A Warning Letter TO the FDA
Many U.S. consumers are dismayed at the actions of the FDA. Most citizens find various acts or lack of action by the FDA to be not only in the best interest of the public, but deplorable and unethical for a government agency. In most cases, consumers do not have legal ground to stand on. However, with the help of a tool the FDA commonly uses, consumers could finally have the legal footing to demand changes.
The FDA, as part of its duties to enforce the Food, Drug, and Cosmetic Act (the Act), routinely issues ‘Warning Letters’ to businesses and individuals that the government agency feels is in violation. New warning letters, as part of the Freedom of Information Act, are publically available on the FDA website, posted weekly. http://www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm
FDA Warning Letters typically explain to the recipient the findings of an FDA inspector, stating a company’s specific violations of the Act, and quoting particular laws. Most all FDA Warning Letters provide the recipient fifteen business days to correct the violations, and to provide the FDA with evidence of such corrections. Most letters as well warn the recipient that if ‘prompt action to correct the violations’ is not taken, failure to do so “may result in regulatory action without further notice such as seizure and/or injunction.”
While it is expected that the FDA should be in complete compliance of the Federal Food, Drug, and Cosmetic Act, a brief amount of research on the FDA website, proves that the FDA itself is in violation with respect to pet foods. Evidence is clear, that since February 2002 (at the very least), the FDA has knowingly violated the Act, allowing pet food to contain adulterated food ingredients. Millions of U.S. citizens every day handle dog foods or cat foods that by Federal Law are deemed adulterated; millions of U.S. pets consume them. (For further information, please see Warning Letter below.)
Many consumers are outraged at the actions of the FDA, for a multitude of reasons. Millions of U.S. consumers question the FDA’s logic restricting health supplements, while taking years to restrict possible melamine tainted Chinese ingredients into the U.S. Many suspect FDA executives’ pockets are lined with hush money from every industry; everything from pharmaceutical companies to pet food. In almost every one of the countless instances of questionable behavior by the FDA, there is a loophole that seems to provide the FDA a legal excuse supporting their actions; that is except for pet food.
There is no valid legal or ethical reason the FDA should and can allow adulterated ingredients into pet food. There is no legal loophole within the Food, Drug, and Cosmetic Act that allows for such actions. There is no valid legal or ethical reason the United States Congress should not demand the FDA executives be held responsible for these actions; charging them with full and complete penalties for every year this crime has continued. There is no valid reason every State Attorney General in the U.S. should not file charges against the FDA in representation of their citizens. Furthermore, there is no valid reason that U.S. Consumers should not be empowered with the same privilege that the FDA is provided, to send the FDA a Warning Letter, notifying them they are in violation of Federal Law.
There may be many issues consumers disagree with the FDA’s actions on; however, these issues with pet food, unfortunately, seems to be the only issue consumers have a legal ground to firmly stand on. Every U.S. consumer has the right, perhaps even the responsibility, to send the FDA a Warning Letter; regardless if they are a pet owner or not. Using the very same protocol followed by U.S. FDA inspectors, the director of the FDA should receive a registered or certified Warning Letter from every concerned U.S. Consumer, notifying them they are in violation of Federal Law, and notifying them they have fifteen days to correct the violations and to respond to the sender. The FDA should be warned, just as they warn businesses who violate the Food, Drug, and Cosmetic Act, failure to do so may result in “regulatory action without further notice such as seizure and/or injunction.”
Below you will find a Warning Letter to the Commisioner of the FDA, following the exact format and language of typical FDA Warning Letters. If you are a concerned consumer, and have ever doubted an action of the FDA, you are encouraged to copy and paste the letter into a document, add your name and mailing address at the top right of the page, add the date, and add your personal information in the last paragraph. Mail to the address provided, certified or registered mail to provide you legal proof the FDA received your letter. It is recommended to mail a copy of the letter to your State Attorney General’s Office, and your Representatives in Congress.
The FDA, in its design, works to protect U.S. consumers. Clearly their ‘work’ is questioned frequently. While many issues might disturb you, this issue with pet food is a crystal clear violation of the Food, Drug, and Cosmetic Act. The FDA violates Federal Law by allowing adulterated foods to become pet food ingredients.
