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Food and Drug Law October 11, 2010. Ralph F. Hall. Overview. Current events Food Dietary supplements Health claims Food summary Drugs History Key concepts Labeling Restricted drugs. Health Claims. Health Claims Background and Policies.

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overview
Overview
  • Current events
  • Food
    • Dietary supplements
    • Health claims
    • Food summary
  • Drugs
    • History
    • Key concepts
    • Labeling
    • Restricted drugs
health claims background and policies
Health ClaimsBackground and Policies
  • Increasing knowledge about food, nutrient and health
    • Old concept – nutrient, taste, aroma
  • Opportunities for abuse
    • Health impacts
      • Actual harm
      • Diversion from therapy
    • Consumer protection
  • Consumer choice
  • Personal freedom
health claims overview
Health ClaimsOverview
  • NLEA – significant scientific agreement
  • DSHEA – supplement related claims
  • FDAMA – authoritative statements
  • Pearson v. Shalala
  • 2003 Guidance (response to Pearson v. Shalala)
    • qualified health claims
    • Less evidence that other bases for health claims
  • Recent litigation
key food statutes
Key Food Statutes
  • 343 (q)
    • Applies to human food
    • Label must include certain information
    • Dietary supplements must have certain nutritional information
  • 343 (r)
    • Deals with health claims and nutrition claims
    • Permits claims is there is an “authoritative statement” from US government (sub G) for certain statements
    • Notice to FDA
    • Health claims require significant scientific agreement
general labeling requirements 343 q
General Labeling Requirements343(q)
  • Basic NLEA information (q)(1) (2)
    • Serving size, nutritional levels, etc.
  • Exceptions (q) (5)
    • Restaurants and retail sales
    • Small business
  • 343 (r)(5) includes other exceptions
nutritional labeling 21 usc 343 r
Nutritional Labeling21 USC § 343 (r)
  • Characterization of food or nutrient value is misbranding unless exception applies
  • Special rules for cholesterol, fat, etc.
  • Multiple ways to make health claims
    • “authoritative statement”
    • Substantial Scientific Agreement
    • Pearson type claim
    • Dietary supplement
nutritional labeling 21 usc 343 r 2 g
Nutritional Labeling21 USC § 343 (r)(2)(G)
  • Health related claims
    • authoritative statement by government entity
      • NAS
      • NIH
      • CDC
    • 120 day prior notification
  • Challenged by regulation, failure to comply with notification requirements, district court action
  • Relationship to DSHEA
authoritative statement national research council
Authoritative StatementNational Research council
  • Authoritative statements “are limited to those that represent the consensus of a duly appointed committee or views of a duly appointed principal investigator so that they appear explicitly as findings, conclusions, or recommendations in a report that has completed the institutional report review process”
    • 1997
nutritional labeling 21 usc 343 r 2 g1
Nutritional Labeling21 USC § 343 (r)(2)(G)
  • Other elements
    • Identical to authoritative statement
    • Agency notification of inadequacy
    • Accuracy (false or misleading?)
    • Comprehension
  • Revocation by regulation (343 (r)(2)(H)
  • See also 21 USC 343 (r) (3) (C)
nutritional labeling 21 usc 343 r 3
Nutritional Labeling21 USC § 343 (r)(3)
  • Health claims based on “significant scientific agreement”
    • Why agreement and what is it?
  • Basis of scientific agreement
    • Qualified experts
    • Compare to GRASE
  • Promulgated by regulation
    • Citizen petitions (21 CFR 10) and (r) (4)
    • Accurate
pearson v shalala 164 f 3d 650 1999
Pearson v. Shalala164 F.3d 650 (1999)
  • Challenge to limitations on health claims
    • limited or inconclusive data to support health claims
    • Involves 4 specific health claims rejected by FDA
  • Dietary supplement provides safe harbor from drug requirements
    • impact of making drug type claims
