Bill Proposal: The FPIES Research, Transparency, and Clean Formula Act
Section 1: Title
This Act shall be known as the FPIES Research, Transparency, and Clean Formula Act.
Section 2: Purpose
The purpose of this Act is to:
- Increase research funding for Food Protein-Induced Enterocolitis Syndrome (FPIES) to improve understanding, diagnosis, and treatment options for this rare condition.
- Promote transparency in infant and toddler formula ingredients, ensuring that all formulas are made with clean, safe ingredients that do not exacerbate FPIES symptoms.
- Establish full insurance coverage for diagnosis, treatment, and management of FPIES, including nutrition support and specialized formulas.
- Raise public and medical awareness about FPIES and its impact on children and families.
- Ensure transparency regarding vaccines, their potential effects on individuals with FPIES, and affirm that vaccination is not mandatory in doctors’ offices, schools, or sports activities, respecting parental choice and informed consent.
This bill seeks to enhance scientific knowledge of FPIES, ensure the availability of safe nutritional options for infants and toddlers, provide necessary support to those living with the condition, and protect parental rights and informed decision-making regarding vaccinations.
Section 3: Definitions
For the purposes of this Act:
- Food Protein-Induced Enterocolitis Syndrome (FPIES): A severe, non-IgE-mediated food allergy that causes vomiting, diarrhea, dehydration, and shock in response to certain foods, typically in infants and young children.
- Clean Ingredients: Ingredients in infant and toddler formula that are free from artificial additives, preservatives, colorings, and potential allergens such as soy, gluten, and dairy that may exacerbate FPIES symptoms.
- Infant and Toddler Formula: Pre-packaged, liquid or powdered nutritional supplements designed for infants and toddlers who are unable to breastfeed.
- FPIES Research: Scientific studies focused on understanding FPIES, improving diagnosis, developing treatment options, and identifying causes and risk factors.
- Public Awareness Campaign: National and regional efforts aimed at educating the public, healthcare providers, and affected communities about FPIES, its symptoms, and available resources.
- National Institutes of Health (NIH): The primary federal agency responsible for conducting and funding medical research in the United States.
- Health Insurance Coverage for FPIES: Insurance coverage for the diagnosis, treatment, medical management, and nutritional support of FPIES, including formula costs and related treatments.
- Vaccines: Immunizations recommended by health authorities, including those against diseases such as measles, mumps, rubella, and influenza.
- Informed Consent: The process by which individuals or parents are fully informed about medical procedures, including vaccinations, and voluntarily agree or decline to proceed, particularly in contexts involving FPIES or other medical conditions.
Section 4: Establishment of FPIES Research Initiative
- National FPIES Research Program
- The National Institutes of Health (NIH) shall establish a dedicated research program for FPIES, with a focus on expanding the understanding of its pathophysiology, improving diagnostic methods, and developing effective treatment protocols.
- This program will support basic research, clinical trials, and clinical applications to improve the lives of individuals with FPIES and identify potential therapeutic approaches.
- Research Goals
The goals of the National FPIES Research Program shall include:
- Identifying the underlying causes of FPIES, including genetic, environmental, and immunological factors.
- Developing diagnostic tests for early and accurate identification of FPIES in infants and toddlers.
- Investigating potential treatments and therapies, including immunotherapies, dietary interventions, and pharmacological approaches to alleviate symptoms.
- Promoting collaborative research across academic, clinical, and industry sectors.
Section 5: Funding Allocation for FPIES Research
- Annual Funding for FPIES Research
- The federal government shall allocate an annual amount of at least $30 million for the National FPIES Research Program within the NIH budget. This funding shall be used exclusively for research, clinical trials, and development of diagnostic and treatment tools for FPIES.
- Grant Opportunities
- NIH shall offer research grants to universities, research institutions, and healthcare organizations to conduct studies on FPIES.
- These grants will focus on improving understanding of the condition, developing diagnostic technologies, and identifying treatment options.
