GRAS: Generally Recognized as Safe food additives
CPSC: Consumer Product Safety Act regulates consumer product or a food, drug, cosmetic.
NLEA: Nutrion Labeling and Education Act of 1990
DSHEA: Dietary Supplement and Health Act of 1994
I. INTRODUCTION
A. History of the Act:
§ 1906 Food and Drug Act
§ 1938 Act required drugs to be approved before put on the market for safety
§ 1962 Act required efficacy
B. Statutory Interpretation
“The most responsive branch of the government is the legislature and their meaning of their words should be given effect by the judiciary”
Legislative History:
§ The paper trace that the legislation provides
o Federal statutes: congressional records, committee reports, bulleted speeches (that were not said on the floor), drafts of bill (most valuable as they were amended and how it changed)
Law of Lenity:
§ Where the intention is not clear from the statute itself and reasonable minds differ about what it really means, the court adopts the less harsh meaning. The court gives the benefit of the doubt to the person charged because they couldn’t have known.
Pragmatist/Dynamic Interpretation
Textualist/Plain meaning
Leading Judge
Posner
Easterbrook
Legislative History
§ What would they have done if they were here now to solve this problem?
§ Is this the best answer?
§ The text is only one legitimate source for intent
§ Suspicious
§ Weakens separation of powers (only the President can veto the language of the bill not the unwritten intentions of its supporters)
§ Asks judges to undertake historical research for which they are ill-suited
§ Empowers judges to enact their own policy choices at the expense of the statutory language
§ Licenses individual legislators and their staffs to make law without obtaining the full support of their colleagues
Legislative Intent
§ Looks for the actual interests at stake, the purposes of the participants, the policies behind the precedents, and the consequences of alternative decisions.
§ Makes room for changing circumstances and changing conceptions of justice to mold the interpretation of statutes, making meaning dynamic rather than static.
§ Incoherent
§ Legislation is a compromise, when the legislature has failed to speak clearly to an issue a court should not try to fill the gap.
§ Courts will only follow plain language
§ Legislators have incentive to draft statutes carefully and precisely
United States v Marshall
Issue:
§ A federal statute stets a five year mandatory sentence for anyone who sells more than one gram of a mixture containing a detectable amount of LSD.
§ Because LSD is sold by the dose the weight has no relevance to the transaction. The effect of the government’s theory is that the seller’s sentence may depend largely on the weight of the medium he chooses.
§ 19,999 pure doses of LSD weigh less than a gram and would escape the statutory minimum; a single does on a sugar cube would carry a mandatory five-year sentence.
Easterbrook:
§ No possible to construe the statute to apply only to the net weight of the drugs.
Posner:
§ Neither the legislative history nor the Justice Department provides any clue into why Congress would want such a bizarre sentencing scheme for LSD.
§ He speculates that Congress probably had no idea how LSD is sold and is essentially willing to nullify the term because he things it renders crazy an otherwise sensible statutory provision.
C. Rulemaking
§ Rule is the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedures, or practice requirements of an agency and includes the approval or prescription for the future rates.
§ It is assumed that agencies have the inherent authority to prescribe rules for the conduct of their own business.
§ But like other agency powers, it must be specifically granted to the agency in the statute that creates the agency.
D. Chevron Doctrine
Determining the issue of congressional intent, if it is unambiguously expressed to the precise question at issue; that is the end of the matter. Look at the legislative history to figure out if the statute on its face is ambiguous. Don’t even look at the legislative history if the words are unambiguous. There is no deference to the agency’s views. There must be no clear intent to withhold jurisdiction or to give jurisdiction.
If it is not clear, the second step is to follow the agency if the statute is silent or ambiguous on that issue.
The question for the court is whether the agency’s answer is a permissible construction of the statute.
It is not up to the court to substitute their meaning if the agency’s construction is reasonable.
II. FOOD
§ A food is a food whether or not you intend it to be a food
§ Food is referred to as common sense food, but also broader.
§ It includes things that you would not think of as food, such as chewing gum and food additives.
