Topic

FDA

49 petitions

Update posted 1 month ago

Petition to Food and Drug Administration

Require companies to list all food ingredients CLEARLY -- no NATURAL FLAVORS blanket term.

I am allergic to more than 20 different types of food, including some that are allowed under the blanket term of "NATURAL FLAVORS."Some uncommon allergies to foods that I have are: Garlic, Squash, Spinach, Casein, Grapefruit, Cantaloupe, Honeydew, Orange, Rice, Salmon, Both Nut Mixes (does NOT include Peanuts), Baker's Yeast, Pork, Poppy Seed, Bean Mix, Carrots, Peppers (NOT peppercorns used for ground peppers) and Tomatoes.These foods are NOT required by the Food and Drug Administration to be listed as "May Contain" foods and may also fall under the blanket term of "Natural Flavors." Having the blanket term of "Natural Flavors" allows companies to put more than 1,000 foods under this category, which may not be known to someone with a lot of food allergies, such as myself and many others. This can be very harmful to us and even deadly. As I write this, I have just gotten home from the hospital for an allergic reaction to a food that is allowed to be listed under "Natural Flavors," which, unlike additives and spices, are not listed in the FDA knowledge base. I have no idea what my caused my allergic reaction because of this and it put my life at risk. NO ONE should have to live in fear of what they eat. Companies need to put all of their ingredients on their label, regardless of possibly revealing a "secret recipe." Keep a "secret" safe is not worth the life that may be taken from a person with a food allergy.

Corii S
115 supporters
Started 3 months ago

Petition to General Electric, Janet Woodcock, M.D., United States Department of Health and Human Services

PREVENT FDA FROM APPROVING CONTRAST DYES WITHOUT THE MANDATORY VASCULAR INJURY BIOMARKERS

I was severely injured by a contrast dye injection called OMNIPAQUE. The chemical damaged and burned all my superficial blood vessels in my body. It was a toxic poison. A chemical is considered a poison when it affects a body system. It damaged both my cardiovascular and nervous system. Due to this severe injury, my autonomic nervous system activated and I went into compensatory shock. I suffered with profuse night sweats for six weeks following the injection. I suffered with excruciating full body pain, burning, severe aching, cramping and vascular constriction throughout my entire body. All my joints began to swell.  I had chronic blood loss for over 15 months. I was getting blood clots. I was building up with full body edema. I could no longer regulate my body temperature. I did not sleep for two years and was bed ridden and left to die at home. I had both signs and symptoms and was ignored by the medical community. The medical professionals turned their backs not only because I was injured by a pharmaceutical drug, but the main reason I was not provided any medical treatment was due to the fact there are no biomarkers for vascular injury.  How could the Federal Drug Administration approve a chemical contrast dye which is injected into the vessels and which can damage those vessels without a necessary vascular biomarker in case a patient is injured internally.  A biomarker is a measurable substance in an organism whose presence is indicative of some phenomenon such as disease, infection, injury or environmental exposure. A biomarker is an integral part of the drug discovery process.  At 15 months into this severe injury, I was in lactic acidosis, I had a shock index of 0.9 and I had tachycardia and was turned away by a vascular physician.  I was a healthy woman before this contrast injection. The chemical destroyed all my superficial blood vessels. I was provided no pain management or physical therapy. On the Omnipaque drug facts, it states can cause chemotoxic injury to vessels and organs. I want to know how the FDA can approve an intravascular injection which can damage blood vessels without a required vascular biomarker. I do not understand how contrast dye injections can gain approval without a drug induced vascular injury biomarker. How do they pass the first clinical trial?  I was treated worse than a lab rat by all the medical professionals. All contrast dyes have the potential to damage blood vessels. The contrast dye injections need to be stopped until a vascular biomarker is discovered. More people will be harmed and provided no treatment for their injuries. This photo was taken 31 months after my severe injury. I am still suffering with damaged vessels, chronic pain and neuropathy. Let's make a change before more innocent people are damaged by the contrast dye poisons. Let's stop the FDA from approving the intravascular contrast dye injections until the proper vascular biomarkers are discovered.       

Injured Victim
8 supporters
Update posted 3 months ago

Petition to Food and Drug Administration, President of the United States

Approve Hyperbaric Oxygen for Off-Label Conditions (Cerebral Palsy, Autism, MS, etc.)

