Answers to Self-Assessment Questions - ACCP

Dietary Supplements
61. Answer: B
Information regarding the safety and efficacy of dietary
supplements must be communicated to the consumer by
pharmacists. Although the Federal Trade Commission
(FTC) rather than the FDA regulates advertising of dietary
supplements (Answer A), this fact is not helpful to the
consumer making decisions regarding whether use of such a
supplement is safe and efficacious, and Answer A is incorrect.
Although structure and function claims on the labels of
dietary supplements must be followed by a disclaimer that
the claim has not been evaluated by the FDA (Answer C),
this information mainly addresses efficacy (or lack thereof)
of dietary supplements rather than safety, and Answer C is
incorrect. Although it is now mandated that manufacturers
follow Good Manufacturing Practices (GMPs) as indicated
in Answer D, these address only whether the product
ingredients are consistent with the labeling and ensure that
the product is free of contaminants; GMPs do not address
the efficacy of dietary supplements, making Answer D
incorrect. Informing the consumer that dietary supplements
are regulated more like foods than conventional drugs and
that they do not require premarketing approval by the FDA
(Answer B) should alert them that safety and efficacy could
both be issues with use of the product, making Answer B
correct.
1. Dietary Supplement Current Good Manufacturing Practices
(CGMPs) and Interim Final Rule (IFR) Facts. U.S. Food and
Drug Administration Center for Food Safety and Applied
Nutrition. June 22, 2007. Available at www.cfsan.fda.gov/~dms/
dscgmps6.html. Accessed April 10, 2009.
2. Overview of Dietary Supplements. U.S. Food and Drug
Administration Center for Food Safety and Applied Nutrition.
January 3, 2001. Available at www.cfsan.fda.gov/~dms/dsoview.html#regulate.
Accessed April 10, 2009.
62. Answer: A
The Dietary Supplement Health and Education Act
(DSHEA) of 1994 defined dietary supplements to include
vitamins, minerals, herbs or other botanicals, amino acids,
and other dietary substances that supplement the diet by
increasing total dietary intake. In this case, the patient’s
supplements all fall into one of these categories (folic acid
and ascorbic acid [vitamin C] are vitamins, glucosamine
falls under “other dietary substances,” and ginkgo and green
tea extracts are herbs), making Answer A correct. Answer B
does not include green tea and therefore implies that green
tea extract is not regulated by DSHEA, something that would
be correct if the patient were consuming commercially
available green tea rather than the extract; thus, Answer B is
incorrect. Answer C does not include glucosamine, implying
that it is not regulated by DSHEA; this is incorrect, and
Answer C is not the best answer. Even though glucosamine
is not derived from an herbal source, it is a natural product
that falls in the “other dietary substances” category. Folic
acid in dosages greater than 0.8 mg/day was regulated as
a prescription drug before DSHEA. However, since 1994,
folic acid dosages greater than 0.8 mg/day are considered
dietary supplements and may be sold without a prescription.
Therefore, Answer D, which indicates that folic acid 1 mg is
not regulated by the DSHEA, is incorrect.
1. Overview of dietary supplements. U.S. Food and Drug
Administration Center for Food Safety and Applied Nutrition.
January 3, 2001. Available at www.cfsan.fda.gov/~dms/dsoview.html#regulate.
Accessed April 10, 2009.
2. FDA/CDER Drug Info. Personal communication. May 9, 2008.
Mailed to/from: DRUGINFO@fda.hhs.gov. Accessed October
31, 2008.
63. Answer: C
Ephedra was finally removed from the market as a
weight loss drug by the FDA because it was shown to
cause a significant risk of injury (Answer C); thus, Answer
C is correct. Although the FTC can levy fines for false
advertising, it cannot require that a product be removed from
the market (Answer A); thus Answer A is incorrect. Under
DSHEA, dietary supplements do not have to be shown to
be effective either before or after marketing, thus Answer
B (the FDA removed ephedra from the market because of
ineffectiveness) is incorrect. Ephedra can no longer be sold
as a dietary supplement in the United States; thus Answer D
(ephedra may still be sold as a dietary supplement but not as
a nonprescription drug) is incorrect.
1. Overview of dietary supplements. U.S. Food and Drug
Administration Center for Food Safety and Applied Nutrition.
January 3, 2001. Available at www.cfsan.fda.gov/~dms/dsoview.html#regulate.
Accessed April 10, 2008.
2. Federal Trade Commission. Dietary claims: an advertising
guide for industry. Available at www.ftc.gov/bcp/conline/pubs/
buspubs/dietsupp.shtm. Accessed April 10, 2009.
64. Answer: D
The GMPs apply to both domestic and foreign
manufactured dietary supplements. These long-awaited rules
help ensure the identity, purity, strength, and composition of
dietary supplements and thus will help prevent adulterated
products from reaching the market, making Answer D
correct. Although the GMPs should help promote the safety
of these products, the rules do not require safety testing in
animals or humans (Answer A is incorrect). Similarly, the
GMPs do not address efficacy, so Answer B is incorrect.
No tariffs are levied on foreign products related to the GMP
(Answer C is incorrect); however, implementation of these
new rules will be costly, especially for small companies, and
this may drive up prices of some supplements.
1. U.S. Food and Drug Administration. Dietary supplement
current good manufacturing practices (CGMPs) and interim
final rule (IFR) facts (fact sheet). June 22, 2007. Available at
www.cfsan.fda.gov/~dms/dscgmps6.html. Accessed April 10,
2009.
2. Current good manufacturing practice in manufacturing,
packaging, labeling, or holding operations for dietary
supplements, final rule (21 CFR part 111). Federal Register.
June 25, 2007;72:34751. Available at www.cfsan.fda.gov/~lrd/
fr07625a.html. Accessed April 10, 2009.
65. Answer: B
J.H., a 35-year-old obese woman with mild osteoarthritis,
would like advice on using green tea for weight loss.
Some clinical studies of green tea have demonstrated
benefit in promoting weight loss and weight maintenance,
whereas others have not. Because of the benign nature of
the therapy, especially in patients without hypertension
Pharmacotherapy Self-Assessment Program, 6th Edition 49 Gastroenterology and Nutrition Answers