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26/02/2024
Guided by:
Dr. Lokesh Kothari
(M.PHARM Ph.D.)
Medical Food
Sidhant Sanjay Chankeshwara
F.Y M. Pharmacy Drug Regulatory Affairs
MRA 204 T 2nd Semester
Regulatory Aspects of Food & Nutraceuticals
1
Contents
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik)
Introduction
Definition and Purpose of Medical Food
History of Medicinal Foods
Scope of Medical Food in the Nutraceutical Market
Market Trends and Opportunities for Medical Food
Regulatory Considerations for Medical Food
Key Players in the Medical Food Industry
Examples of Medicinal Foods
Benefits and Advantages of Medical Food
Challenges and Limitations of Medical Food
Conclusion and Future Prospects
2
INTRODUCTION
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik)
 Medical food plays a crucial role in addressing specific nutritional
needs for various health conditions. It is specially formulated and
intended for the dietary management of a specific disease or
condition, under the guidance of a healthcare professional.
 Medical foods occupy a unique niche in the realm of nutrition
and healthcare. They are distinct from conventional foods and
pharmaceuticals and are intended to manage specific medical
conditions or diseases for which dietary management is
recognized as an essential component of therapy.
 Understanding the regulatory affairs surrounding medical foods
is crucial for their development, marketing, and distribution.
3
Definition
• A medical food is a specially formulated food that meets
the nutritional requirements of a specific disease.
• According to the U.S. Food and Drug Administration
(FDA), medical foods are formulated for the dietary
management of patients with specific medical conditions
that require distinctive nutritional needs. They are
intended to be consumed or administered orally under the
supervision of a healthcare professional.
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 4
Purpose of Medical Food
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik)
Precise Formulation
Medical food is formulated to provide precise nutrients in specific quantities
to meet the unique nutritional needs of patients with certain medical
conditions.
Disease Management
Healthcare Professional Oversight
It serves as a valuable component of the overall disease management plan
by addressing nutritional deficiencies and supporting improved health
outcomes.
Its usage involves the supervision and guidance of healthcare professionals
to ensure appropriate and effective dietary management.
5
History of Medicinal Foods
• Medical foods were first developed in the 1950s,
originally designed for those with genetic diseases
that could not handle certain nutrients.
• The American Food and Drug Administration (FDA)
originally regulated medical foods as drugs, because
they were intended to affect the structure or function
of the body.
• One of the first medical foods was Lofenalac, an
infant formula produced by Mean Johnson Nutrition
in 1957
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 6
Scope of Medical Food in the
Nutraceutical Market
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik)
Customized Nutritional Solutions Collaboration with Healthcare Providers
Medical food offers the
potential for personalized
nutritional solutions tailored
to specific health conditions
and patient requirements.
It presents opportunities for
collaboration between health
stores and healthcare providers
to offer specialized nutritional
products to patients.
7
Market Trends and Opportunities for
Medical Food
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik)
1 Technological Advancements
Incorporation of advanced technology in the development and
production processes of medical food.
2 Increasing Consumer Awareness
Rising consumer consciousness about the impact of nutrition on
health, driving demand for medical food.
3 Strategic Partnerships
Opportunities for collaborations between food and pharmaceutical
industries, leading to innovative product development.
8
Regulatory Considerations for
Medical Food
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik)
Compliance Requirements
Stringent adherence to regulatory standards and guidelines to ensure safety and
efficacy.
Clinical Validation
Necessity for clinical validation of medical food products to substantiate their intended
medical benefits.
Labelling requirements
The labelling for medical foods must comply with all applicable food Labelling
requirements except for those specific requirements from which medical foods are
exempt. Specifically, the labeling of medical food must contain:A statement of identity
(21 CFR 101.3). An accurate statement of the net quantity of contents (21 CFR
101.105). The name and place of the business of the manufacturer, packer or distributor
(21 CFR 101.5) and Complete list of ingredients, listed by their common or usual name
and in descending order of predominance (21 CFR 101.4). Registration requirements
for medical food facilities. Any facility engaged in manufacturing, processing, packing
or holding medical foods for consumption in the United States must register with FDA. 9
Key Players in the Medical Food
Industry
• Nutricia: Specialize in the delivery of advanced medical
nutrition to all age groups, and are the largest specialist
nutrition company in Europe.
• Nestle: is the largest food and beverage company in the
world, with products sold in more than 130 countries.
Nestle aims to become the world's leader in nutrition,
health and wellness.
• Targeted Medical Pharma: are a small company,
founded in 1999, that develop prescription medical foods
for the treatment of chronic disease, such as pain
syndromes.
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 10
…………….
• Pamlab : are now owned by Nestle Health Science, they
are a biomedical company.
• Abbott Laboratories: are diversified healthcare
company, based in the United States. They have four
core business focuses which include medical
diagnostics, medical devices, nutrition, and
pharmaceuticals.
