Gyan Rai, PhD 06/04/2015

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1 * Gyan Rai, PhD 06/04/2015

2 Objectives: 2 1. Current Definition of Probiotics 2. Regulatory Categorization & Intended Uses 3. Probiotics & Medical Foods- How to Fit? 4. Regulatory Implications & Considerations

3 What are Probiotics? 3 Live microorganisms, which, when administered in adequate amounts, confers a health benefit on the host United Nations FAO/WHO Working Group Report; 2002 Report did not consider the following in the scope: Biotherapeutic agents Beneficial microorganisms not used in food GMOs

4 Only Drugs can make Disease Claims : 4 Diagnosis, Cure, Mitigation, Treatment, or Prevention of disease Claims suggesting the product has an effect on a specific disease or class of disease Protective against XXX Protects the development of XXX Reduces the pain and stiffness associated with diarrhea / arthritis Decreases the effects of XXX Alleviates constipation / diarrhea Signs and symptoms of the disease: Improves memory (Alzeimers ) Improves urine flow in men (prostate) Lowers cholesterol (hypercholesterolemia) Reduces joint pain (arthritis) Relieves headaches (migraine)

5 Probiotics as a Dietary Supplement? 5 Unlike Drugs or Biologics: Do not require pre-market FDA approval Safety, purity, potency, and efficacy need not be established Burden is generally on FDA to prove supplement is unsafe Can make structure/function claims if: Truthful & not misleading Handout articles without referencing product Must be submitted to FDA within 30 days of marketing Must carry FDA disclaimer Containing one or more dietary ingredient : Vitamin Mineral Herb/botanical Amino acid Dietary substance to supplement the diet by increasing total dietary intake Concentrate, metabolite, etc. of any of the above Intended for ingestion; and Not represented as a conventional food or as a sole item of meal/diet (i.e. intended to supplement the diet) (21 U.S.C. 321(ff))

6 What is Medical Food? 6 Food which is formulated to be consumed or administered enterally (through GI tract, whether orally or by tube) under a physician s supervision and which is intended for specific dietary management of a disease or condition for which distinctive nutritional requirements (based on recognized scientific principles) are established by medical evaluation (21 U.S.C. 360ee(b)(3))

7 Types of Medical Food Claims: 7 Examples: Nutrient deficiency: Provides vitamin C and to prevent scurvy (allowed if relevant to the United States population) Nutritionally complete formula to support malnutrition in GI compromised patients A phenylalanine-free food for the nutritional management of hyperphenylalaninemia A nutritionally complete formula providing concentrated source of calories for patients with restricted fluid intake or increased metabolic needs such as oncology patients, hypermetabolic conditions, trauma, sepsis, and post surgery

8 Claim Substantiation of Medical Foods: 8 No specific medical food regulations for clinical substantiation of claims The need for a strong standard of scientific evidence for the composition and effectiveness of medical foods The scientific standard contained in the statutory medical food definition may require some of the same types of data for medical foods as are needed to support drug claims (e.g., data from clinical investigations) FDA proposed to evaluate its medical foods oversight Safety information about the ingredient/product should be widely available (61 Fed. Reg (November 29, 1996))

9 Criteria for Medical Foods: 9 Specially formulated and processed for partial or exclusive feeding of patient orally or by enteral tube; and Intended for use only under medical supervision; and Intended only for patient receiving active/ongoing medical treatment; and Intended for dietary management of a patient which cannot be achieved by the modification of the normal diet (e.g., chronic medical needs; limited/impaired capacity to ingest, digest, etc.; other special medically-determined nutrient needs); and Provides nutritional support to manage the distinct nutritional requirements resulting from a specific disease/condition (21 C.F.R (j)(8)

10 10 The Year 2013:

11 The IRB Guidance: Why is it Important? 11 According to the FDA, Food use is primarily for its taste, aroma, or nutritive value Biological Endpoints require IND: Sections VI.C. & VI.D. extend the existing IND requirements to any clinical research measuring drug/biologic (disease) endpoints that involves any articles of food, dietary supplement, and cosmetics Forces IRB to opt for an IND Essentially bans responsible clinical research in the absence of an IND for articles that are not drugs or new drugs