  • FDA regulated health claims for supplements under DSHEA
  • 1st Amendment challenge
pearson v shalala 1 st amendment
Pearson v. Shalala1st Amendment
  • Central Hudson 4 part analysis
    • Not illegal
    • ,legitimate government interest or policy
    • advances legitimate government interest and
    • least burdensome
  • Government interest
    • protect health
    • prevent fraud
  • Disclosure preferred over suppression
  • Alternative disclosure mandated
    • level of scientific support
  • FDA doesn’t approve use or statements
pearson v shalala fda position
Pearson v. ShalalaFDA Position
  • Health claims are inherently misleading
    • without ‘significant scientific agreement’, statements are inherently misleading
    • Consumers can’t understand labeling with less than conclusive claims
    • FDA position viewed as paternalistic
  • Health claims are potentially misleading
  • Consumers can’t interpret claims
    • no access to data
    • assume FDA agreement with labeling content
  • Disclaimers inadequate
pearson v shalala 1 st amendment1
Pearson v. Shalala1st Amendment
  • Government interests legitimate
    • Policy advances anti-fraud interest
  • Answer is more disclosure, not less
  • Disclosures adequate
  • Need to define ‘significant scientific evidence”
  • Led to 2003 guidance
2003 guidance
2003 Guidance
  • Post Pearson
  • Broader than statute
    • Adds more allowable claims
  • Petition and litigation opportunities
  • Consumer understanding
    • Variable impacts
    • Use of specific language
health claims1
Health Claims
  • Qualifying language used to accurately describe strength of claim
  • Used to allow less proven statements to be made
  • Category A – established claim
  • Category B – “evidence is not conclusive”
  • Category C – “this evidence is limited and not conclusive
  • Category D – “little scientific evidence supporting this claim”
key statutes dietary supplements
Key StatutesDietary Supplements
  • 343 (r) 6
    • Applies to dietary supplements
    • Allows claims with appropriate disclosures
    • Includes statement that FDA has not evaluated claims
    • 30 day notice after 1st marketing
  • 343 (s)
    • Dietary supplements
    • Labeling content
343 r 6
§343(r)(6)
  • Applies to dietary supplements
  • Covered claims
    • Benefit for a “classical nutrient deficiency disease”
    • role of dietary supplement in affecting structure/function
      • Why not a drug?
    • general well being
  • Substantiation that statement is truthful and not misleading
343 r 61
§343(r)(6)
  • Disclaimer regarding FDA approval
    • Required language
  • No intention to diagnose, mitigate, treat, cure or prevent a specific disease
    • Compare to (r)(6)(A)
  • Note structure/function claims v. disease claims
    • What’s the line?
    • “Stimulate, maintain promote” are OK
    • “Restore, correct” are not OK
  • NLEA and DSHEA are separate
  • Post marketing notification
dietary supplements 21 usc 343 s
Dietary Supplements21 USC §343 (s)
  • Specific misbranding section (343 (s))
    • quantity of all ingredients
    • use of term “dietary supplement”
    • must conform to specifications in an official compendium
      • But see Ova II
    • must meet labeled identity, strength, quality or purity
  • Not misbranded because of labeled warning or uses
    • Purpose of this ?
dietary supplement guidance
Dietary Supplement Guidance
  • Extensive comments
    • Notice and comment process
    • Good Guidance Practice
    • 225,000 (many form letters)
  • Purpose of guidance documents
  • How binding
  • Effect of Pearson and Ephedra litigation
    • Are these relevant?
dietary supplement guidance1
Dietary Supplement Guidance
  • Guidelines
    • Provide useful information to consumers
    • Scientifically valid support
    • Do not suggest disease prevention or treatment
    • “Support” or “maintain” statements allowed if
      • don’t suggest prevention or treatment
      • Consumer can evaluate statements
    • Restorative statements questionable when abnormality implies disease
    • Avoid NLEA type health claims
