Getting Your Ingredient to Market: Understanding Your Regulatory Options Venable LLP

Transcription

1 Getting Your Ingredient to Market: Understanding Your Regulatory Options 2013 Venable LLP 1

2 Overview of the Governing Laws 1. The Federal Food, Drug, and Cosmetic Act ("FD&C Act"): Requires foods, cosmetics, dietary supplements, drugs, and medical devices to be safe. The Act also requires that product labeling be truthful and non-misleading 2. The Federal Trade Commission Act: Requires all advertisements to be truthful and nonmisleading 3. The Fair Packaging and Labeling Act ( FPLA ): The FPLA sets the specific requirements for the labeling of all consumer commodities Subjects to be covered 2

3 Overview of the Governing Laws 4. The Lanham Act: Provides a basis for competitors to challenge product claims 5. State Laws: For example California Proposition 65 and mini-ftc laws 3

4 Governing Agencies 1. The Food and Drug Administration (FDA): The Agency with the primary responsibility for ensuring the safety of foods, cosmetics, dietary supplements, drugs, and medical devices. Also, sets labeling requirements for these products 2. The Federal Trade Commission (FTC): The FTC has authority over product advertising. The FTC may challenge an advertisement on the following grounds: False or deceptive Likely to mislead reasonable consumers Likely to influence consumer purchasing decisions or otherwise affect important consumer decisions 4

5 Governing Agencies 3. Various State Agencies: The individual states also have various consumer agencies to enforce state consumer laws 5

6 GRAS Intended to become component of or affect characteristics of food Food Your Product Consumed for taste, aroma, nutritive value Food Additive Intended to become component of or affect characteristics of food Intended to supplement diet Dietary Supplement Intended to diagnose, cure, mitigate or treat disease Drug 6

7 Regulatory Approaches for Getting to Market Ingredient Drug Approval Process Long Process Expensive Exclusivity Available Disease Treatment Claims Dietary Supplement Least expensive route to market 75-day notification process for new dietary ingredients/otherwise straight to market No exclusivity outside patent Structure/function and health claims Food Additive Long/expensive process No exclusivity outside patent Structure/function and health claims GRAS FDA Submission Voluntary Shorter/less expensive process No exclusivity outside patent Structure/function and health claims 7

8 Food Additive Definition: Any substance, the intended use of which may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food Exclusions: dietary ingredients in dietary supplements, pesticides in or on raw agricultural commodities, color additives, prior sanctioned substances, substances that are GRAS Regulatory Approval: Premarket FDA approval Long process that could take years 8

9 GRAS Ingredients Definition: General recognition of safety by experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food Basis may be either scientific procedures or common use in food prior to January 1, 1958 Regulatory Approval: Not required. As a practical matter, many customers may want you to submit a GRAS notification to FDA before incorporating the ingredient into their products GRAS notification shorter process than food additive generally less than 1 year 9

10 Dietary Supplement Definition: A product intended to supplement the diet Contains one of the following dietary ingredients: Vitamins, Herbs/Botanicals, Minerals, Amino Acids, A substance used to increase total dietary intake A concentrate, constituent, extract or combination of the above An approved drug if previously used as a supplement Must NOT be represented as a conventional food Must NOT be represented as a sole item of a diet Must be labeled dietary supplement Must NOT present a significant or unreasonable risk of harm Regulatory Approval: Not required. 10

11 Dietary Ingredients in Dietary Supplements Definition: Ingredients OK if marketed prior to October 1994, if no significant risk or unreasonable risk of injury or illness If not marked prior to October 1994, and not present in the food supply (not chemically altered), then via a new dietary ingredient (NDI) notification: Provide reasonable assurance that no significant or unreasonable risk of injury will occur 75-day FDA pre-market notification 11

12 Permissible Marketing Claims for Foods and Dietary Supplements Overall health and well-being claims Structure/function claims Health claims, qualified and unqualified Nutrient content claims 12

