FSSAI guidelines (AHFAZ) related to nutraceuticals and functional herbs

The ppt is about the FSSAI guidelines related to nutraceuticals and functional herbs

1. FSSAI GUIDELINES FOR NUTRACEUTICALS & Herbs as a functional food GUIDED BY- Miss Ifra Naaz  Dept of pharmacognosy and phytochemistry GCOP Amravati PRESENTED BY- Mohammad Ahfaz Zaid  M.pharm 1st year Dept of pharmacognosy and phytochemistry GCOP Amravati Seminar on GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI

2. CONTENT GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 1 )FSSAI Guidelines for                                                       1 Nutraceuticals   2)Registration and licensing Requirements.                    10 3)Process of Registration of                                              16 Dietary supplement in US 4) Herbs as a Functional food.                                          19 5)Regulatory status.                                                            22

3. FSSAI GUIDELINES FOR NUTRACEUTICALS 

4. 1)FSSAI GUIDELINES FOR NUTRACEUTICALS  According to the Food Safety and Standards Authority of India (FSSAI), a nutraceutical is a food product that provides physiological benefit and helps maintain good health . In 2006 parliament passed ,food safety and security ACT. Then in 2008, FSSAI came into existence. For implementation of FSSAI Act process of pre publication  That handled food related issues in various Departments. • The FSSAI is responsible for setting standards for food so that there is one body to deal with and no confusion in the minds of consumers, traders, manufacturers, and investors.  GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 1

5. GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 2

6. The FSS Act The FSS Act took 8 older acts into one umbrella.   Prevention of Food Adulteration Act, 1954 Food Law   Fruit Products Order, 1955   Meat Food Products Order, 1973   Vegetable Oil Products (Control) Order, 1947   Edible Oils Packaging (Regulation) Order 1988   Solvent Extracted Oil, De- Oiled Meal and Edible Flour (Control) Order, 1967   Milk and Milk Products Order, 1992   The FSS Act is a bucket for all the older laws, rules and regulations for food safety GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 3

7. FSSAI -Administrative structure  • Ministry of Health & Family Welfare, Government of India is the Administrative Ministry of Food Safety and Standards Authority of India. • The FSSAI is headed by a non-executive Chairperson, appointed by the Central Government, either holding or has held the position of not below the rank of Secretary to the Government of India. • The FSSAI consists of a chairperson & 22 members. •Ashish Bahuguna is the current Chairperson for FSSAI and Pawan kumar Agarwal is the current Chief Executive Officer for FSSAI. members GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 4

8. Location FSSAI is located in 5 regions   Northern Region — With head office at New   Delhi   Eastern Region- Kolkata   North Eastern Region- Guwahati   Western region- Mumbai   Southern Region- Cochin and Chennai GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 5

9. GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 6

10. functions GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 7

11. Standards › Dairy products and analogues   Fats, oils and fat emulsions   Fruits and vegetable products   Cereal and cereal products   Meat and meat products   Fish and fish products > Sweets & confectionery   Sweetening agents including honey   Salt, spices, condiments and related products > Beverages, (other than dairy and fruits & vegetables based) • Other food product and ingredients   Proprietary food   Irradiation of food GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 8

12. Food products with FSSAI mark  GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 9

13. 2)REGISTRATION AND LICENSING REQUIREMENTS FSSAI License or registration is based on the premises and volume of the business. Depending upon the turnover, location, the capacity of the business, the applicant can get the license in different ways as mentioned below: Basic FSSAI Registration This is for the entity whose turnover does not increase 12 lakhs per annum. Hawkers and vendors come under this category. FSSAI State License This is for the entity whose turnover is not less than 12 lakhs and not more than 20 crores annually. Central FSSAI License This is for the entity whose turnover is more than 20 crores for producing, trading or storing the food products up to a specific limit prescribed by the law. GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 10

14. Applicable FSSAI License FSSAI issues three types of license based on nature of food business and turnover:    Registration: For Turnover less than 12 Lakh    State License: For Turnover between 12 Lakh to 20 Crore    Central License: For Turnover above 20 Crore GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 11

15. GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 12

16. Who Requires FSSAI Registration In India? Hotels and restaurants. Wholesaler. Dairy Shops. Food importers and food exporters. Suppliers of raw materials. Retailers who have a retail outlet. Transporters. Canteens or pantry in colleges, schools, corporations, government schools, and hospitals. Packaged food manufacturers. Processors such as dry fruit and pickle maker. Food chains. GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 13

17. Process Of FSSAI Registration In India Step 1 First, submit the application form (Form A) to the Food and Safety Department. Step 2 Within 7 days, the application made by the applicant can be accepted or rejected by the Food and Safety Department [1] . Step 3 If the Department accepts the application, then they will issue a registration certificate along with the registration certificate number and applicant’s photo. Step 4 During the working hours, FBO should display the registration certificate at the place of business. GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 14

18. Fees Associated With The Registration For FSSAI License In India GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 15

