Defining and Distinguishing Drugs from Foods, Dietary Supplements, Devices and Cosmetics

unqualified health claims

authorized pursuant to the "significant scientific agreement" standard

PPPA

has to be packaged in a way where the consumer can see whether tampering has occurred or not

when can a cosmetic become a drug?

if its manufacturer promotes it for a therapeutic purpose, despite the product chemistry

do cosmetics have structure/function claim exemptions?

no, so if a cosmetic has a structure function claim, it WILL be regulated as a drug which means premarket approval is required

fda modernization act of 1997

permitted health claims without the requirement that the fda must issue a regulation as long as there is "significant scientific agreement" as determined by the fda

acceptable/unacceptable: cranberry tablets prevent urinary tract infections

unacceptable, prevent = issue

acceptable/unacceptable: product prevents diarrhea associated with abx use

unacceptable; prevents is an issue and diarrhea from abx use implies c. diff = no no

acceptable/unacceptable: product maintains healthy intestinal flora

acceptable

food - federal definition

articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article

health claims and DS

- 2 essential components: a substance (whether a food, food component or ds), and a disease or health-related condition - ex: acceptable: "adequate calcium throughout life may reduce the risk of osteoporosis" unacceptable: "adequate calcium throughout life may prevent osteoporosis"

DS defined

- a product that is intended for ingestion, is intended to supplement the digest, and contains any one or more of the following: a vitamin, mineral, herb/other botanical, an amino acid, a dietary substance for use by humans to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of the previous listed items - fda list of illegal ingredients in ds

cosmetic - federal definition

- article intended to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the human body for the purpose of cleansing, beautifying, promoting attractiveness, or altering the appearance - any component of the above articles is considered a. cosmetic - soap is not a cosmetic

medical device amendment act of 1976

- authorized fda to regulate medical devices - differentiates devices from drugs by defining a device as a product that does not achieve any of its principal intended purposes through chemical action and is not dependent on being metabolized for the achievement of any of its principal intended purposes

manufacturer's claims for ds

- cannot make part b claims - DS may make any of the following types of claims: health claims (describe relationship bt product and reducing the risk of a disease-related condition) nutrient content claims (describe the relative amount of a nutrient in a product) structure/function claims (do not require fda approval but there is guidance and disclaimers that have to be made) - describe how a product may affect the organs or systems of the body but cannot mention specific dz general wellbeing claims claims related to a nutrient deficiency disease

medical devices class II

- general controls are insufficient to ensure safety and effectiveness an are subject to special controls (performance standards, postmarket surveillance, pt registries, development and dissemination of guidance documents, recommendations, and other appropriate actions) - these devices must meet specific performance standards established by the fda - ex: insulin syringes, infusion pumps, thermometers, diagnostic reagents, tampons and electric heating pads

what questions do you ask when a drug is used as a device?

- is the product intended to deliver drugs to the pt, but is not prefilled by the manufacturer? (ex: syringe) - is the drug component included solely to make the product safer? - is the drug component intended to have a therapeutic effect? can be both

labeling requirements for cosmetics

- list ingredients in descending order of predominance - "fragrances" or "flavors" listed generally warning labels - self pressurized containers - if safety has not been determined, must warn - hair dyes with coal tar

qualified health claims

- may be made when the claim does not meet the significant scientific agreement standard and when the claim would be misleading without the qualification - allowed when there is more evidence for the claim than against it - must be truthful and not misleading and indicate the level of scientific support ex: "scientific evidence suggests, but does not prove" " some evidence shows the nutrient may be beneficial, but there is insignificant scientific evidence to prove the effect"

structure/function claims for DS

- may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body ("calcium builds strong bones") - may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure/function ("fiber maintains bowel regularity" or "antioxidants maintain cell integrity") - general wellbeing claims describe general wellbeing from consumption of a nutrient or dietary ingredient (promotes relaxation, etc.) - nutrient deficiency dz claims describe a benefit related to a nutrient deficiency dz (like vit c and scurvy), but such a claim must include statement about how widespread the disease is in the us

