Food and Drug Outline

Adams/Safir

Spring 2013

Introduction
The 1938 FDCA Act gave FDA authority over food, drugs, cosmetics and medical devices
It gained more and gave up some over the years
The Scope of the FDAs power is defined almost entirely by the list of product categories over which it has jurisdiction
Definitions delineate the outer boundaries
Greater authority over drugs, devices, and biological products then over food and cosmetics
Category of the product largely determines regulatory scheme over it
Definitions are broad, confer jurisdiction over a vast range of goods
Sometimes interprets definitions broadly, sometimes narrowly
The FDA as an Agency
25 cents of every consumer dollar regulated by the FDA
Often the focus of intense Congressional and public scrutiny
Budget less than 1 aircraft carrier, including industry user fees
Affects everything you do
Nutrition, safety, availability, information access (many other agencies don't do this), also protection of human subjects
FDA is a part of DHHS
Commissioner is a 3d tier position, requires appt by President and recently requires the approval of Senate
No independent authority to bring suit, goes through DOJ
Science Side of FDA
Center for Food Safety and Applied Nutrition
Center for Drug Evaluation and Research (CDAR)
Center for Devices and Radiological Health (CDRH)
Center for Tobacco
Center for Vet
Enforcement Side
Office of Global Regulatory
Number of district and local offices on the enforcement side
History of the FDA and the FDCA:
Mission of the FDA: science + law enforcement
FDA regulation usually comes from fatal or near fatal events
First regulation came after 11 ppl died in STL, all biological products need to be registered
Then came The Jungle era: food safety became a huge concern-what exactly was going in our processed foods?!
1906 Act: gave the feds the power to proceed against adulterated or misbranded products [CRIMINAL STATUTE]
1938 Act: Alixir came out, an alcohol based solution, created a drug that was essentially antifreeze
90 ppl died in the first month CONGRESS STEPS IN: FDCA (as amended today)
1958: Food Additive Acts
Preservatives, colors, stabilizers, etc
1962 Drug Amendments
Drug developed in Europe that was a "safer" sleeping pill
Only problem was pregnant women that took this pill in first trimester had children born with flippers instead of arms and legs
1976: Now Congress and the FDA turn to devices
FDA started stretching the drugs part of the Act to apply devices
SC agreed with them, Congress stepped in
Hatch-Waxman Act
First amendment that was economic NOT caused by a tragic event
Opened up the pathway for generic drugs to be approved
No reason for generics to have to get approved AGAIN after a patented product lost its patent after 20 years of safety
Led to major litigation because it was so poorly written
1902 Nutritional Labeling and Education Act
Allowing food companies making health claims about food
Created the food labels that we see today
1994 Dietary Supplements Health Education Act
First time that power was taken away from FDA
“Favorite child of the law" you can do and say things with dietary supplements you CANNOT do with drugs
Basic Jurisdiction
Food, Drug, Device
FOOD
Whether a product is a drug or a food often decides the fate of it since drugs are subject to pre-market approval and food is not
Nutrilab Inc v. Schweiker (7th Circ 1983)
Facts: P manufacturers and markets a product known as starch blockers which block the human body's digestion of starch as an aid to controlling weight
Blocker protein is extracted from a certain type of raw kidney bean, FDA classified them as drugs and wants them to be removed from market until FDA approval
H: Language of 321 g 1 c makes the definitions of food and drugs mutually exclusive. Common sense definition of food is whether it is used for TASTE, AROMA, or NUTRITIVE VALUE
Nutritive value is a value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy
Doesn’t matter if its derived from food, what the labeling says, or what the manufacturers intent is since not in food statute.
Starch blockers are drugs under this definition, intended to affect digestion.
***DHEA dramatically altered the categorization for products like starch blockers, now dietary supplements are automatically foods, regardless of whether they pass this test.
American Health Products v. Hayes: Court rejected FDA argument as to dual classification because of parenthetical C in the statute
FDA later said things can be dual classified if it’s a food making therapeutic claims.
Caffeine
Regulated as a drug when it’s a standalone stimulant but not regulated when added to food
Other Food Definitions
Subcategory of Food Additives
Any substance the intended use of which results of may reasonably be expected to result, directly or indirectly, in becoming a component or otherwise affecting the characteristics of any food if such substance is not generally recognized to be safe under the conditions of its use
Some GRAS foods are exempted
Food additives can include migrating substances from the packaging
Chewing gum is a good
Unfit food is still considered a food even if it is unfit for eating by the time FDA institutes legal action.
