FDA Role in Assessing CAM: Janet McDonald, PhD. Course Reader: pp. 35-41, Dr. McDonald’s handouts. Flashcards
Know the name and provisions of the 1994 Dietary Supplement Health and Education Act (DSHEA) law.
was enacted by Congress following public debate concerning the importance of dietary supplements in promoting health, the need for consumers to have access to current and accurate information about supplements, and controversy over the Food and Drug Administration’s (FDA) regulatory approach to this product category.
major provisions:
short title, reference, table of contents
congressional findings
definitions
safety of dietary supplements & burden of proof on FDA
dietary sup claims
statements of nutritional support
dietary supp ing labeing & nutrition info
new dietary ings
Know the effects of this law on the American consumer.
Some DS can harm the consumer if taken wrong
Define dietary supplements according to the DSHEA law.
a dietary supplement is a product (other than tobacco) that
is intended to supplement the diet
contains one or more dietary ingredients (including vitamins; minerals; herbs; other botanicals; amino acids; and other substances) or their constituents
is intended to be taken by mouth as a pill, capsule, tablet, or liquid
is labeled on the front panel as being a dietary supplement
What are the distinctions (claims, labeling, testing, and marketing) between drugs and dietary supplements?
Drug manufacturers may claim that their product will diagnose, cure, mitigate, treat, or prevent a disease.
such claims may not legally be made for dietary supplements.
The label of a dietary supplement or food product may contain one of three types of claims:
A health claim
describes a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition.
A nutrient content claim
describe the relative amount of a nutrient or dietary substance in a product.
A structure/function claim
a statement describing how a product may affect the organs or systems of the body and it can not mention any specific disease.
do not require FDA approval but the manufacturer must provide FDA with the test of the claim within 30 days of putting the product on the market.
What is the priority of the FDA in regards to regulating dietary supplements?
There are no provisions in the law for FDA to “approve” dietary supplements for safety or effectiveness before they reach the consumer. Once a dietary supplement is marketed, FDA has to prove that the product is not safe in order to restrict its use or remove it from the market.
In contrast, before being allowed to market a drug product, manufacturers must obtain FDA approval by providing convincing evidence that it is both safe and effective.
The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, FDA may remove the product from the marketplace or take other appropriate actions.
What are some risks in taking dietary supplements?
dietary supplements are not FDA-approved
therefore, it isn’t guaranteed that it is safe
many supplements contain active ingredients that have strong biological effects in the body. This could make them unsafe in some situations and hurt or complicate your health.
The following actions could lead to harmful – even life-threatening consequences
combining supplements
using supplements with medicines (whether prescription or over-the-counter)
substituting supplements for prescription medicines
taking too much of some supplements, such as vitamin A, vitamin D, or iron
Some supplements can also have unwanted effects before, during and after surgery.
What are the responsibilities of a manufacturer of a dietary supplement?
The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to the market
If the dietary supplements contains a NEW ingredient, manufacturers must notify FDA about that ingredient prior to marketing. However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness.
Manufacturers are required to produce dietary supplements in a quality manner and ensure that they do not contain contaminants or impurities, and are accurately labeled according to current Good Manufacturing Practice (cGMP) and labeling regulations.
If a serious problem associated with a dietary supplement occurs, manufacturers must report it to FDA as an adverse event. FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.
What are GMP’s?
Good Manufacturing Practices
a set of requirements and expectations by which dietary supplements must be manufactured, prepared, and stored to ensure quality.
How does the FDA monitor safety of supplements in the marketplace (Give some specific examples).
They may investigate history of use, (for example scientist know that calcium and Vit D are important for keeping bones strong and reducing bone loss due to research)
They can conduct laboratory studies using cell or tissue cultures, and
Experiment with animals