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 11
Examples of Medicinal Foods
1. Axona (Accera): Axona was developed by Accera as a medical food to
provide the necessary nutrient for patients with Alzheimer’s Disease. AD is
the leading cause of dementia, a neurodegenerative disease characterized by a
decline in the ability of the brain to metabolize glucose, even in it’s early
stages.
2. Lofenalac: Lofenalac was one of the first medical food developed in the late
1950s by Mead Johnson nutrition. It was designated for the dietary
management of phenylketonuria a genetic defection metabolism of
phenylalanine hydroxylase enzyme which converts the amino acid
phenylalanine to tyrosine.
3. Limbrel: Limbrel is a medicinal food developed for the nutritional
management of the metabolic processes associated with osteoarthritis. It was
launched in 2006 by Primus Pharmaceuticals.
4. Deplin: Deplin was developed as a adjunctive therapy to antidepressant drugs
in treating depression by Pamlab Inc.
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 12
Benefits and Advantages of Medical
Food
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 13
1 Precise Nutrient Delivery
Ensures targeted delivery of essential nutrients in forms suitable for
absorption by the body.
2 Clinically Proven Formulations
Formulations tailored based on clinical evidence to address specific
nutritional requirements.
3 Enhanced Therapeutic Outcomes
Contributes to improved health outcomes by addressing nutritional
deficiencies effectively.
Disease Prevention
Certain medicinal foods contain bioactive compounds with
antioxidant, anti-inflammatory, and anti-cancer properties, reducing
the risk of chronic diseases such as heart disease, diabetes, and
cancer..
4
Challenges and Limitations of
Medical Food
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 14
Clinical Awareness
Challenges in raising awareness among clinicians about the
benefits and appropriate use of medical food.
Insurance Coverage
Obstacles related to insurance coverage for medical food
under certain healthcare plans.
Consumer Accessibility
Accessibility issues for patients to obtain prescribed medical
food due to limited distribution channels.
Conclusion and Future Prospects
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 15
Continuous Advancements
Ongoing research and technological advancements
aimed at enhancing the efficacy and availability of
medical food.
Collaborative Initiatives
Potential collaborations between healthcare providers,
researchers, and industry stakeholders to advance the
role of medical food in disease management.
Regulatory Evolution
Anticipation of regulatory enhancements to streamline
the accessibility and utilization of medical food for
patients.
3
2
1
26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 16

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Medical Foods final.ppt (Regulatory Aspects of Food & Nutraceiticals)

  • 1. 26/02/2024 Guided by: Dr. Lokesh Kothari (M.PHARM Ph.D.) Medical Food Sidhant Sanjay Chankeshwara F.Y M. Pharmacy Drug Regulatory Affairs MRA 204 T 2nd Semester Regulatory Aspects of Food & Nutraceuticals 1
  • 2. Contents 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) Introduction Definition and Purpose of Medical Food History of Medicinal Foods Scope of Medical Food in the Nutraceutical Market Market Trends and Opportunities for Medical Food Regulatory Considerations for Medical Food Key Players in the Medical Food Industry Examples of Medicinal Foods Benefits and Advantages of Medical Food Challenges and Limitations of Medical Food Conclusion and Future Prospects 2
  • 3. INTRODUCTION 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik)  Medical food plays a crucial role in addressing specific nutritional needs for various health conditions. It is specially formulated and intended for the dietary management of a specific disease or condition, under the guidance of a healthcare professional.  Medical foods occupy a unique niche in the realm of nutrition and healthcare. They are distinct from conventional foods and pharmaceuticals and are intended to manage specific medical conditions or diseases for which dietary management is recognized as an essential component of therapy.  Understanding the regulatory affairs surrounding medical foods is crucial for their development, marketing, and distribution. 3
  • 4. Definition • A medical food is a specially formulated food that meets the nutritional requirements of a specific disease. • According to the U.S. Food and Drug Administration (FDA), medical foods are formulated for the dietary management of patients with specific medical conditions that require distinctive nutritional needs. They are intended to be consumed or administered orally under the supervision of a healthcare professional. 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 4
  • 5. Purpose of Medical Food 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) Precise Formulation Medical food is formulated to provide precise nutrients in specific quantities to meet the unique nutritional needs of patients with certain medical conditions. Disease Management Healthcare Professional Oversight It serves as a valuable component of the overall disease management plan by addressing nutritional deficiencies and supporting improved health outcomes. Its usage involves the supervision and guidance of healthcare professionals to ensure appropriate and effective dietary management. 5
  • 6. History of Medicinal Foods • Medical foods were first developed in the 1950s, originally designed for those with genetic diseases that could not handle certain nutrients. • The American Food and Drug Administration (FDA) originally regulated medical foods as drugs, because they were intended to affect the structure or function of the body. • One of the first medical foods was Lofenalac, an infant formula produced by Mean Johnson Nutrition in 1957 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 6