12 12 Biological end point of a drug v/s food : why claims matter? FDA strictly interprets: intent to study element of clinical study is synonymous to the intended use element of product An Unapproved Drug: A product marketed or promoted as a treatment, prevention or cure for a disease or condition without an approved indication for such, is considered an unapproved and therefore, an illegal drug Biological end points: Blood Pressure Pulse wave velocity Hyperimic blood flow Perfusion RBC deformability HbA1c levels Serum albumin Blood cholesterol Blood lipid

13 IND Guidance: Legal & Regulatory Framework 13 Sec Requirement for an IND: (a) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigation with an investigational new drug that is subject to 312.2(a) (b) A sponsor shall not begin a clinical investigation subject to 312.2(a) until the investigation is subject to an IND which is in effect in accordance with

14 OK- I will file an IND.but wait 14 Prohibits the interstate shipment of certain foods to which: An approved drug or a licensed biological product, has been added A drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public, has been added Sec. 301(II) of FDCA

15 FSDU & Medical Foods 15 FSDU is a Conventional Food ; BUT Intended to meet special nutritional needs associated with age, physiological conditions, or disease. Useful in supplying special dietary needs for patient prevented from eating normally, BUT medical supervision not required NOT specifically tailored for distinct nutritional requirements of the patient s disease/condition/treatment

16 Strict FDA Interpretations: 16 FDA interprets the Medical Foods definition more narrowly: To limit foods that make unapproved disease claims Apply to those that appear to provide proven, essential therapies FDA has attempted to further narrow medical food category: Advance Notice of Proposed Rulemaking-1996 (withdrawn 2003) Medical Food FAQs; Draft Guidance IND guidance document- 2013

17 Let s try to Apply the MF criteria to Probiotics: 17 Specially formulated and processed for partial or exclusive feeding of patient orally or by enteral tube; and Intended for use only under medical supervision; and Intended only for patient receiving active/ongoing medical treatment; and Intended for dietary management of a patient which cannot be achieved by modification of the normal diet (e.g., chronic medical needs; limited/impaired capacity to ingest, digest, etc.; other special medicallydetermined nutrient needs); and Provides nutritional support to manage the unique nutrient needs resulting from a specific disease/condition (per medical evaluation)

18 Evidence Requirements Specific to Probiotics: 18 Safety of the ingredient- Reasonable certainty of no harm: GRAS or Food Additive Notification Usage & Claim: Probiotics as an ingredient/component of a Food, FSDU, or a MF Probiotics as MF- Generate Scientific Knowledge: Demonstrate unique nutrient requirements How is it unique to the product? Can it be achieved by modification of the diet? For the (nutritional) management of a disease/condition? Work with the agency and develop an understanding about: The quality of evidence and the relationship with the nutritional management of the disease/condition Understand the current framework and the existing criteria for MF

19 Probiotics & the Distinct Nutritional Requirement: 19 Specially formulated and processed for partial or exclusive feeding of patient orally or by enteral tube; and Intended for use only under medical supervision; and Intended only for patient receiving active/ongoing medical supervision; and Intended for dietary management of a patient which cannot be achieved by the modification of the normal diet alone (e.g., chronic medical needs; limited/impaired capacity to ingest, digest, etc.; other special medically-determined nutrient needs); and Provides nutritional support to manage the distinct nutritional requirements resulting from a specific disease/condition (21 C.F.R (j)(8)

20 What else can we do? 20 Dialog with the agency for the role of nutrition in health and disease Relying on data to overcome barriers to narrow interpretations of health claims for all food categories, including MFs Encourage & work with the FDA in the development of evidence standard for disease claims for foods and not drugs Encourage & work with the FDA to incorporate & evaluate the developing science Influence product categorization to match the level of evidence for nutrition

The Path to U.S. Market for Functional Food Ingredients

The Path to U.S. Market for Functional Food Ingredients American College of Nutrition Symposium Morristown, New Jersey November 18, 2011 DIANE B. McCOLL Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street,