19. 3)PROCESS OF REGISTRATION OF DIETARY SUPPLEMENTS IN US Registering a dietary supplement in the United States involves several steps to comply with regulations set by the Food and Drug Administration (FDA): GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 16

20. 1.Product Development and Formulation:       Create the supplement formulation and ensure it meets FDA regulations regarding ingredients, dosage, and safety. 2 . Labelling Compliance:   Design labels following FDA guidelines, including accurate ingredient listings, nutritional information, and any necessary disclaimers or warnings. 3.New Dietary Ingredient (NDI) Notification:  If the supplement contains a new ingredient , a pre-market notification to the FDA (NDI Notification) is necessary to establish the ingredient’s safety. 4. Facility Registration:  Register the manufacturing facility with the FDA as required by the Dietary Supplement Current Good Manufacturing Practices (cGMPs). GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 17

21. 5. FDA Review: The FDA reviews the submitted information to ensure compliance with regulations. If everything meets the requirements, the FDA assigns a registration number, allowing the product to be marketed in the US. 6Market the Supplement: Once approved, the dietary supplement can be marketed and sold in the US, following all FDA regulations regarding advertising and distribution. GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 18

22. Herbs as functional food

23. 4)Herbs as a functional food Herbs can indeed be considered functional foods due to their potential health benefits beyond basic nutrition. Many herbs contain bioactive compounds such as antioxidants, vitamins, and minerals that can positively impact health. For instance, herbs like turmeric, ginger, and garlic have been studied for their anti-inflammatory, immune-boosting, and antioxidant properties, showcasing their functional roles in promoting well-being and potentially reducing the risk of certain diseases. Incorporating various herbs into one’s diet can contribute to overall health and support specific bodily functions. There is wide variation in the level of research available to support claims for nany herbal supplements.  . When herbal compounds have been tested in clinical trials, it is usually as a standardized extract, or specific supplement, rather than as part of the food. GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 19

24. What are Functional Food "Functional Food is a Natural or processed food that contains known biologically-active compounds which when in defined quantitative and qualitative amounts provides a clinically proven and documented health benefit, and thus, an important source in the prevention and management of chronic diseases of the modern age". These foods are not intended only to satisfy hunger and provide humans with necessary nutrients, but also to support prevention of nutrition-related diseases and increase physical and mental well-being of consumers. For e.g.- DHA/ EPA, Isoflavones, FructoOligosaccharides, etc.   For e.g. phytoesterols to reduce cholesterol prebiotic for better gut function GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 20

25. GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 21

26. 5)Regulatory Status  As mentioned previously, no separate regulatory category exists for functional foods. As such, regulations for conventional foods applied. To be used in a food, an herbal ingredient must be (GRAS) or approved as a food additive. GRAS stands for “Generally Recognized As Safe,” a designation by the U.S. Food and Drug Administration (FDA) for substances added to food that are considered safe by experts based on a long history of common use in food or through scientific evidence. GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 22

27. GRAS APPROVAL  PROSCESS The Generally Recognized as Safe (GRAS) process involves assessing substances to determine their safety when used in food. There are two main pathways for obtaining GRAS status: 1.Expert Panel Review:   A company can assemble a panel of experts qualified by scientific training and experience to evaluate the safety of the substance. 2.FDA Review:  Companies can submit a GRAS notification to the FDA. This notification includes detailed scientific data and information demonstrating the safety of the substance for its intended use. GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 23

28. Key steps in the GRAS process include: •Literature Review:  A comprehensive review of available scientific literature related to the substance’s safety. •Toxicological Studies:  Conducting studies to assess potential adverse effects of the substance. •Expert Panel Evaluation:  An expert panel assesses the safety data and reaches a conclusion based on their expertise. •Documentation:  Preparation of a detailed report summarizing the data, analyses, and conclusions supporting the safety of the substance for its intended use in food. GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 24

29. EXAMPLE OF HERBS AS FUNCTIONAL FOOD Garlic plant• Garlic, Allium sativum, is a root crop (meaning the bulb grows underground) of the family Alliaceae• It is among the oldest of all cultivated plants; in facts, its species name, sativum, means cultivated Ginkgo• Ginkgo is a genus of highly unusual non-flowering plants.• Ginkgo biloba• also known as the maidenhair tree• Native to China, the tree is widely cultivated and was introduced early to human history. BY GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 25

30. Ginseng Comes from the family Araliacéae • Angiosperm• 13 species of Panax are considered to be ginseng• Considered to be a cure-all• Found in Asia and North America• wo important species: P. ginseng (Asian) and P. quinquetolius  (American) GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 26

31. References 1.Advanced pharmacognosy-1 by pv books,authors Dr. Deenanath JhadeDr . Neeraj Kumar SharmaDr . Mona KejariwalDr . Md. Rageeb  Md. Usman 2.Ppt by hexangon nutrition, 3. MINISTRY OF HEALTH AND FAMILY WELFARE(FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA)NOTIFICATIO 23rd December , 2016 4.corbiz.com . GOVERNMENT COLLEGE OF PHARMACY, AMRAVATI 28

32. [email protected] Thank you