Petition Updates and Part 1 of Description: UPDATE #1 (6/21/2017): Please scroll down past this description to read my first petition update in the "Updates" section entitled "My First Petition Update!" to read about the fraudulent study conducted by Dr. Jean-Paul Collet in regards to hyperbaric oxygen therapy and cerebral palsy (CP)!  We need to call Collet out on his injustice and demand that he revise the study's text to promote the truth that hyperbaric oxygen CAN treat CP! UPDATE #2 (6/21/2017): Please scroll down to view my second update about you (and other supporters) promoting this petition! :)  We need to get as many signatures as possible to get the FDA labeling regulations changed! *Photo on main page of petition from the Colorado Center for Hyperbaric Medicine [3]* Hi! My name is Christian Huber. I am 17 years old, and I have written a petition! Would you please take the time to read, and sign it if you support it? It would help me, and so many others with brain injuries! :) “I have officially diagnosed your son with mild cerebral palsy,” said the doctor.  At that very moment, my life changed, and so did my parents’ lives.  Because I shared my mother’s womb with my identical twin who died, I was born two months prematurely on October 8, 1999.  As a result, my lungs weren’t fully developed, and I didn’t take one necessary breath when I was supposed to, and my brain suffered because of that loss of oxygen. My parents were unaware at that moment of how important that one breath of oxygen would be to my developing brain, and they would have no idea how it would affect me in the future.  Although mild, my cerebral palsy is a life-altering developmental disability[1] that has affected me since the day I was born. Fast forward 17 years from the day I was born, and my brain still hasn’t changed.  I still need assistance with skills that are considered to be easy to other people, such as finding something in the house, getting a knot out of my shoe, or doing any other life skill or activity that you could think of.  I currently take occupational therapy (OT) to work on those skills, and activities such as cooking corn muffins and making orzo salad.  One of my occupational therapists actually showed me how to wash my mom’s car, since that counts as a life skill, too!  He even said to me one time: “Everything’s OT,” meaning that every life skill I do, whether it’s washing a car or making a meal, is considered a part of occupational therapy. In addition to taking occupational therapy, I also currently take physical therapy so that I can loosen and strengthen my spastic leg muscles, improve my balance and coordination, run around the neighborhood, play basketball, and jump rope.  Even though these therapies are fun, sometimes I think that they aren't really helping, since I still wake up each morning with tight muscles and a brain that doesn't always work the way it should. Now that I am getting older, however, I am entering the transition phase from high school to college and the workplace.  As a result, in two years I will no longer be in school with occupational and physical therapy.  Although my parents love me very much, I can feel tension and the sense of urgency between my parents and I.  My dad sometimes mentions my age when I can’t do something by saying: “You’re 17 years old, you should know how to do this by now!”  I feel as if he sometimes doesn’t know how to take a deep breath, and calmly explain to me how to do something in a step by step way.  My mom is also getting nervous about my lack of life skills, despite my academic abilities.  She said to me just recently, “We are going to stay at home and work on life skills all summer.”  I would love to work on life skills all summer, but I need to heal my brain so that I can learn and grasp life skills quickly and easily.  Before I can pursue a neurological healing journey, however, I need the FDA to approve a treatment that has been proven to work: hyperbaric oxygen therapy, and I need all of you to sign my petition. References:[1] Surabian SR. Developmental disabilities: epilepsy, cerebral palsy, and autism. Journal of the California Dental Association. https://www.ncbi.nlm.nih.gov/pubmed/11484298 Published June 29, 2001. Accessed March 15, 2017. [3] TBI Therapy – Colorado Center for Hyperbaric Medicine. Colorado Center for Hyperbaric Medicine. http://www.cohyperbarics.com/tbi-therapy/ Accessed March 15, 2017.___________________________________________________________________Agreement in Which Petition Signer Abides By: If you sign this petition, you agree: That the FDA should approve hyperbaric oxygen therapy for cerebral palsy and other off-label conditions That insurance companies should pay for hyperbaric oxygen therapy so that patients living with off-label conditions can receive it free of charge ___________________________________________________________________ External Resources: Conditions for HBOT (long list that I found!): https://oxfordhbot.com/treatment-indications/ Collet Study Fraud from the Quebec Association of Hyperbaric Oxygen Therapy: http://www.therapiehyperbare.com/en/index_en.html Georgia Medicaid Court Decision (in which father David Freels and his brain-injured son got reimbursed for HBOT treatment): http://davidfreels.com/pdfs/files/GeorgiaMedicaidDecision.pdf Direct Testimony of Pierre Marois, M.D during Georgia Medicaid Court Decision: http://www.therapiehyperbare.com/images/hyperbare/2006-06_georgia_medicaid_dr_marois.PDF David Freels (father of son with brain injury who was reimbursed by Medicaid for HBOT): http://davidfreels.com/ Medicaid for Hyperbaric Oxygen (HBOT) Yahoo Group: https://beta.groups.yahoo.com/neo/groups/medicaidforhbot/info?referrer=StemCells Mums National Parent-to-Parent Network (HBOT advocacy group): http://www.mums-network.org/index.htm Chamber of Hope providing free HBOT in Florida to families: http://cpfamilynetwork.org/resource-tag/free-hyperbaric-oxygen-therapy/ AND http://cpfamilynetwork.org/resources/chamber-of-hope-charity-providing-free-hyperbaric-center-for-children-inc-florida/ Nano-devices that cross blood-brain barrier open door to treatment of cerebral palsy, other neurologic disorders (scientific study): https://www.sciencedaily.com/releases/2012/04/120423104015.htm (Oxygen could be placed inside these dendrimers to cross blood brain barrier as an alternative to hyperbaric oxygen and ozone therapy)  

Christian Huber
196 supporters