The document discusses dietary supplements and over-the-counter drugs. It explains that supplements are regulated differently than drugs, as supplements are classified as food and not required to prove effectiveness. The FDA can only declare a supplement unsafe if it presents significant risk, unlike drugs which must prove safety and effectiveness. Labeling rules for supplements are also less strict than drugs. Some supplements to avoid due to safety risks are also listed.

1. Chapter 12
Dietary Supplements
and Over-the-Counter
Drugs
© 2011 McGraw-Hill Higher Education. All rights reserved.

2. Dietary Supplements vs.
Drugs
 Drugs and food share certain
characteristics
 They contain chemicals that interact
with the body’s physiology
 Drugs and food are not regulated
in the same ways
 Supplements may be thought of
as drugs by consumers but are
legally classified as food products
© 2011 McGraw-Hill Higher Education. All rights reserved.

3. Dietary Supplements vs.
Drugs
 Pills, capsules, liquids, and powders classified
as dietary supplements may be thought of as
drugs by consumers BUT
 They are legally classified as food products
 They are treated very differently by the Food and
Drug Administration (FDA)
 Example of Saint John’s wort
 Many people take it for its suggested ability to
improve mood, reduce anxiety, and induce sleep
 Classified as a dietary supplement, it is regulated
more like a food than a drug
© 2011 McGraw-Hill Higher Education. All rights reserved.

4. Food, Drug, and Cosmetic Act
 A drug is a product intended for use in the
diagnosis, cure, mitigation, treatment, or
prevention of disease
 Before marketing, drugs must be shown to be
 Safe when used as directed
 Effective for their intended use
 Food products and ingredients must be
 Safe
 Pure (unadulterated)
 They are not required to show that they are
effective or provide any benefit
© 2011 McGraw-Hill Higher Education. All rights reserved.

5. Dietary Supplements:
Regulation
 Dietary Supplement Health and
Education Act (DSHEA) of 1994
 Passed in part due to pressure on
Congress from the supplement industry in
response to indications that the FDA was
planning to expand regulation of dietary
supplements
 Defined supplements and set
regulations for safety and labeling
© 2011 McGraw-Hill Higher Education. All rights reserved.

6. DSHEA: Supplement Labeling
 Same label format as those for packaged foods
 Not as accurate or precise as drug labels
 Testing has found that potency varies from bottle to
bottle and even capsule to capsule
 Amounts listed on label are for a plant substance and not
the presumed active ingredient
 Ingredients listed on the label may not be the actual
active ingredients in a plant or herb
 Dosage guidelines are not well-established for many
supplements
 There is no requirement for proof of effectiveness
© 2011 McGraw-Hill Higher Education. All rights reserved.

7. DSHEA: Defining Dietary
Supplements
 DSHEA expanded the definition of supplements
to include a variety of substances:
 Vitamins and minerals
 Herbs and concentrates and extracts of herbs
 Amino acids
 Many forms:
 Tablets
 Capsules
 Liquids
 Powders
© 2011 McGraw-Hill Higher Education. All rights reserved.

8. DSHEA: Defining Supplement
Safety
 FDA can declare a product to be adulterated
(unsafe) only if it presents a significant or
unreasonable risk of illness or injury
 Ingredients already on the market at the time
of the Act:
 Considered safe enough to be sold unless the FDA
can demonstrate a risk
 New ingredients:
 Need some evidence that they would not present a
significant or unreasonable risk
 BUT much less evidence is required than for drugs
© 2011 McGraw-Hill Higher Education. All rights reserved.

9. Supplement Labeling:
Health Claims
 FDA authorizes a small number of
health claims that food and supplement
manufacturers can use if their products
meet certain requirements
 Based on available scientific research
 Examples:
 Adequate calcium intake and reduced risk of
osteoporosis
 Soluble fiber intake and reduced risk of heart
disease
© 2011 McGraw-Hill Higher Education. All rights reserved.

10. Supplement Labeling:
Structure/Function Claims
 Unapproved health claims are not
allowed, BUT
 Supplement labels can make so-called
structure/function claims
 Relate to the structure or functioning of the
body or to overall well-being
 Examples:
 Maintains cell integrity
 Supports the immune system
© 2011 McGraw-Hill Higher Education. All rights reserved.

11. Supplement Labeling:
Structure/Function Claims
 Not a claim to prevent or treat a disease
 Not reviewed by the FDA
 Must carry a disclaimer:
 This statement has not been evaluated
by the Food and Drug Administration.
This product is not intended to diagnose,
treat, cure, or prevent any disease.
© 2011 McGraw-Hill Higher Education. All rights reserved.