DRUGS and DEVICES
Drugs
201 g 1 A: USP, National Formulary
201 g 1 B: Articles intended for the use or treatment of disease
201 g 1 C: Intended to change the structure or function of the body
Devices
201 h: Devices-instrument, apparatus, similar, related
h 1: USP
h2: Intended-diseases/conditions
h 3: Intended to change the structure or function of the body
Looks like drug def NOT does not achieve primary purpose through chemical interaction on or within the body
Meant by congress to be a different category of regulation
United States v. An Article of Drug...Bacto-Unidisk (1969)
Issue: scope of the statutory definition of drug in the FDCA and the extent of the Sec's regulatory authority
Facts: Product is an antibiotic sensitivity disc used as a screening test to determine the proper antibiotic to administer
If drug, then needs premarket approval; if device, then only subject to misbranding and adulteration proscriptions; or if no definition, then act doesn't apply
H: Although there is overlap between the definition of device and drug, the natural way to draw the line is in light of the statutory purpose to protect the PH + certify product safety and efficacy
Since the patient will tend to derive less benefit and perhaps some harm if it got the wrong antibiotic, it is entirely reasonable for the Sec to determine that the disks are drugs and subject to preclearance
Inclusion in Official Compendia
Although section 321 g 1 A on its face appears to give FDA the power to treat any item listed in there, it has generally not been read so expansively by the courts
US Pharmacopeia and National Formula is a compendium of standards for drug strength, quality, purity, packaging, labeling, and storage published by USP (NGO)
Homeopathic Pharmacopeia contains many herbal products
An article in USP or NF must meet privately designated standards for quality and strength or otherwise be subjective to misbranding or adulteration action
Recognition of an item in the USP + a label indicating compliance with standards makes a prima facie case that it’s a drug only, adverse party can come forward with contrary evidence
Some item recognized in the USP is not a drug if put into IC without a label such as USP or NF to imply that is intended for medicinal use
US v. Ova II (NJ DC 1975)
H: When considering the regulatory status of a pregnancy test, the official compendia provision of the drug definition cannot be taken literally because literal interpretation would run afoul of the principle that a legislative body many not lawfully delegate its functions to a private citizen or organization
Intended Use and the Food-Drug Spectrum
Most important similarity between the definitions of drug and device is their common reference to "intended use"
FDA Intended Use Definition Since 1952
Refer to the objective intent of the persons legally responsible for the labeling of the drugs
Determined by their expressions or circumstances surrounding distribution of the article
Labeling claims, advertising matter, or oral or written statements by persons or reps
Circumstances that show that with the knowledge of such persons or their reps that the product offered and used for a purpose for which it is neither labels nor advertised
Once they know or should know that it is used for this purpose, then must supply adequate labeling
FDA usually reluctant to attempt to classify a product as a drug or device in the absence of relevant reps from manufacturer or distributor
National Nutritional Foods Assn v. Mathews (2nd Circ 1976)
Facts: Involved high dose vitamin supplements, usually classified as food unless therapeutic claims were made. People were experiencing toxic effects from large doses of Vitamin A and D. FDA came out with regs for these levels of vitamins [later revoked], manufacturers challenged.
H: Vendor's intent in selling the product to the public is the key element in this statutory definition. FDA is not bound by the manufacturer's subjective claims of intent but can find actual therapeutic intent on the basis of objective evidence including labeling, promos, advertising, or ANY RELEVANT SOURCE of if the manufacturer knows or has reason to know that people are using it differently
Toxicity is not included as an element in the stat def of a drug, only relevant to the extent that constitutes objective evidence of therapeutic intent.
In this case, no evidence of intent to market these vitamins at these levels. Mere inclusion in USP or NF is not enough.
I: Since this decision, the FDA has rarely asserted its drug or device jurisdiction over a product without manufacturers reps but still have authority to establish intended use based on circs surrounding the distribution of the article
In 2001 the US brought criminal charges against a number of individuals selling unlabeled balloons containing nitrous oxide outside a rock concert
H: Court said intent for use can be determined by the environment between the buyer and seller
United States v. Articles of Drug...Neptone (DC NDCA 1983)
Facts: Neptone is a freeze dried powdered green mussel, that came with literature in health stores that set it was full of certain elements that made it prevent certain diseases
H: Court said these promotional claims made it a drug, but if they stopped it would be a food again.
Classification of Products as Drugs and Devices and Additional Product Classification Issues (June 2011)
What does FDA Consider in Determining Drug or Device?
Statutory definitions, as as applied to scientific data available to FDA
If you meet def of device, the product also meets definition of drug since drug def scope is bigger
If a product meets both definitions, FDA generally intends to classify product as a device
If the product meets drug definition, but there is uncertainty about whether it meets the device definition also, then FDA generally intends to classify as a drug
How does FDA interpret "similar or related article" in the definition of a device?
Issue is in regards to products in liquid, semi liquid, gel, gas, or powder form; i.e. wound covering gels, gasses used as space filers, etc
Such products may be classified as devices as long as they satisfy the remainder of the device definition, including the chemical action exclusion
How does the FDA interpret "does not achieve its primary intended purposes through chemical action within or on the body of man" in the definition of device?
