Essential medicines, as defined by the World Health Organization (WHO) are "those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford
Essential medicines, as defined by the World Health Organization (WHO) are "those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford
Nutraceuticals: The Front Line of the Battle for Consumer HealthSemalytix
Nutrition products can be an inexpensive and safe solution to tackle important unmet health needs.
Consumer healthcare has become the battleground where pharmaceutical and consumer goods firms compete for growth. With more people around the world dying from obesity than starvation, poor nutrition is now recognized as a major risk factor for chronic diseases. Most health systems are ill-equipped to deal with this trend.1 Increasingly, patients are being encouraged to take part in their own treatments, and a consumer market has been developing midway between the supermarket-based world of consumer goods companies and the scientific, pharmacy-based world of pharmaceutical firms.2
The front lines of this battle are nutritional products that have been proven to help prevent or cure disease. These "nutraceuticals" present a tantalizing opportunity for breakthroughs to prevent and manage common health problems, offering consumer-focused solutions to issues that are currently addressed only by pharmaceutical interventions—or not at all.3 However, despite being a hot spot for growth, they still suffer from the same challenges as the rest of the sector, with market growth barely keeping up with the rise in gross domestic product.4
In this paper, the third in our Winning the Battle for Consumer Healthcare series, we delve further into the nutraceuticals market to understand the opportunities and barriers to growth. We also look at the successes and challenges faced by both consumer goods and pharmaceutical companies as they struggle to gain the upper hand in this exciting new market.
- See more at: http://www.atkearney.com/paper/-/asset_publisher/dVxv4Hz2h8bS/content/nutraceuticals-the-front-line-of-the-battle-for-consumer-health/10192#sthash.Fx04jdM8.dpuf
Nutraceutical is the hybrid of ‘nutrition’ and ‘pharmaceutical’. Nutraceuticals; in broad, are food or part of food playing a significant role in modifying and maintaining normal physiological function that maintains healthy human beings. The food products used as nutraceuticals can be categorized as dietary fibre, prebiotics, probiotics, polyunsaturated fatty acids, antioxidants and other different types of herbal natural foods. These nutraceuticals used in various diseases such as obesity, cardiovascular diseases, cancer, osteoporosis, arthritis, diabetes, cholesterol, hypertension etc. In whole, ‘nutraceutical’ has lead to the new era of medicine and health, in which the food industry has become a research oriented sector. This article aim to provide the knowledge of nutraceutical with its uses in various diseases.
Guideline của FDA cung cấp câu trả lời về những câu hỏi thường gặp về thực phẩm y tế như: Thực phẩm y tế là gì? Thực phẩm y tế có phải thuốc không? Quy định ghi nhãn như thế nào?
Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn thiết kế GMP EU.
Nutraceutical is the hybrid of ‘nutrition’and ‘pharmaceutical’. Nutraceuticals; in broad, are food or part of food playing a significant role in modifying and maintaining normal physiological function that maintains healthy human beings. The food products used as nutraceuticals can be categorized as dietary fibre, prebiotics, probiotics, polyunsaturated fatty acids, antioxidants and other different types of herbal natural foods. These nutraceuticals used in various diseases such as obesity, cardiovascular diseases, cancer, osteoporosis, arthritis, diabetes, cholesterol, hypertension etc. In whole, ‘nutraceutical’
has lead to the new era of medicine and health, in which the food industry has become a research oriented sector. This article aim to provide the knowledge of nutraceutical with its uses in various diseases.
Nutraceuticals= "Nutrition" and "Pharmaceutical"shhhoaib
Nutraceuticals- As a product isolated or purified from the food generally sold in medicinal form not assisted with food and demonstrated to have a physiological benefit and provide protection against chronic disease.
The detailed presentation on role of Pharmacist in the health care system. It also explain the theme of pharmacy day for 2022.
Its emphasize the there is change in the scope of pharmacist and challenges ahead to meet the society expectation and tells about how to achieve the same.
Nutraceuticals have been gaining importance to combat the associated life style diseases. That's added a new expansion business of the Pharmaceutical Industry.
Systematically developed treatment protocols and prescribing policies designed to assist prescribers/practitioners in making decisions about the appropriate treatment and health care for the specific clinical problem are termed STG (Standard Treatment Guidelines).
Nutraceuticals: The Front Line of the Battle for Consumer HealthSemalytix
Nutrition products can be an inexpensive and safe solution to tackle important unmet health needs.
Consumer healthcare has become the battleground where pharmaceutical and consumer goods firms compete for growth. With more people around the world dying from obesity than starvation, poor nutrition is now recognized as a major risk factor for chronic diseases. Most health systems are ill-equipped to deal with this trend.1 Increasingly, patients are being encouraged to take part in their own treatments, and a consumer market has been developing midway between the supermarket-based world of consumer goods companies and the scientific, pharmacy-based world of pharmaceutical firms.2
The front lines of this battle are nutritional products that have been proven to help prevent or cure disease. These "nutraceuticals" present a tantalizing opportunity for breakthroughs to prevent and manage common health problems, offering consumer-focused solutions to issues that are currently addressed only by pharmaceutical interventions—or not at all.3 However, despite being a hot spot for growth, they still suffer from the same challenges as the rest of the sector, with market growth barely keeping up with the rise in gross domestic product.4
In this paper, the third in our Winning the Battle for Consumer Healthcare series, we delve further into the nutraceuticals market to understand the opportunities and barriers to growth. We also look at the successes and challenges faced by both consumer goods and pharmaceutical companies as they struggle to gain the upper hand in this exciting new market.