§ Restaurant offerings are not under FDA’s jurisdiction.
§ Food allergens must be evident on a label to people. (e.g. yellow #5)
§ Standards of Identity:
o Created by a regulatory process that involves formal hearings.
o Used to deal with economic adulteration questions.
§ If it is a food, it cannot also be a drug based on the structure/function claim for it as a food.
o §321(g)(1)(c): It can be a drug based on this structure/function claim as long as it is not a food.
o This is for food makers to make claims/impart information about how food will affect your body. (American Health Products v Hayes).
Nutrilab, Inc. v Schweiker
Issue:
§ Whether starch blockers are foods or drugs under the FDCA?
Holding:
§ The tablets and pills at issue are not consumed primarily for taste, aroma, or nutritive value under §321(f)(1).
§ They are taken for their ability to block the digestion of food and aid in weight loss.
§ Starch blockers are not chewing gum under §321(f)(2) and are not components of food under §321(f)(3).
§ Starch blockers intend to affect digestion in the people who take them and are drugs under §321(g)(1)(c).
§ The appellate court limited this decision; giving examples such as coffee and prune juice and said it was too restrictive.
III. DRUGS AND DEVICES
Drugs
§ If you propose your product as an alternative to controlled substance, then it is regulated as a drug, since it is a drug claim by definition.
§ Drugs to euthanize animals are within FDA jurisdiction, but those to euthanize humans are not.
§ Controlled substances are within the purview of Drug Enforcement Agency (DEA), and the Controlled Substances Act (CSA).
Devices
§ Class I only subject to general control, if it says it’s sterile it has to be sterile and not causing any bodily harm.
§ Class II subject to special controls
§ Class III devices are subject to pre-market approval and are critical to life.
§ Power to recall medical devices (elsewhere are bargained for recalls and not ordered, except infant formula and human tissue products).
§ Device §201(h):
1. It must be an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory; and
2. It must be recognized in the National Formulary or Untied States Pharmacopoeia, or it must be intended for use in the diagnosis, treatment, or prevention of disease, or it must be intended to affect the structure or function of the body; and
3. It must not achieve its intended purpose through chemical action within or on the body and must not depend on metabolize in order to achieve its intended purposes.
A. Intended Use
National Nutritional Foods Ass’n v Matthews
Issue:
§ Whether the evidence of the extensive use of large doses of Vitamin A and D to treat or prevent diseases and the promotion of such usage by persons not associated with the manufacturers or vendors establishes such widespread therapeutic use at the regulated levels to overcome P’s lack of an intended use to cure or prevent disease and thus justifies the Commissioner’s determination.
Holding:
§ What the company’s stated intent is not dispositive.
§ You can infer manufacturer intent by labeling, etc.
§ The potential for toxicity in issue regulation the court concluded was not relevant to the determination of what the products were or to the manufacture’s intent where you would derive where the products were.
§ Toxicity is not stated in the legislation.
§ You do not differentiate between food and drugs by toxicity.
§ You should not market this product in this way unless it is approved as a drug and rationalize the vitamin the marketplace.
United States v Neptone
Holding:
§ Freeze dried powdered New Zealand green mussel sold in capsule form to prevent various signs of aging is a drug. (ref. 92)
§ In 1983 intention was to market this to diagnose mitigate cure disease, it doesn’t establish this is a drug for all time.
§ They could bring this substance back on the market with different claims in a different niche and they certainly can do that now without question and market it.
Label v Labeling
§ Labeling is broader than label.
§ Label is the label
§ Labeling is the shit you put in the box, or attached to the box.
B. Tobacco Products
§ These are actions in rem, against the thing, are a remedy because of the inefficiency and expense in seizures.
§ First, you find the product.
§ Second, you send out a Federal Marshall with an order of seizure to take custody of it in every federal judicial district.
United States v 46 Cartons…Farifax Cigarettes
Holding:
§ The clear import of the leaflet is at least that the smoking of the cigarettes will make it l less likely that the smoker will contract colds or other virus infections.