    • Nutritional support claims aren’t drug claims if they avoid reference to specific diseases and don’t make therapeutic promises
dietary supplements 21 usc 343 2
Dietary Supplements21 USC §343-2
  • Labeling exception (343-2)
    • Not misbranding to use books or peer reviewed articles as sales aids
    • not false and misleading
    • Not brand specific
    • not appended to product
  • Addresses Sterling Honey & Vinegar and National Nutritional Foods Assoc.
ephedra
Ephedra
  • Ephedra marketed to enhance athletic performance and weight loss
  • Ephedra linked to heart attack, stroke and increases in blood pressure
  • Dietary supplement can be removed from the market if there is a “significant or unreasonable risk of illness or injury
  • Data required to remove a product from the market
ephedra chronology
Ephedra Chronology
  • Pre 1994 – marketed in US
  • 1994 – FDA medical bulletin warns of ephedra risks
  • 1997 – FDA proposes safety measures
  • 2000 – various public meetings and proposed rules
  • 2/2003 – “FDA acts to reduce safety concerns”
    • public comment
      • safety risks
      • adverse events
    • Record required
    • new warning label
    • warning letters
ephedra chronology1
Ephedra Chronology
  • 2003 Rand Study
    • Risks of Ephedra
  • 7/2003
    • Warning Letters re deceptive claims
  • 12/2003
    • Consumer alert
    • Intent to publish final rule banning ephedra
  • 2/2004
    • FDA issues regulation banning ephedra
    • Consumer advice to not use it
ephedra chronology2
Ephedra Chronology
  • 2005-present
    • Various product seizures and other enforcement actions
    • “Nature’s Treat Energy #1 seized 12/05
  • District court challenge
    • Issue with >10mg levels
    • Adequate administrative record?
    • Burden of proof?
  • Appellate court agrees with FDA
ephedra chronology3
Ephedra Chronology
  • Court of Appeals -10th Cir. (why 10th Cir.?)
  • Upheld FDA
  • Product “adulterated”
    • Illegal to ship in interstate commerce
    • Breadth of coverage
  • Adequate administrative record
  • FDA permitted (or required) to conduct risk/benefit assessment
    • Approval type assessment?
food overview
Food Overview
  • Food – defined by function (321 (f))
  • Food additive – defined by intended use (321 (s))
  • Color Additive – defined by capability and use (321 (t))
  • Dietary supplement – defined by intended use and type of article (321 (ff)
  • Dietary Ingredient – intended use and prior use (350b)
  • Vitamins and minerals – intended use, type of administration and type of article (350)
  • Infant formula – defined by use
food overview1
Food Overview
  • Generally no premarket approval or notification
  • Exceptions for
    • Food additives
    • New dietary ingredients
    • New infant formulas
  • Manufacturing and processing controls
food overview2
Food Overview
  • Food standards
    • Link to misbranding
  • Adulteration
    • Breadth
    • Actual or potential “filth”
    • Economic adulteration
  • Misbranding
    • Term of art
    • False OR misleading
    • Safety and economic protection
  • Labeling requirements
    • Accuracy
    • Quality, quantity, nutritional information, etc.
  • Health claims
purpose of drug provisions
Purpose of Drug Provisions
  • Prevent unsafe or ineffective drugs from being marketed
    • NDA process
    • IND process
  • Protect human rights
    • IND/IRB provisions
  • Get new therapies on the market
  • Require robust manufacturing
    • GMPs
  • Require adequate and truthful information to decision makers
    • Content requirements
    • Promotion restrictions
  • Monitor drug effects
  • Recall or warn HCPs of issues as appropriate
major issues
Major issues
  • Cost of drugs
    • Cost of drug development
  • Lack of innovation
  • R&D spending increasing more than innovation
  • Safety
  • Types of drugs being developed
    • Chronic use
    • Treat, don’t cure
    • Blockbuster
    • “Me-too”
  • Role of industry with FDA
  • Speed of process
  • Generics and biogenerics
  • Post market surveillance
    • Recent product issues and recalls
policy balances
Policy Balances

