|
|
|
The FDA is currently
throwing away the Constitutional Rights of American Citizens. Read the
following articles to find out how?
Cooking with Stevia has been banned by the FDA. The Dallas District Office of the FDA has order the Stevita Co., Inc. to destroy the "Cooking with Stevia" cookbook as well as two other books pertaining to Stevia. Following this order, Agents of the FDA were sent out where they DEFACED the remaining Stevita Co., Inc. inventory of the "Cooking with Stevia" cookbook so that they could not be sold. Who gave the FDA authority over the US Constitution? The FDA Caught in more lies!
FDA UPDATE! Once Again, the FDA is trying to cover its lies with more lies! Here is the proof! Please read these letters to get the idea of what is going on. * FDA orders the destruction of Stevia books! Department of Health & Human Services Public Health Service, Food and Drug Administration Dallas District
May 19, 1998 VIA FACSIMILE AND FEDERAL EXPRESS Mr. Oscar D. Rodes, President
Dear Mr. Rodes: This letter is written in response to the May 13, 1998, letter by Ms. Jaylene M. Sarracino, Esq., addressed to the attention of Ms. Stella Notzon of this office, on the subject of further detainment of Stevita Co. stevia products under Entry Numbers 125-0981854-3 & 125-0981567-1. Ms. Sarracino's letter documents a telephone conversation with Ms. Notzon on the subject of cookbooks and other publications used in the marketing of your stevia products. In her letter, Ms. Sarracino states that on May 14, 1998, Stevita Co. will discontinue the sale of any publications, and will sever all links to web-site information referencing the questionable use of stevia products. She indicates the stevia products will be marketed strictly as dietary supplements with only the labeling currently appearing on the product containers. The agency appreciates Stevita Co.'s expressed intention to comply with the Law. However, a current inventory must be taken by an investigator of this office, who will also be available to witness destruction of the cookbooks, literature, and other publications for the purpose of verifying compliance. Additionally, your stevia products currently in distributor and retail channels with the offending cookbooks, literature, and other publications continue to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products are unapproved food additives in violation of Section 409, and adulterated within the meaning of Section 402(a)(2)(C) of the Act. We are prepared to pursue further regulatory action against these products should they continue to be adulterated in distribution. The inspection of your facility on April 27, 1998, conducted jointly by investigators of the Food and Drug Administration (FDA) and the Texas Department of Health, along with visits to your consignees, documented your firm's continued marketing of your stevia products as conventional foods accompanied by offending literature, cookbooks, and other publications, in violation of the Act as cited in the FDA warning letter of March 6, 1998. Further regulatory action will be considered against new shipments of stevia products marketed in this manner, as well as against those parent lots from which the adulterated products are being marketed. If you have any questions regarding this letter, you may call me at (214) xxx-xxxx ext. xxx. Sincerely, James R. Lahar Compliance Office cc: Jaylene M. Sarracino, Esq.
* Letter to Senator Phil Gramm Oscar Rodes May 22, 1997 The Honorable Senator Phil Gramm
Dear Senator Gramm, Please refer to the attached order from the FDA Dallas office ordering us to destroy publications (in this case 3 books written and published by third parties). We buy these books from the publishers and resell them to our customers. These books provide general information about the plant Stevia, its history, usages and scientific studies around the world. Also, we sell dieatry supplements based on the Stevia herb. FDA officials allege that the presence of the books renders the stevia products adulterated and hence unsafe for public consumption (as if the books have magical powers). Our legal counsel, Mr. James Turner, (202) xxx-xxxx is reviewing the provisions of the DSHEA act of 1994 to determine the legal remedies we have to protect ourselves from this Nazi-like action by an agency of our government. I am sure you agree that probably this action tramples on our First Amendment Rights and I hope you will take immediate action to investigate who and why is ordering this repulsive action in a democratic country. Sincerely yours, Oscar Rodes * Response from Senator Gramm with the response from the FDA! Phil Gramm - Texas
September 9, 1998 Dear Mr. Rodes Enclosed is the reply I received from the
Food and Drug Administration in response to my earlier inquiry on your
behalf. I hope this will be useful to you.