§ This is enough o bring the product within the statutory meaning of drug.
Action on Smoking and Health v Harris
Issue:
§ Were the sellers making a drug claim?
Holding:
§ FDA asserted jurisdiction over cigarettes only when health claims were made by the vendors or manufacturers.
Coyne Beahm, Inc. v. US FDA
Holding:
§ “Congress’ use of “can” rather than “will” arguably shows that Congress did not intend for manufacturer representations to provide the only evidence of intended use.
§ Congress has not withheld jurisdiction to regulate tobacco products from the FDA
§ Congress expressed no clear intent in the FDCA to withhold jurisdiction to regulate tobacco products from the FDA
§ The FDA may regulate tobacco products pursuant to the FDCA.
§ Tobacco products fall within the drug and device definitions of the FDCA.
§ Tobacco effects are intended within the meaning of the FDCA: foreseeable use, actual consumer use, statements, knowledge and action of manufacturers.
FDA v Brown & Williamson Tobacco Corporation
Majority:
§ The FDCA does not fit the case of tobacco because the statute requires the FDA to prohibit dangerous drugs or devices like cigarettes outright, and the agency concedes that simply banning the sale of cigarettes is not a proper remedy.
§ Congress has enacted other statutes, which, when viewed in light of the FDA’s long history of denying tobacco-related jurisdiction and considered together with Congress’ failure to explicitly to grant the agency tobacco-specific authority, demonstrate that Congress did not intend for the FDA to exercise jurisdiction over tobacco.
§ No court has found an intended use without manufacturer’s claims; no court has said that you need to solely determine intent by promotional claim.
Dissent:
§ Nicotine affects the structure and function of the body in a manner that is quite similar to the effects of other regulated substances.
§ Addiction, sedation, stimulation, and weight loss are precisely the kind of product effects that the FDA typically reviews and controls.
§ Companies intend their products to affect the body within the meaning of the FDCA.
§ When linguistically permissible, we should interpret the FDCA in light of congress’ overall desire to protect health.
§ Intent is found in consumer use.
Cosmetic Medical Devices
§ Cosmetic medical devices are classified as cosmetics and not medical devices.
§ A product may fall into this category even if it has no medical purpose, so long it is intended to affect the structure or any function of the body. §201(h).
§ Non-corrective decorative contact lenses are cosmetics, but not devices.
Other Issues and Examples in Applying the Device Definition
§ Dual Use Products:
o FDA will regulate a multi-purpose product as a medical device, if it is intended for a medical use.
§ Intended use of a particular product are determined by the labeling, advertising, and other representations accompanying the product.
§ VeriChip, leeches and maggots, sterilizers, and sun-protective clothing are medical devices.
C. First Amendment Limitations
US v 23…Articles
Issue:
§ Whether the libeled “Time to Sleep” records were intended for:
(1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals or
(2) to affect the structure or any function of the body of man or other animals.
Holding:
§ Insomnia is not a disease but is a symptom of a disease and do not fall within the coverage of (1).
§ Sleep is a function of the body, or body and mind, of man and other animals brings the records within the terms of (2) for their intended use was to affect that function.
§ The records are devices within the meaning of
structure/function statement)
3. A statement that characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such a structure or function (also a structure/function statement); or
4. A statement that describes general well-being from consumption of a nutrient or dietary ingredient (a general well being statement)
§ Standard of proof: substantiation that the statement is truthful and not misleading + mandatory disclaimer. ref. 171.
§ Must notify FDA no later than 30 days after the first marketing of the dietary supplement.
C. Nutrient Content Claims
§ (r)(1)(A)
§ (r)(2)(A)(vi) says you can make them in certain circumstances.
o Exemption in statute for claims based on brand names before 1989 (grandfathering)
D. Drug Claims
§ FDA still has pre-market approval authority over certain drug claims.
§ Classified as a drug and will be subject to FDA pre-market approval:
o If a manufacturer makes a claim that a dietary supplement diagnoses, mitigates, treats, cures, or prevents disease the dietary supplement.