12. Supplement Labeling
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13. Pros and Cons of Current
Supplement Regulations
 Pro: Many more supplements on the market
 Consumers have more options
 Con: Much less research available about safety and
effectiveness of supplements
 Con: Supplements remain on the market unless or
until the FDA presents clear evidence of risk
 Example: Ephedra, a stimulant taken by people
wanting to lose weight
 First evidence of safety concerns published by the FDA in
1994
 With the burden of proof now with the FDA, it took 10
additional years for the FDA to compile evidence to get
ephedra off the market
© 2011 McGraw-Hill Higher Education. All rights reserved.

14. Supplements to Avoid
 Definitely hazardous  Likely hazardous
 Aristolochic acid  Bitter orange
 Very likely  Organ/glandular extracts
hazardous  Lobelia
 Comfrey
 Pennyroyal oil
 Androstenedione
 Scullcap
 Chaparral
 Yohimbe
 Germander
 Kava
 Cesium
 Colloidial Siver
 Graviola
© 2011 McGraw-Hill Higher Education. All rights reserved.

15. Dietary Supplement Act
 Introduced by Senator John McCain in
February 2010.
 Would have required all manufacturers to
register with the FDA and provide a complete
list of ingredients.
 The FDA could also recall any ingredient they
found to be unsafe.
 The dietary supplement industry mounted a
campaign against the regulation and McCain
withdrew the bill
© 2011 McGraw-Hill Higher Education. All rights reserved.

16. Examples of Psychoactive
Dietary Supplements
 Saint John’s wort (Hypericum perforatum)
 Was originally thought to prevent possession by
demons
 Currently used as a potential treatment for both
anxiety and depression
 Research results have been
mixed, but there is some
evidence supporting its use for
depression
 It may interact with prescription
drugs, so users should notify their
physicians
© 2011 McGraw-Hill Higher Education. All rights reserved.

17. Examples of Psychoactive
Dietary Supplements
 S-adenosyl-L-methionine (SAMe)
 A naturally occurring substance, the active
form of amino acid methionine
 Researched as a possible antidepressant
 Not yet any solid evidence it is more
effective than placebo
© 2011 McGraw-Hill Higher Education. All rights reserved.

18. Examples of Psychoactive
Dietary Supplements
 Ginkgo biloba
 Long history of medical use in China
 Active ingredients and mechanisms of action
haven’t yet been identified
 Reduces blood clotting; thins blood to improve
circulation
 Potentially risky if used with aspirin or other drugs
that reduce clotting
 Research suggests a slight
ability to improve memory
© 2011 McGraw-Hill Higher Education. All rights reserved.

19. Dietary Supplements vs.
Drugs: Review
 Supplements: no requirement for proof
of effectiveness
 Disclaimer for any structure/function
claim:
 “This statement has not been evaluated by
the Food and Drug Administration. This
product is not intended to diagnose, treat,
cure, or prevent any disease.”
© 2011 McGraw-Hill Higher Education. All rights reserved.

20. Over-the-Counter (OTC)
Drugs
 A drug is a product intended for use in the
diagnosis, cure, mitigation, treatment, or
prevention of disease
 Usage by Americans
 Americans self-treat four
times as many health
problems as doctors treat,
often with OTC drugs
 Americans spend over
$18 billion per year
on OTC drugs
© 2011 McGraw-Hill Higher Education. All rights reserved.

21. OTC Regulation
 1962 Kefauver-Harris amendment required that all
drugs be evaluated for safety and efficacy
 Active ingredients reviewed individually; three
standards considered:
1. GRAS (generally recognized as safe) means that,
given currently available information, the ingredient is
considered safe
 Nothing is entirely safe
 Safe = a “low incidence of adverse reactions or significant
side effects under adequate directions for use and warnings
against unsafe use as well as low potential for harm which
may result from abuse”
© 2011 McGraw-Hill Higher Education. All rights reserved.

22. OTC Regulation
2. GRAE (generally recognized as
effective) = a reasonable expectation
that the pharmacological effect of the
drug will provide clinically significant
relief of the type claimed in a
significant proportion of the target
population
© 2011 McGraw-Hill Higher Education. All rights reserved.

23. OTC Labeling
3. GRAHL (generally recognized as
honestly labeled)
 More than 300,000 OTC products on the
market contain fewer than 1,000 total
active ingredients now reviewed in over
80 therapeutic classes.
 Those that the FDA has classified as safe and
effective
© 2011 McGraw-Hill Higher Education. All rights reserved.