- See more at: http://www.atkearney.com/paper/-/asset_publisher/dVxv4Hz2h8bS/content/nutraceuticals-the-front-line-of-the-battle-for-consumer-health/10192#sthash.Fx04jdM8.dpuf
Nutraceutical is the hybrid of ‘nutrition’ and ‘pharmaceutical’. Nutraceuticals; in broad, are food or part of food playing a significant role in modifying and maintaining normal physiological function that maintains healthy human beings. The food products used as nutraceuticals can be categorized as dietary fibre, prebiotics, probiotics, polyunsaturated fatty acids, antioxidants and other different types of herbal natural foods. These nutraceuticals used in various diseases such as obesity, cardiovascular diseases, cancer, osteoporosis, arthritis, diabetes, cholesterol, hypertension etc. In whole, ‘nutraceutical’ has lead to the new era of medicine and health, in which the food industry has become a research oriented sector. This article aim to provide the knowledge of nutraceutical with its uses in various diseases.
Guideline của FDA cung cấp câu trả lời về những câu hỏi thường gặp về thực phẩm y tế như: Thực phẩm y tế là gì? Thực phẩm y tế có phải thuốc không? Quy định ghi nhãn như thế nào?
Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn thiết kế GMP EU.
Nutraceutical is the hybrid of ‘nutrition’and ‘pharmaceutical’. Nutraceuticals; in broad, are food or part of food playing a significant role in modifying and maintaining normal physiological function that maintains healthy human beings. The food products used as nutraceuticals can be categorized as dietary fibre, prebiotics, probiotics, polyunsaturated fatty acids, antioxidants and other different types of herbal natural foods. These nutraceuticals used in various diseases such as obesity, cardiovascular diseases, cancer, osteoporosis, arthritis, diabetes, cholesterol, hypertension etc. In whole, ‘nutraceutical’
has lead to the new era of medicine and health, in which the food industry has become a research oriented sector. This article aim to provide the knowledge of nutraceutical with its uses in various diseases.
Nutraceuticals= "Nutrition" and "Pharmaceutical"shhhoaib
Nutraceuticals- As a product isolated or purified from the food generally sold in medicinal form not assisted with food and demonstrated to have a physiological benefit and provide protection against chronic disease.
The detailed presentation on role of Pharmacist in the health care system. It also explain the theme of pharmacy day for 2022.
Its emphasize the there is change in the scope of pharmacist and challenges ahead to meet the society expectation and tells about how to achieve the same.
Nutraceuticals have been gaining importance to combat the associated life style diseases. That's added a new expansion business of the Pharmaceutical Industry.
Systematically developed treatment protocols and prescribing policies designed to assist prescribers/practitioners in making decisions about the appropriate treatment and health care for the specific clinical problem are termed STG (Standard Treatment Guidelines).
Roti Bank Hyderabad: A Beacon of Hope and NourishmentRoti Bank
One of the top cities of India, Hyderabad is the capital of Telangana and home to some of the biggest companies. But the other aspect of the city is a huge chunk of population that is even deprived of the food and shelter. There are many people in Hyderabad that are not having access to
Key Features of The Italian Restaurants.pdfmenafilo317
Filomena, a renowned Italian restaurant, is renowned for its authentic cuisine, warm environment, and exceptional service. Recognized for its homemade pasta, traditional dishes, and extensive wine selection, we provide a true taste of Italy. Its commitment to quality ingredients and classic recipes has made it a adored dining destination for Italian food enthusiasts.
At Taste Of Middle East, we believe that food is not just about satisfying hunger, it's about experiencing different cultures and traditions. Our restaurant concept is based on selecting famous dishes from Iran, Turkey, Afghanistan, and other Arabic countries to give our customers an authentic taste of the Middle East
Ang Chong Yi Navigating Singaporean Flavors: A Journey from Cultural Heritage...Ang Chong Yi
In the heart of Singapore, where tradition meets modernity, He embarks on a culinary adventure that transcends borders. His mission? Ang Chong Yi Exploring the Cultural Heritage and Identity in Singaporean Cuisine. To explore the rich tapestry of flavours that define Singaporean cuisine while embracing innovative plant-based approaches. Join us as we follow his footsteps through bustling markets, hidden hawker stalls, and vibrant street corners.
Piccola Cucina is regarded as the best restaurant in Brooklyn and as the best Italian restaurant in NYC. We offer authentic Italian cuisine with a Sicilian touch that elevates the entire fine dining experience. We’re the first result when someone searches for where to eat in Brooklyn or the best restaurant near me.
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