  • 7. Scope of Medical Food in the Nutraceutical Market 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) Customized Nutritional Solutions Collaboration with Healthcare Providers Medical food offers the potential for personalized nutritional solutions tailored to specific health conditions and patient requirements. It presents opportunities for collaboration between health stores and healthcare providers to offer specialized nutritional products to patients. 7
  • 8. Market Trends and Opportunities for Medical Food 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 1 Technological Advancements Incorporation of advanced technology in the development and production processes of medical food. 2 Increasing Consumer Awareness Rising consumer consciousness about the impact of nutrition on health, driving demand for medical food. 3 Strategic Partnerships Opportunities for collaborations between food and pharmaceutical industries, leading to innovative product development. 8
  • 9. Regulatory Considerations for Medical Food 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) Compliance Requirements Stringent adherence to regulatory standards and guidelines to ensure safety and efficacy. Clinical Validation Necessity for clinical validation of medical food products to substantiate their intended medical benefits. Labelling requirements The labelling for medical foods must comply with all applicable food Labelling requirements except for those specific requirements from which medical foods are exempt. Specifically, the labeling of medical food must contain:A statement of identity (21 CFR 101.3). An accurate statement of the net quantity of contents (21 CFR 101.105). The name and place of the business of the manufacturer, packer or distributor (21 CFR 101.5) and Complete list of ingredients, listed by their common or usual name and in descending order of predominance (21 CFR 101.4). Registration requirements for medical food facilities. Any facility engaged in manufacturing, processing, packing or holding medical foods for consumption in the United States must register with FDA. 9
  • 10. Key Players in the Medical Food Industry • Nutricia: Specialize in the delivery of advanced medical nutrition to all age groups, and are the largest specialist nutrition company in Europe. • Nestle: is the largest food and beverage company in the world, with products sold in more than 130 countries. Nestle aims to become the world's leader in nutrition, health and wellness. • Targeted Medical Pharma: are a small company, founded in 1999, that develop prescription medical foods for the treatment of chronic disease, such as pain syndromes. 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 10
  • 11. ……………. • Pamlab : are now owned by Nestle Health Science, they are a biomedical company. • Abbott Laboratories: are diversified healthcare company, based in the United States. They have four core business focuses which include medical diagnostics, medical devices, nutrition, and pharmaceuticals. 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 11
  • 12. Examples of Medicinal Foods 1. Axona (Accera): Axona was developed by Accera as a medical food to provide the necessary nutrient for patients with Alzheimer’s Disease. AD is the leading cause of dementia, a neurodegenerative disease characterized by a decline in the ability of the brain to metabolize glucose, even in it’s early stages. 2. Lofenalac: Lofenalac was one of the first medical food developed in the late 1950s by Mead Johnson nutrition. It was designated for the dietary management of phenylketonuria a genetic defection metabolism of phenylalanine hydroxylase enzyme which converts the amino acid phenylalanine to tyrosine. 3. Limbrel: Limbrel is a medicinal food developed for the nutritional management of the metabolic processes associated with osteoarthritis. It was launched in 2006 by Primus Pharmaceuticals. 4. Deplin: Deplin was developed as a adjunctive therapy to antidepressant drugs in treating depression by Pamlab Inc. 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 12
  • 13. Benefits and Advantages of Medical Food 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 13 1 Precise Nutrient Delivery Ensures targeted delivery of essential nutrients in forms suitable for absorption by the body. 2 Clinically Proven Formulations Formulations tailored based on clinical evidence to address specific nutritional requirements. 3 Enhanced Therapeutic Outcomes Contributes to improved health outcomes by addressing nutritional deficiencies effectively. Disease Prevention Certain medicinal foods contain bioactive compounds with antioxidant, anti-inflammatory, and anti-cancer properties, reducing the risk of chronic diseases such as heart disease, diabetes, and cancer.. 4
  • 14. Challenges and Limitations of Medical Food 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 14 Clinical Awareness Challenges in raising awareness among clinicians about the benefits and appropriate use of medical food. Insurance Coverage Obstacles related to insurance coverage for medical food under certain healthcare plans. Consumer Accessibility Accessibility issues for patients to obtain prescribed medical food due to limited distribution channels.
  • 15. Conclusion and Future Prospects 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 15 Continuous Advancements Ongoing research and technological advancements aimed at enhancing the efficacy and availability of medical food. Collaborative Initiatives Potential collaborations between healthcare providers, researchers, and industry stakeholders to advance the role of medical food in disease management. Regulatory Evolution Anticipation of regulatory enhancements to streamline the accessibility and utilization of medical food for patients. 3 2 1
  • 16. 26/02/2024 SNJB's SSDJ College of Pharmacy, Chandwad (Nashik) 16