24. OTC Labeling
 Uniform labeling standards were adopted in 1997 to
reduce consumer confusion
 Layout, headings, and
topics are consistent,
and language has been
made clearer and more
concise, with less
medical terminology
 Consistent labels make
it easier for consumers
to compare products
© 2011 McGraw-Hill Higher Education. All rights reserved.

25. OTC Labeling
© 2011 McGraw-Hill Higher Education. All rights reserved.

26. OTC vs. Prescription Drugs
 1938 Food, Drug, and Cosmetic Act
established a classification of drugs that can
be sold only by prescription
 Possible differences between OTC and
prescription drugs
 Dosage: An OTC version of a drug may come in
smaller doses
 Chemicals: A prescription drug may contain a
chemical not allowed for OTC sale due to
potential toxicity
© 2011 McGraw-Hill Higher Education. All rights reserved.

27. OTC vs. Prescription Drugs
 FDA panels review products and may switch
drugs to OTC status
 Examples of drugs switched to OTC status
include ibuprofen (analgesic), orlistat (weight-
loss), and cetirizine (antihistamine)
 Should there be a class
of drugs between OTC
and prescription?
Pharmacist
recommended?
© 2011 McGraw-Hill Higher Education. All rights reserved.

28. Examples of Psychoactive
OTC Drugs
 Stimulants
 FDA allows stimulants to be sold to “help
restore mental alertness or wakefulness
when experiencing fatigue or drowsiness”
 Only ingredient allowed by FDA in OTC
stimulants is caffeine
 Combinations of caffeine and other
stimulants (e.g., ephedrine) are not allowed
© 2011 McGraw-Hill Higher Education. All rights reserved.

29. Examples of Psychoactive
OTC Drugs
 Weight-control products
 Phenylpropanolamine (PPA) was sold over
the counter by the late 1970s
 Combinations of PPA and caffeine sold for
a brief period before being banned in 1983
 Concerns over effectiveness of PPA and
the safety of recommended dosage due to
its effects on blood pressure
 2000: FDA requested all companies to stop
marketing products containing PPA
© 2011 McGraw-Hill Higher Education. All rights reserved.

30. Examples of Psychoactive
OTC Drugs
 Weight-control products
 Additional products banned due to lack of
safety or effectiveness
 Ephedrine
 Benzocaine-containing candies and gums
 Starch blockers
 Cholecystokinin (CCK)
 Currently, one FDA-approved weight-
control OTC drug: Orlistat (alli)
© 2011 McGraw-Hill Higher Education. All rights reserved.

31. Examples of Psychoactive
OTC Drugs
 Sedatives and sleep aids
 Early OTC sedatives and sleep aids
 acetylcholine receptor blocker scopolamine +
antihistamine methapyrilene
 FDA review panel eventually rejected scopolamine but
accepted methapyrilene
 Later methapyrilene was found to cause cancer in rats, so
it was no longer classified as GRAS
 Different antihistamines were then marketed, and
brands changed active ingredients frequently
 Currently, there are no approved OTC sedatives;
OTC sleep aids contain antihistamines
© 2011 McGraw-Hill Higher Education. All rights reserved.

32. OTC Analgesics: Pain and
People
 Anesthetics (“without sensibility”) reduce all types of
sensation or block consciousness completely
 Analgesics (“without pain”) reduce pain selectively
without causing a loss of other sensations
 Types of pain, based on place of origin
 Visceral pain from nonskeletal portions of the body
 Relieved by opioids
 Somatic pain from muscle or bone
 Relieved by aspirin and related products
 About 35 percent of patients obtain pain relief from a
placebo
© 2011 McGraw-Hill Higher Education. All rights reserved.

33. OTC Analgesics:
Acetylsalicylic Acid (Aspirin)
 Development
 Long historical use of teas and extracts of willow
and poplar bark for pain relief
 Active ingredient—salicylic acid—was identified,
synthesized, and mass-produced in the nineteenth
century
 Related compound—acetylsalicylic acid—was
synthesized in 1898 by a Bayer Laboratories’
chemist; had fewer side effects
 1899: Patented and released for prescription sale in the
form of a white powder
 1915: Sold over the counter in tablet form
© 2011 McGraw-Hill Higher Education. All rights reserved.

34. OTC Analgesics:
Acetylsalicylic Acid (Aspirin)
 Therapeutic use
1. Analgesic—effectively blocks mild-to-moderate
somatic pain
 Maximum pain relief occurs in about one hour; effect
lasts for up to four hours
 Especially effective for headache and musculoskeletal
pain
1. Antipyretic—reduces fever
 Does not lower body temperature in someone with
normal body temperature
 Causes vasodilation of peripheral blood vessels and
increased perspiration
© 2011 McGraw-Hill Higher Education. All rights reserved.