Should the FDA ignore your letter, and not respond within the defined period, your State Attorney’s office should be notified. As a U.S. citizen, you are entitled to safe ‘food’ as defined in the Food, Drug, and Cosmetic Act. Legal action, by your State Attorney’s office, should be initiated to protect you. There is no legal loophole for the FDA to escape this; there are no legal loopholes to prevent U.S. citizens from obtaining the legal protection of their State Attorney General should it come to that. Please send your certified mail Warning Letter to the FDA, along with copies to your Congressional Representatives and your State Attorney’s office; every U.S. consumer deserves to be protected.
Any concerned individual residing in a country outside the United State yet has available on their store shelves pet foods and/or treats manufactured in the U.S., are encouraged to contact your government’s consumer protection entity and file a complaint regarding the U.S. Food and Drug Administration’s violation of Federal Law.
(Your Full Name)
(Your Street Address)
(Your City, State, Zip)
Dr. Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
5600 Fishers Lane
Rockville, Maryland 20857
Dear Dr. Eschenbach,
In late October, 2008, U.S. consumers conducted an investigation of the U.S. Food and Drug Administration (FDA) website, http://www.fda.gov. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the internet through links on your own website, www.fda.gov.
We found that you allow pet food to contain ingredients that are adulterated. Under section 201(f)(1) and (3) of the Act, the term ‘food’ is defined as “articles used for food or drink for man or other animals,” and “articles used for components of any such article.” The Act Section 402 (a) clearly defines an adulterated food; “A food shall be deemed to be adulterated – (a) Poisonous, insanitary, or deleterious ingredients.” (a)(5) “if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter.”
Specifically, our investigation revealed that since your report ‘Food and Drug Administration/Center for Veterinary Medicine Report on the risk from pentobarbital in dog food’ dated February 28, 2002 you have knowingly allowed adulterated foods for dogs to be introduced into interstate commerce; a direct violation of Section 301 (a)(c). In reference to Section 301(c), “The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise”, your violation of the Act has as well put countless pet food retailers in violation of Federal Law.
Although we suspect your organization has allowed adulterated food ingredients to become pet foods prior to February 2002, the above document provides clear evidence that every day following your Pentobarbital in Pet Food report, the FDA/CVM has been directly responsible for the continued violation of the Act Section 402(a). Your pentobarbital report clearly states your Organization scientifically proved pentobarbital, a euthanizing animal drug, was found in various samples of dog foods, and that your Organization suspects the source of the drug is from “euthanized, rendered cattle or even horses.” Any ‘food’ is considered adulterated by law containing a euthanized animal. Said report is sound evidence your Organization, at a minimum of six years, eight months since the publication of this report, violates the Act Section 402 (a), Section 402 (a)(5). http://www.fda.gov/cvm/FOI/DFreport.htm
We found further evidence on your website, clearly stating your organization understands the law, yet is ignoring the laws of the Act. “Pet food consisting of material from diseased animals or animals which have died otherwise than by slaughter, which is in violation of 402(a)(5) will not ordinarily be actionable, if it is not otherwise in violation of the law. It will be considered fit for animal consumption.”
Our investigation also found that in conjunction with AAFCO (American Association of Feed Control Officials), your organization is in violation of the Act Section 403. Quoting the Act Section 403 Misbranded food: “A food shall be deemed to be misbranded – “False or misleading label. If (1) its labeling is false or misleading in any particular, or (2) in the case of a food to which section 411 applies, its advertising is false or misleading in a material respect or its labeling is in violation of section 411(b)(2).” In complete ignorance of the Act, your organization flatly accepts AAFCO pet food regulation PF7; Nutritional Adequacy: (a) “The label of a pet food or specialty pet food which is intended for all life stages of the pet or specialty pet may include an unqualified claim, directly or indirectly, such as ‘complete and balanced’, ‘perfect’, ‘scientific’ or ‘100% nutritious’…” AAFCO Regulation PF7 is in direct violation of the Act. Your continued association and support of AAFCO regulations violates the Act Section 403.
The above is not intended to be an all-inclusive list of violations. As a government agency supported by tax dollars, you are responsible for ensuring that foods sold in the U.S. are in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice.
You should notify me in writing of the steps you have taken to bring your organization into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that had been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be directed to (Your Full Name, Your Street Address, Your City, State, and Zip). If you have any questions about this letter, please contact me at (Your Phone Number and/or Your Email Address).
cc: (Your State Attorney General’s office)
(Your Representatives in Congress)
Wishing you and your pet(s) the best,
What’s in Your Pet’s Food?
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