§ FDA is precluded from characterizing legitimate structure/function statements and general “well being” statements as drug claims.
NLEA
§ Nutrition Labeling and Education Act 1990 made mandatory nutrition labeling whether or not you made a claim and got standardized.
§ More specific labeling requirements:
o Infant Formula: sole source of nutrition for a group of people.
o Medical food: for people with metabolic diseases
§ Misbranding §343
(1) Serving size, total number of fat, nutrients, etc and regulation over consumer interest items such as trans-fats.
(2) Allows FDA to add or subtract provisions requiring displaying of nutrition information sold in retail in bulk rather than package.
(4) Guidelines, not regulations, on raw agricultural commodities and fish. (USDA governs meat items)
VII. REGULATION OF DRUGS
New Drugs
1. Preclinical phase
a. Purpose:
1. to identify the potetntial effects in the body of the chemical substance being investigated, through laboratory experimentation and animal testing
2. to gather enough evidence on the potential new drug to determine if it is reasonably safe to begin preliminary trials in humans
3. must follow FDA regulations re good laboratory practices (GLPs), but no prior notification requirement
a. GLPs can cover things like:
1. personnel training
2. maintenance of records
3. facilities (suitable size, construction, etc.)
b. Sanctions for violations of GLPs could mean exclusion of the datat gathered at violating facilities
4. unapproved new drugs exempt from interstate comerrce restriction as long as appropriately logged, labeled and maintained.
5. BUT FDA still has discretion to shut down preclinical trial if continued testing would be contrary to the public interest or if it suspects the drugs are being diverted
2. Investigational New Drug Application (IND)
a. application to go into clinical testing phase
b. FDA’s approval focuses on adequacy of testing methods, soundness of data, and safety
1. For safety FDA looks to:
a. pharmacology (what effects the drug actually has in the body)
b. toxicology (how toxic a drug is at various dosage levels)
c. IND must be submitted at least 30 days before sponsor wants to begin trials
3. Clinical Phase
a. purpose is to ascertain safety and efficacy of new drug
b. Much more FDA involvement at this level:
1. to protect the health and safety of human test subjects
2. to ensure the integrity and usefulness of clinical data
c. Phase I
1. administration to small number (20 – 80) of healthy test subjects
a. Phase I generally will not be good enough to establish efficacy
b. BUT in the case of some drugs that are meant for the treatment of serious or life-threatening conditions, patients with the condition may participate in Phase I
1. may establish efficacy
2. purpose is to establish general effects of drug in humans
d. Phase II
1. involves more subjects (maybe up to several hundred) and includes treatment of patients
2. purpose is to establish efficacy
3. at the end of Phase II is when sponsor and FDA will confer re FDA concerns
a. conference optional, but probably a good idea to get a sense of how best to proceed in Phase III
e. Phase III
1. pivotal phase where safety and efficacy established
2. involves more patients (maybe up to several thousand)
3. “multi-center” testing
4. commences with notification to the FDA
5. Throughout, sponsor has certain obligations to test subjects and FDA
a. Ex., if an “adverse event” occurs sponsor must report it to the FDA
1. If the adverse event suggests a significant life-threatening hazard or side-effect not anticipated in the written investigative materials, event has to be reported w/in 15 days
2. If an unexpected life-threatening or fatal event has occurred, sponsor has 7 days to report to the FDA by phone
b. “Clinical holds”
1. maybe issued by FDA for any serious deficiency in an IND or a particular clinical trial
2. FDA must notify the sponsor by phone or other rapid form of communication of the hold and has to send sponsor a written explanation w/in 30 days
3. Until the hold is lifted testing is suspended
4. Sponsor may submit a written request for hold to be lifted
5. FDA has 30 days to respond to such a request
c. IND withdrawal
1. issued for the same reason as holds, but reserved for the most serious cases where continuation of the testing is not warranted by the risks involved
a. may be eligible for reinstatement
2. Where the situation does not present an emergency (where testing would be immediately suspended), FDA will notify the sponsor in writing and allow sponsor 3