Yours respectfully, Phil Gramm
Department of Health & Human Services Public Health Service, Food and Drug Administration
Food and Drug Administration
September 4, 1998 The Honorable Phil Gramm
Dear Senator Gramm: This is in response to your inquiry of June 2, 1998, on behalf of Oscar Rodes of Arlington, Texas, concerning the use of stevia as a sweetener in food, and concerning voluntary actions proposed by the Stevita Company of Arlington, Texas, to come into complaince with the labeling requirements for dietary supplements. These proposed actions were in response to detentions of its imported products and a warning letter from the Food and Drug Administration (FDA or the Agency). FDA has had contact with the Stevita Company over several years about the company's importation, sale, and marketing of stevia. It must be stated first that FDA has never ordered the destruction of Stevita Company cookbooks, or any other books related to stevia, as has been alleged. In order to reiterate Agency practice and procedure regarding the disposition of publications implicated in compliance or enforcement actions, FDA issued a memorandum to remind employees in the field of Agency policy on the disposition of such publications. A copy of this memorandum in enclosed. Stevia may be sold in the United States as a dietary supplement, but not for any use in food, including use as a sweetener. The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the term "dietary supplement" to exclude products represented for use as conventional foods. DSHEA also excluded dietary ingredients in dietary supplements from the definition of "food additive" in the Federal Food, Drug, and Cosmetic Act (FD&C Act). Accordingly, a product represented for use as a sweetener in food is not a dietary supplement and is subject to the food additive provisions of Section 409 of the FD&C Act, unless it is generally recognized (GRAS). Stevia is not an approved food additive, and FDA does not believe it to be GRAS. For these reasons, the Agency established Import Alert #45-06, Automatic Detention of Stevia Leaves, Stevioside (extract stevia leaves) and Food Containing Stevia, on May 17, 1991. Following the DSHEA in 1994, FDA revised Import Alert #45-06 to clarify that stevia could be imported only for use as or in a dietary supplement. In March 1998, FDA issued a warning letter to Stevita Company about its marketing of stevia with promotional literature, such as a Stevita Company cookbook, which described the sweetener use of Stevita Stevia in food. This type of promotional literature, all of which referred to Stevita Company stevia, is considered labeling under the FD&C Act. Because such literature represented the stevia products for use as a sweetener, i.e., as a conventional food, it rendered the products unapproved food additives under the FD&C Act. Subsequently, FDA detained some stevia that the Stevita Company was intending to import. In reponse to the warning letter, the attorney for Stevita Company informed FDA of the company's intention to cease marketing stevia with Stevita stevia cookbooks and other promotional literature in question, and to conduct a withdrawal of the books and literature from its retailers for return to the Stevita Company. In a voluntary compliance situation, such as the subject Stevita matter, the disposition of any printed materials that function as labeling is the prerogative of the manufacturer, distributor, wholesaler, or retailer. It is standard practice for FDA to verify activities agreed to by manufacturers and distributors in order to come into compliance with the requirements of the FD&C Act. Stevita Company had a number of available options for bringing its activities into compliance. Because FDA believed that the company inteded to destry its remaining inventory of promotional literature, FDA advised the company that it was available to witness such compliance activity should the company choose that alternative. This notification may have been based on a misunderstanding of the company's intentions; however, at no time did the Agency request or require the destruction of the cookbooks or any other related literature. On June 29, 1998, the Agency informed Stevita Company's attorney that it was releasing the detained stevia because Stevita Company had relabeled its stevia products, had ceased marketing them with materials that represented them for use as a sweetener in food, and had agreed to a market withdrawal of such materials. In that letter, FDA specifically reminded the company that there are ways of selling stevia cookbooks that do not cause them to become labeling for Stevita's products. We hope this information is helpful. Sincerely, Melinda K. Plaisier
The first letter from a James Lahar specifically states that the FDA will be available to witness the destruction of the cookbooks, i.e. Cooking with Stevia. No other option is given. In the FDA's response to Senator Phil Gramm, the FDA denies ordering the destruction of the Cookbooks and even state that the cookbooks were Stevita Company Cookbooks. This is false. The Stevita Company did not publish the cookbooks, they simply purchased the books from the Author, James Kirkland. Stevita Company was simply distributing the cookbook for James Kirkland as well as two other books on stevia with recipes. In the response letter from the FDA they state "the attorney for Stevita Company informed FDA of the company's intention to cease marketing stevia with Stevita stevia cookbooks and other promotional literature in question, and to conduct a withdrawal of the books and literature from its retailers for return to the Stevita Company." After talking with Mr. Rodes, he informed me that the FDA not only ordered the withdrawal of the books from sale, but the FDA also ordered a RECALL of all books and literature. As for inventories being held by the FDA, the Stevita Company never relabeled the two shipments in question because they already had approved labels prior to shipment from Brazil. So why was the shipment held if the shipment already met FDA labeling requirements? And where does this leave James Kirkland and his Cooking with Stevia cookbook? It is continuing to be sold via the Internet and Nutri Books out of Denver, Co.
Secure Ordering Ordering
Of Great Stevia Products Through Our
|
