Exam 2 Flashcards
*How are dietary supplements defined?
Dietary Supplement Health and Education Act (DSHEA) -
Includes herbal medicines in the definition of a dietary supplement,
assures consumers access to all supplements on the market as long as
they are not determined to be unsafe, and allows for structure and
function claims to appear on the label.
“dietary ingredients” in dietary supplements may include
vitamins,
minerals, herbs, and amino acids as well as substances such as
enzymes, organ tissues, metabolites, extracts or concentrates.
Dietary supplements can be found in many forms such as
pills, tablets, capsules,
liquids or powders.
They must be identified on the label as a
dietary
supplement.
*How are dietary supplements treated differently from drugs by the FDA?
- No safety data required for products available before
DSHEA enacted - Previously no mandatory reporting of adverse events
- No requirement for product potency or consistency
unless labeled as such (USP) - No requirements that inferred benefits are true or
Tested
Variability in DS product content is
potentially high
* Product content is not stipulated by FDA
* Most studies are small
– High likelihood of negative publication bias
* Most studies are short
– Long term benefit and/or toxicities less well
characterized
Unsafe Botanicals are the Exception
- Drug-Herb Interactions appear to have far greater potential
for unintended harm than adverse effects arising directly from
common supplements - Exceptions (Recognized herbs with specific adverse effects):
– Aconite Guar Gum (obstruction)
– Licorice Root Pennyroyal
– Pyrrolizidine alkaloids Mistletoe/Skullcap
– Allergic Reactions Aristolochic Acid
– Broom Chapparal
– Comfrey Ephedra
– Germander Heavy Metal Adulteration
*What guidance is provided by the FDA on the appropriate use of
dietary supplements?
- If the FDA (law) dose not allow supplements
to carry drug claims, then the FDA cannot say
whether they are effective or not - Product content cannot be stipulated
- Similarly, the FDA cannot state that one brand
or mixture of dietary supplement is more
effective than another.
– It would again infer that the “better” one had
drug-like effects, which cannot be claimed.
Some Supplements can provide data
to support “Health Claims”
example: calcium
– “Regular exercise and a healthy diet with enough
calcium helps teen and young adult white and
Asian women maintain good bone health and may
reduce their high risk of osteoporosis later in life.”
Soy Health Claim
- “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of food) provides __ grams of soy protein.”
To qualify for the claim foods must contain per serving:
* 6.25 grams of soy protein
* low fat (less than 3 grams)
* low saturated fat (less than 1 gram)
* Low cholesterol (less than 20 milligrams)
* sodium value of less than 480 milligrams for individual foods, less than 720 milligrams if considered a main dish, and less than 960 milligrams if considered a meal.
DSHEA - Labeling Requirements
* Labeling must not:
– Claim to diagnose, prevent, mitigate, treat, or cure
a specific disease or class of diseases;
- Labeling may:
– Describe the role of a nutrient or dietary
ingredient intended to affect the structure or
function in humans
Examples of Labeling
- Silymarin
– Prohibited: Improves alcoholic cirrhosis
– Allowed: Supports normal liver function
- Echinacea
– Prohibited: Prevents colds and flu
– Allowed: Helps support immune function
If the FDA (law) dose not allow supplements
to carry drug claims, then the FDA cannot say
whether they are effective or not
* Product content cannot be stipulated
* Similarly, the FDA cannot state that one brand
or mixture of dietary supplement is more
effective than another.
– It would again infer that the “better” one had
drug-like effects, which cannot be claimed.
Protecting Intellectual Property
- Supplement manufacturers often will combine
ingredients into “proprietary blends”.
proprietary blends label
– The label must include the components and the
total weight of the mixture
– The label DOES NOT need to include the exact
amount of each ingredient
* As with foods, the most prevalent component is listed
first, etc..
* No need to demonstrate benefit of mixture
Dietary supplement labels
suggested use and dose as a claim and is not required
also does not necessarily have to match SFB information
all other ingreedients including excipients, lubricants, and capsule material must be listed below SFB
A growing number of dietary supplements
have been shown to have beneficial activity in
well controlled clinical trials
- There is no current control over the content of
even the “effective” products - Even “certified” products may vary over time
Agnus Castus (Vitex)
Common uses:
symptoms of premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), dysmenorrhea, mastalgia, and menopausal symptoms.
Agnus Castus (Vitex) Adverse effects:
GI complaints occur occasionally with use of chasteberry. Other symptoms include dry mouth, headache, rashes, itching, acne, menstrual disorders, and agitation. Chasteberry should be avoided during pregnancy because of insufficient data to support safe use and the possibility of lactation suppression. Theoretically, chasteberry may interact with medications that impact dopamine, as well as hormone replacement therapies and oral contraceptives.
Curcumin/Tumeric
Common uses:
arthritis and inflammatory conditions.
Curcumin/Tumeric
Adverse Effects
The most common side effects are GI discomfort and nausea. Human studies show good tolerance with doses as high as 12,000 mg daily.
Curcumin inhibits platelet aggregation, so patients on antithrombotic agents should use curcumin cautiously.
Glucosamine Common uses
osteoarthritis (OA) and joint health
Glucosamine Adverse Effects
Adverse effects for both components include mild GI upset, nausea, diarrhea,
and constipation, which can often be alleviated by taking divided doses with
meals. Drowsiness, headache, and skin reactions have been reported infrequently with glucosamine
Bitter Melon
Common uses:
increased cellular glucose uptake, decreased gluconeogenesis in the liver, and increased insulin secretion.
was able to significantly reduce fasting plasma glucose, postprandial glucose