13 Structure/Function Claims Describe the effect a particular dietary supplement or nutrient has on the structure or function of the body Structure/function claims, however, cannot suggest that the supplement is useful in the diagnosis, cure, treatment, prevention or mitigation of a disease or health-related condition. The more closely a particular structure/function claim is connected to a particular disease condition, the less likely FDA will consider the claim to be a permissible structure/function claim 13

14 Examples of Permissible and Impermissible Structure/Function Claims Examples of claims that do not violate this criterion are: Helps alleviate the occasional blue feeling everyone experiences from time to time Helps maintain joint health and flexibility Helps maintain a healthy heart Examples of impermissible claims under this criterion are: Helps alleviate the blues associated with emotional despair (i.e., despair=depression) Reduces the pain and stiffness associated with arthritis Helps alleviate the pain associated with migraine headaches 14

15 Health Claims Defines the relationship between a nutrient, food, or dietary supplement and a reduction of risk in a certain disease Must submit a health claim petition or authoritative statement notification to FDA and FDA must authorize the use of the claim Once authorized, it may be used by everyone in the market place Potentially a great licensing opportunity All health claims qualified or unqualified must be used verbatim 15

16 Disease or Drug Claims The FDA does not permit the use of disease or drug claims on the label of dietary supplements unless they are permitted health claims. FDA defines disease as follows: A disease is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g. hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition. 16

17 Drug Definition Product intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans Prescription Drug Required to be taken under the care of a physician OTC Drug Capable of self diagnosis and disease or symptom is of a short duration. Must be in the OTC monograph or received regulatory approval New Drug Application ( NDA ) or Abbreviated New Drug Application ( ANDA ) Monograph Ingredient Claims: Drug claims Regulatory Approval: Pre-market FDA Approval 17

18 Drug Flow Chart Bioactive Product What is the intended use? Used to diagnose, cure mitigate, treat or prevent disease Ingested to affect structure or function of body Drug Yes Intended for use as a drug under 21 U.S.C. 321(g)? Yes Is the proposed indication appropriate for nonprescription use? No Has it been marketed in the U.S. for a specific OTC indication for a material time and to a material extent? No Yes Does available evidence of safety and effectiveness warrant inclusion of an OTC monograph? No Yes Is there sufficient evidence of safety and effectiveness and adequate CMC information to support NDA? Yes Is marketing exclusivity desired? Yes No OTC Monograph No NDA application IND 18

19 Issues with Foreign Research Differences between populations, such as differences in diet, general health, or patterns of use, could confound results Ensure ingredient is same language/dialect could cause same name to apply to two different substances. For all ingredients, testing and purity needs to meet U.S. standards 19

20 Drug vs. Food or Dietary Supplement Pro s of marketing drugs that have gone through FDA s approval process: Make express disease claims Exclusivity during initial marketing phase regardless of patent consideration Higher price point Prescription drugs covered by insurance plans 20

21 Drug vs. Food or Dietary Supplement Pro s of marketing an ingredient as a food or dietary supplement: Lower barrier to market entry U.S. consumers understand the implied meaning of structure/function claims Less costly to manufacture Less regulatory oversight 21

22 Drug vs. Food or Dietary Supplement Con s of marketing drugs that have gone through FDA s approval process: Extensive amount of R&D time Drug approval process takes years Costs will most likely be in the tens of millions if not higher No guarantee of approval Significant regulatory oversight 22

23 Drug vs. Food or Dietary Supplement Con s of marketing an ingredient as a food or dietary supplement: Limited to structure/function claims or FDA authorized health claims Generally not covered by insurance Generally no barriers to entry by competitors 23

24 Product Liability Costs can be significant Verdicts can be $100 million and up (e.g. 1 Vioxx case alone awarded plaintiff over $250 million) FDA approval is NOT a defense Product liability insurance carriers have their own exclusion criteria (e.g. Ephedra and L- tryptophan) 24

25 Contact Information Todd A. Harrison, Partner t f Michelle C. Jackson, Counsel mcjackson@venable.com t f Claudia A. Lewis, Partner calewis@venable.com t f Heili Kim, Counsel hkim@venable.com t f John G. Moore, Counsel jgmoore@venable.com t f

26 the road ahead for ABC CORPORATION Venable LLP