special dietary foods

- no premarket approval - supplying a special dietary need that exists by reason of a physical, physiological, pathological or other condition ex: infant formulas, artificial sweeteners, and caloric supplements

rules for cosmetics

- no premarket approval from the fda - structure/function claims not permitted - manufacturer does not have to conform to gmp or register with the fda (registration is voluntary) - fda may remove a cosmetic from the market if it is misbranded, adulterated, or a health hazard - labeling - warning labels - must conform to pppa (poison prevention packaging act)

medical devices - class III

- pharmacies are less likely to sell these - requires premarket approval - life supporting or life-sustaining devices, - important in preventing impairment to human health, - presents a potential unreasonable risk of illness or injury, or - insufficient information exists to determine its safety and effectiveness - ex: pacemakers, soft contact lenses, replacement heart valves

medical devices class I

- pose LEAST potential harm to users - general controls are adequate to ensure safety and effectiveness (subject to the provisions for adulteration, misbranding, registration, banned devices, notifications, records and reports, and other general provisions) - ex: needles, scissors, examination gloves, stethoscopes, toothbrushes

fda dietary supplement final rule june 2007

- requires gmp for ds - ensures ds are produced in good quality manner and do not contain contaminants or impurities and are accurately labeled - manufacturers must evaluate the identity, purity, strength, and composition of their ds - if a ds contains a contaminant or does not contain the dietary ingredients represented on their labeling, the fda would consider them misbranded or adulterated look for usp stamp when buying ds (nature made)

fda conditions for making structure/function claims for ds

- seller must have substantiation that they are truthful and not misleading - label of the product MUST contain the disclaimer: "this statement has not been evaluated by the fda. this product is not intended to diagnose, treat, cure, or prevent any disease." - manufacturer must notify the fda within 30 days if it makes one of the permitted statements

ds - safety issues

- to remove ds from the market, fda must prove the product is adulterated - dshea provides that a product is adulterated if it presents a "significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling; and if no conditions of use are recommended or suggested, then under ordinary conditions of use."

standard used by courts to determine whether manufacturer's claims make it a drug

- what an ignorant, unthinking, and credulous consumer would believe - not what a reasonable consumer would believe ex of claims: lotion composed of bovine albumin and distilled water "lift out puffs" or gives a "facelift without surgery" lotion being of "pure protein" and causing an "astringent sensation"

acceptable/unacceptable: cranberry tablets increase the acidity of the urine and help maintain a healthy urinary tract

acceptable

nutrition labeling and education act of 1990 (nlea)

allowed food labeling to contain a health or disease-prevention claim, but only if the fda had promulgated regulation approving the claim and establishing the conditions under which the claim can be made

device - federal definition

any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or related article which is: - recognized in the usp/nf or hpus or any supplement - intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals - intended to affect the structure of any function of the body of humans or animals but are not foods ex: infusion pumps, cardiac pacemakers, heart monitors, bp, thermometers, etc

drug part b

article intended for use in the diagnosis, cure, mitigation, tx, or prevention of disease in humans or other animals must go through premarket approval of fda because these are health claims

special foods: medical foods

include foods formulated for oral use under the supervision of a physician and that are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation ex: foods formulated without the aa phenylalanine for phenylketonuria, and folic acid, b6, b12 combination products for hyperhomocysteinemia

dshea of 1994

legally created the category of DS and significantly altered fda's authority to regulate them. permits structure/function claims, claims of general wellbeing and claims related to a nutrient deficiency disease general wellbeing ex: an apple a day keeps the doctor away - mandates fda regulate ds more as a special type of food than as a drug - exempts ds from part c definition of a drug and permits structure/function claims as long as no specific disease is mentioned - no premarket approval (manufacturer determines whether product is safe and whether claims are substantiated by adequate evidence; for new products, manufacturer must provide fda with evidence it relie on to prove the claims) - prohibits fda from regulating ds as food additives - fda must prove that a ds is unsafe before it can remove the product from the market

drug part c

structure/function claims