in PR slime by a federal agency that obstructs
nutritional claims right and left! If it had not been for Doc Wallach and Dirk Pearson/Sandy
Shaw the FDA would have never done it!!!!! (@#@#$% !!!!!!) Slimy news release by the FDA: http://www.fda.gov/bbs/topics/news/2004/NEW01115.html
Notice the FDA says this is the SECOND approved claim for a nutritional food they approved.
YES! After the FDA was sued in court and defeated by Doc Wallach and Dirk Pearson/Sandy
Shaw on the FIRST claim (selenium)!
Already this morning two other companies are trying to take credit for this hard work and
money spent. Kraft Foods put in a "neutral" comment during the submission, that was
OK. But, Martek Industries put in an "objection" that the only way EFA's could be gotten
was by using their seaweed extract. This caused another $10,000 to be spent over several
months. Think this was their objection. This was after a healthly six digits had been paid out to fight the FDA! Put Martek on your bad list! Tell your company not to buy anything from Martek.
GOOD GUYS BEAT BAD GUYS TRYING TO DESTROY YOU!
6 Aug 2004 – YES! Two bad groups (1) the Center for Science in the Public Interest (read that PUBLIC HARM) and (2) Public Citizen, had their lawsuits against YOU dismissed. These evil dummies were trying to require nutritional foods to have the same testing as drugs for you to be able to say ANYTHING about them. They are obviously in the influence of the big drug companies so they fall under the heading of “Enemies of the People.”
30th July 2004 – The U.S. District Court for the District of Columbia dismissed (Slimeball #1) Center for Science in the Public Interest and (Slimeball #2) Public Citizen’s lawsuit challenging FDA’s qualified health claims process for foods. The Hero's of this battle against the villains are:
Julian M. Whitaker, M.D.;
Life Extension Foundation - Durk Pearson and Sandy Shaw;
American Longevity, Inc. - Doc Wallach
These good folks intervened in the case on the side of the FDA to defend the right to make qualified health claims consistent with the U.S. Court of Appeals’ decision in Pearson v. Shalala. Great! Go ask your company where they were when this battle occurred! Tell them they need to get of their “toozies” and help protect your business!!!! If your company wants to join in the battles against anti-nutritionists have them check with me.
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