Even if a product exhibits a chemical action can still meet the exclusion if the chemical action contributes to an effect other than the primary intended purpose of the product
If it has multiple therapeutic effects, each would be a primary intended purpose
Also if it achievesits primary intended purpose through chemical action it still meets the device definition provided that the chemical action does not occur within or on the body of man or other animals
Jurisdiction Issues
Constitutional Limits
United States v. 23...Articles(1951)
Facts: FDA sought seizure and condemnation of certain phonograph records entitled Time to Sleep
H: Obviously records are devices, and were intended for the use in the cure, mitigation, treatment or perhaps prevention of insomnia. Even though experts at trial said insomnia is a symptom not a disease, sleep is a function of the body, and this device is meant to induce sleep so it fulfills the device definition.
United States v. Undetermined Quantities of Article of Device (1982)
Facts: FDA seeking condemnation and forfeiture of 32 self hypnosis tapes, with accompanying literature leaving an impression that the tapes will allow the subconscious mind to bring around the change the person desires using magic. Recently added a "no therapeutic claims" disclaimer to catalogue.
H: The tapes, couple with the literature making therapeutic claims can be condemned. Without the claims, however, the tapes do no more than communicate certain ideas about hypnosis using a tape as toll of communication.
Court also needs to balance philosophical freedom and practical need to protect citizens from hypnosis scams.
Draft Policy Guidance for Regulation of Computer Products (1987)
When a computer product is a component, part, or accessory of a product recognized as a medical device in its own right, the computer component is regulated according to the requirements for the parent device
Those that are not components, but are themselves medical devices are regulated with the least degree of control necessary to provide reasonable assurance of safety and effectiveness
Expert and knowledge based systems are exempt
Updated Policy:
Any software that meets med device definition is a device subject to applicable FDA medical device regulations
Standalone Software and Competent Human Intervention
Standalone medical software is medical software which is neither a component nor an accessory to another device, gets med data as input gives output results to health care user
Previously, "unclassified information management products that were decision support systems intended to involved competent human intervention before any impact on human health occurs" were proposed to be exempted from active regulations
Need for clarification:
Software decision process must be completely clear to the user, with a reasonable opportunity for challenging the results
Must be adequate time available for reflection, ie not in surgery
More complex tech makes it questionable whether a practitioner can reasonably exercise competent human intervention
So now FDA is reexamining criteria for exemption from active regulation
Recall Watson computer software that won Jeopardy
In the past didn't regulate software that had human intervention before any human impact
The more complex the software, the less able the doctor will be to understand or check the algorithm
Even if it’s going to be hard for doc to check, don't want to regulate all software
Key issue is competent human intervention
The Verichip and Letter from Troy:
2002 Letter from FDA to Lawyer for Devices asked whether Verichip, an implantable scannable chip contains medical information, is a medical device
When used as a health information application setting, then it is a medical device
When used for security, financial or personal id or safety then it is not covered by FDCA, even though it is an implant
Thus even if it changes the structure of the body, it is not intended to
Intent based on marketing representation and objective intent of manufacturer
Structure and Function and Intended Use
Intended Use Rule:
Remember the circuits are split on whether you only use manufacturer’s objective intent or consider the circumstances as well
Dual Use Products
FDA has set forth the following policy for products with both medical and non medical uses
Will regulate if intended for medical purpose based on expression of person legally responsible for its labeling and the circs surrounding its distribution
Labeling, ads, and other reps accompanying the product
Products that have med uses only are clearly intended for med purposes and will be regulated as med devices whether or not med claims are made for them
Exercise equipment: Only regulated if therapeutic claims are made from them
Some items clothes have med claims made (ie protects from suns rays etc) so those are med devices
Labeling
Scope of Labeling
Kordel v. United States (1948)
Facts: Kordel was marketing hisown health food products which included literature, some sold with products some displayed in stores where it was sold, some independent of the product, that made statements about efficacy
I: Whether the separate shipment of literature saved the drugs from being misbranded within the meaning of the FDCA
H: If drugs and literature have common origin, were used in the sale of the drugs and explained their uses and were thus interdependent then they are considered labeling
FDCA 201 m 2 doesn't require physical attachment
In another case, leaflets shipped at a different time nonetheless accompanied the device
United States v. 24 Bottles Sterling Vinegar and Honey (2nd Circ 1964)
Facts: A number of books and bottles of V and H were condemned on the grounds that the books were labeling the bottles and were misleading. Balanced Foods sold a book that promoted V and H for a number of medicinal uses, also sold premixed V and H without claims on the bottle.
H: Labels are presented to a customer, in some manner or another, in immediate connection withhis view and purchase of the product.
No evidence that there was joint promotion of the products or that Balanced Foods did more than carry 2 related products.
But see in another case, a book was considered labeling because customer were referred to the book when purchasing a molasses product
DSHEA Rule for Dietary Supplement Labeling:
In order to not be labeling it must:
Not be false and misleading
Cannot promote a particular manufacturer or brand of a dietary supp
Must be delayed or presented with other items on the subject matter for a balanced view
Physically separate from dietary supplements
Many not have appended to it any information by sticker or any other method
Stores usually put these books in their reference section now
Even if you fail to meet all five of these doesn't automatically mean its labeling
United States v.