35. OTC Analgesics:
Acetylsalicylic Acid (Aspirin)
 Therapeutic use
3. Anti-inflammatory—reduces swelling,
inflammation and soreness
 Relatively low toxicity
 Absorbed from the stomach and intestines
© 2011 McGraw-Hill Higher Education. All rights reserved.

36. OTC Analgesics:
Acetylsalicylic Acid (Aspirin)
 Effects/Risks
 Increases bleeding time by inhibiting blood platelet
aggregation
 Can cause bleeding problems for surgical patients
 May prevent heart attacks and strokes by preventing clots in
high-risk patients
 Induces gastrointestinal bleeding
 Reye’s syndrome—rare but serious disease
 Effects can include disorientation, personality changes, lethargy,
coma, and death
 CDC recommends that aspirin should not be given to anyone
under age 20 who has a suspected viral illness such as cold,
influenza, or chicken pox
 Accidental poisonings and suicide attempts
© 2011 McGraw-Hill Higher Education. All rights reserved.

37. OTC Analgesics:
Acetylsalicylic Acid (Aspirin)
 Mechanism of action
 Prostaglandins are local-acting hormones
 Released when cell membranes are injured
 Mediate pain in injured areas by sensitizing
neurons to stimulation
 Aspirin inhibits two forms of the
cyclooxygenase (COX) enzyme
 Blocks the synthesis of pain-causing
prostaglandins
 Aspirin also acts on prostaglandins involved
in heat regulation
© 2011 McGraw-Hill Higher Education. All rights reserved.

38. OTC Analgesics:
Acetaminophen
 Acetaminophen is closely related to
phenacetin, a now banned pain reliever
 Compared to aspirin:
 As effective in analgesic and antipyretic effects
 Less useful as an anti-inflammatory drug
 Causes less gastric bleeding
 Overuse of acetaminophen can cause serious
liver disorders
 Not safer than aspirin if recommended dose is
exceeded
 As of 2009, the FDA limited the maximum single
adult dose to 650 mg for OTC products
© 2011 McGraw-Hill Higher Education. All rights reserved.

39. OTC Analgesics: Ibuprofen
and Other NSAIDs
 Ibuprofen is an aspirin-like analgesic and
anti-inflammatory; it also inhibits COX
enzymes
 Potential side effects
 Nausea and stomach pain
 Liver damage (if taken in large amounts)
 Class of drugs is known as nonsteroidal
anti-inflammatory drugs (NSAIDs)
 Originally available by prescription, but now
also available over the counter
© 2011 McGraw-Hill Higher Education. All rights reserved.

40. OTC Cold and Allergy
Remedies
 All-too-common cold
 Colds are viral infections, caused by
viruses in the rhinovirus or
coronavirus families
 Viruses damage or kill the cells they
attack
 In the case of colds, the affected cells are
on the upper respiratory tract
 Symptoms include coughing, sneezing,
and production of fluid by the mucous
membranes
© 2011 McGraw-Hill Higher Education. All rights reserved.

41. OTC Cold and Allergy
Remedies
 All-too-common cold
 Most cold viruses enter the body through
the nose or eyes; they are usually
transmitted via an infected person’s hands
 Frequent handwashing is a good strategy
to reduce the risk of contracting a cold
© 2011 McGraw-Hill Higher Education. All rights reserved.

42. OTC Cold and Allergy
Remedies
 Treatment of cold symptoms—no cure
 Modern cold remedies contain three
common types of ingredients
 Antihistamines for temporary relief of runny
nose and sneezing
– Of questionable benefit for cold symptoms
 Nasal decongestants for temporary relief of
swollen nasal membranes
 Analgesic-antipyretics for temporary relief of
aches and pains and fever reduction
© 2011 McGraw-Hill Higher Education. All rights reserved.

43. OTC Cold and Allergy
Remedies
 Allergy and sinus medications
 Rely mainly on antihistamines
 May also include an analgesic
© 2011 McGraw-Hill Higher Education. All rights reserved.

44. Choosing an OTC Product
 Most products contain one or more of only a
small number of ingredients, in different
combinations
 An informed consumer can understand a large
proportion of these products by being familiar with
only a few drugs
 Single ingredient medications may be
preferable to combination products
 Avoid medication interactions and side effects of
drugs that are designed to treat symptoms you may
not have
© 2011 McGraw-Hill Higher Education. All rights reserved.

45. Chapter 12
Dietary Supplements
and Over-the-Counter
Drugs
© 2011 McGraw-Hill Higher Education. All rights reserved.