Section 6: Public Awareness Campaign
- National FPIES Awareness Initiative
- The Centers for Disease Control and Prevention (CDC), in collaboration with the NIH, shall launch a national public awareness campaign to:
- Educate the public and healthcare professionals about FPIES, its symptoms, and the importance of early diagnosis.
- Raise awareness of the need for better nutritional options for FPIES-affected infants and toddlers.
- Provide educational resources to help families manage the condition, including support for families in choosing appropriate formulas and avoiding exacerbating allergens.
- Educational Materials and Resources
- The CDC will develop and distribute materials, including brochures, websites, and informational videos, to healthcare providers and families. These resources will educate about FPIES, available treatments, and dietary interventions.
Section 7: Clean Ingredients in Infant and Toddler Formula
- Requirement for Clean Ingredients
- All infant and toddler formulas sold in the U.S. must contain only clean, safe ingredients. Formulas must:
- Be free from artificial preservatives, colorings, sweeteners, or flavorings.
- Avoid the use of common allergens, such as soy, dairy, gluten, or other proteins that may trigger FPIES symptoms.
- Ensure transparent labeling that includes full disclosure of all ingredients, including sources of protein, fat, carbohydrate, and any additives used during processing.
- Transparency in Labeling
- Formula manufacturers must provide clear and comprehensive ingredient labels that include the sourcing and processing methods of each ingredient.
- Labels must be easily readable and understandable to the average consumer, with a focus on simplicity and clarity to help parents and caregivers make informed decisions.
- Research and Development of Specialized Formula for FPIES
- The NIH shall fund research into the development of specialized formulas for infants and toddlers with FPIES, prioritizing those made from hypoallergenic proteins and formulated for easy digestion, in addition to meeting the nutritional needs of growing children.
- Special attention will be given to formulas that minimize the risk of triggering an FPIES reaction while ensuring proper nutrition.
Section 8: Health Insurance Coverage for FPIES Diagnosis and Treatment
- Comprehensive Insurance Coverage for FPIES
- Health insurance plans, including private insurance and Medicaid, must cover the full costs associated with FPIES diagnosis, treatment, and management, including:
- Diagnostic testing for FPIES, such as stool analysis, endoscopy, and specialized allergy testing.
- Emergency care and hospitalization for severe FPIES reactions, including dehydration, shock, and malnutrition.
- Specialized feeding programs and hypoallergenic formulas.
- Nutritional counseling to support families in choosing safe, allergen-free foods and formula options for children with FPIES.
- Ongoing medical management to monitor and treat long-term effects of FPIES, including growth and development concerns.
- Formula Coverage
- Infant and toddler formula that is medically necessary due to FPIES shall be covered in full under health insurance plans, including the cost of specialized hypoallergenic formulas that are safe for FPIES-affected children.
- Coverage will also include nutritional supplements and consultations with dietitians or pediatricians specializing in food allergies.
Section 9: Vaccine Transparency and Parental Choice
- Vaccine Transparency for Children with FPIES
- Vaccine manufacturers and healthcare providers must disclose information regarding the potential effects of vaccines on individuals with FPIES, including any known interactions between vaccines and food allergies, particularly in infants and toddlers who may have FPIES.
- Healthcare providers should inform parents of children with FPIES about the potential for vaccine ingredients (such as egg protein or other allergens) to trigger an FPIES reaction.
- Informed Consent for Vaccination
- Vaccination shall be voluntary, and parents must be provided with informed consent before vaccination is administered. This consent must include:
- Full transparency about vaccine ingredients.
- Clear documentation of any potential risks for children with FPIES or other medical conditions.
- A discussion of alternative vaccination schedules, if applicable.
- Vaccination Not Mandated in Schools, Sports, or Doctor’s Offices
- Vaccination for school enrollment, participation in sports, and receiving services at healthcare facilities shall not be mandatory. No school, daycare