New therapies

(Faster approvals, less research)

Safety

(More research, slower approval)

Patient Rights

(Access)

Will cost be the 4th factor

drug overview
Drug Overview
  • New concepts
    • Premarket approval required
    • Defined clinical testing process
      • Human subjects protection
      • Good science
    • Greater control over labeling and speech
    • Distribution controls
    • Post market surveillance
    • Defined adverse event reporting system
    • User fees
  • Similar concepts
    • Misbranding
    • Adulteration
    • Prohibited acts
new drug
“New Drug”
  • 321 (p)
  • Types of “newness”
    • New chemical entity (NCE or NME)
    • New combination
    • New indication
    • New dosage, administration, etc.
  • MyKocert
    • What is GRASE
    • Experts in field
    • Some statements that it’s not GRASE
    • High burden for company
    • Deference to agency
process overview
Process Overview
  • Bench testing
  • Preclinical testing
  • Human clinical studies
    • Phase I-III
    • Investigational new Drug Application (IND)
  • New Drug Application (NDA)
    • Risk/benefit approach
    • Labeling (indications, warnings, etc)
  • Post market obligations
    • GMPs
    • Labeling/promotional controls
    • Surveillance and reporting
drug regulatory history
Drug Regulatory History
  • Pre 1906
    • Natural materials
      • Botanicals
      • Minerals and metals
    • “Patent” v. “Ethical” drugs
    • Fraud, safety and efficacy
  • 1906
    • No premarket approval requirements
    • Adulteration and misbranding concepts
    • Post hoc enforcement
drug regulatory history1
Drug Regulatory History
  • 1938
    • Rise of “chemical” based pharmaceutical products
    • Post sulfanilamide
    • premarket approval process
      • GRAS
    • Grandfather “old drugs”
  • 1962
    • Thalidomide
    • Rise of modern pharmaceutical industry
    • GRASE
drug regulatory history2
Drug Regulatory History
  • 1980s
    • AIDS
    • Generics
    • Speed issues
  • 1990s
    • Gene therapy
    • Genetic research
    • Health care cost
    • Role of “Big” pharma
  • 2000s
    • Bioterrorism
    • Individualized therapies
    • Access issues
    • Internet/OUS purchases
drug overview1
Drug Overview
  • Types of “drugs”
    • Pre 1938
    • 1938-1962 (old “new drugs”)
    • “New drugs”
  • Definition of “Drug”
    • Intended use
    • Mode of operation (indirectly)
  • Definition of new drug (§321(p))
    • Post 1938 drug
    • Pre 1938 drug w/ new indication, use, etc
    • Not GRASE
    • Not animal drug
drug adulteration 351
Drug Adulteration§351
  • Traditional food adulteration concepts
    • Filthy
    • insanitary conditions
    • Containers
  • Differs from labeling
    • Content
    • Quality
    • Strength
drug misbranding 352
Drug Misbranding§352
  • Labeling false or misleading “in any particular”
    • 95 Barrels of Apple Cider Vinegar
  • Labeling doesn’t contain required information
    • Manufacturer information
    • Required information
      • Import implications
drug misbranding 3521
Drug Misbranding§352
  • Dangerous when used as labeled
    • Dosage
    • Frequency
    • Manner
  • Registration
  • Listing
  • Uniform labeling symbols
misbranding debates
Misbranding Debates
  • Nue-Ovo
    • Difference of opinion as a defense
    • Expertise of FDA
    • Role of disclaimers under §321 (n)?
  • Control of labeling via approval process
  • Claims of GRASE?
    • What is “generally”
  • Does §352 (j) make sense for post 1962 drugs
drug misbranding 3522
Drug Misbranding§352
  • Adequate directions for use
    • Indications for use
    • “intended use” for definitions
  • Adequate warnings
  • Approval linkage
  • Indication/use approval
    • Not product approval
  • Population indications
    • Pediatric
    • Geriatric
fda enforcement strategy
FDA Enforcement Strategy
  • Priorities
    • Direct (major) health risk
    • Indirect (minor) health risk
    • Major economic fraud
    • Minor economic fraud
  • Linked to prohibited acts
  • Linkage to other health care programs
  • General civil and criminal statutes
label and labeling
Label and Labeling
  • Label - §321 (k)
    • Located on the package
  • Labeling - § 321 (m)
    • Includes “label”
    • Anything that “accompanies the article”
  • § 352 (f)
    • Labeling must include “adequate directions for use”
    • Includes mechanics of use
      • Dose, frequency, etc.
adequate directions for use
Adequate directions for Use
  • Alberty Food
    • Labeling must include purpose or condition for which drug intended
    • Linkage to definition
    • Material shipped separately included if part of an integrated distribution program
    • Adequate directions generally must be on the label
    • “Accompanying” materials can be used to establish intent but more needed for adequate directions
  • FDA label and labeling regulations
    • 21 CFR 201.5
  • FDA squeeze play - §352 (a) or (f)
restricted drugs 353
Restricted Drugs§353
  • Restricted drugs
  • Classification based upon risk, toxicity
  • Safe only if used under physician supervision
    • Risks
    • Addiction
  • Available by prescription
  • Linked to adulteration
  • Label – can only be sold via a prescription