prohibited from marketing products that are adulterated or misbranded. That
means that these firms are responsible for evaluating the safety and labeling of
their products before marketing to ensure that they meet all the requirements of
DSHEA and FDA regulations.
FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.
Dietary supplement manufacturere must get FDA approval before producing or selling dietary supplements
they regulate dietary supplement advertising
(The FDA regulates dietary supplement labels and other labels, such as package inserts and accompanying literature)
-herbs & other botanicals
-enzymes, organ tissues, glandulars and metabolites
Dietary supplements are marketed in forms such as tablets, capsules, softgels, gelcaps, powders, energy bars, and drinks.
>> placed under the general umbrella of “foods” not drugs
-an herb or other botanical
-an amino acid
-a dietary substance used by man to supplement the diet by increasing the total dietary intake
(enzyme or tissues from organs or glands)
-a concentrate, metabolite, constituent, or extract
a “new dietary ingredient” meets the above, and was not sold in the US in a dietary supplement before Oct. 15, 1994
>> so dietary supplements do not need approval from FDA before they are marketed
The FDA has comprehensive regulations for Current Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products that manufacturers must follow. These regulations focus on practices that ensure the identity, purity, quality, strength, and composition of the products
– name and place of the business of the manufacturer, packer or distributor
-complete list of ingredients
net contents of the product
– nutrition labeling in the form of a “supplement facts” panel that identifies each ingredient in the product
>> all dietary ingredients, other food ingredients, and technical additives or processing aids
unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for the FDA to “approve” dietary supplements for safety and effectiveness before they reach the consumer.
>>the manufacturer must record any adverse event associated with their products and report to the FDA for their evaluation
FDA can take dietary supplements off the market if they are found to be unsafe,
adulterated, or if the claims on the products are false and misleading.
analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.
considered an unapproved–and thus illegal–drug.
3 types of claims can be made:
-nutrient content claims
Any claim describing the role of a nutrient or dietary ingredient intended to affect the structure or function of the body has not been evaluated by the FDA.
It may also not say it’s intended to diagnose, treat, etc. because legally only a drug can make this claim
then the patient or their HCP can file a report by submitting a form online, or contacting the FDA by phone
– FDA’s MedWatch Program
Glucosamine and/or Chonodroitin Sulphate
Omega-3 Fatty Acids
St. John’s Wort
essential nutrients. However, supplements should not replace the variety of foods that
are important to a healthful diet — so, be sure you eat a variety of foods as well.
Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure
diseases. That means supplements should not make claims, such as “reduces
arthritic pain” or “treats heart disease.” Claims like these can only legitimately be
made for drugs, not dietary supplements.
> Using supplements with medications (whether prescription or over-the-counter)
> Substituting supplements for prescription medicines
> Taking too much of some supplements, such as vitamin A, vitamin D, and iron
Some supplements can also have unwanted effects before, during, and after surgery. It’s important for patients to inform their health-care provider, including their pharmacist, about any
supplements they are taking — especially before surgery.
>A quick and effective “cure-all”
>Can treat or cure diseases
>”Totally safe” or has “no side effects”
Be aware that the term natural doesn’t always mean safe.
Don’t assume that even if a product may not help you, at least it won’t hurt you.
When searching for supplements on the Web, use the sites of respected organizations, rather than doing blind searches.
See the FDA’s Tainted Supplements page for a list of some of the potentially hazardous
dietary supplements marketed to consumers.
Ask your health-care provider for help in distinguishing between reliable and questionable information.
Always remember — safety first!
While you need enough nutrients, too much of some nutrients can cause problems.
While vitamin and mineral supplements are widely used and
generally considered safe for children, you may wish to check with your doctor or pharmacist before giving these or any other dietary supplements to your child.
If you plan to use a dietary supplement in place of drugs or in combination with any drug, tell your health care provider first. Many supplements contain active ingredients that have strong biological effects and their safety is not always assured in all users. If you have certain health conditions and take these products, you may be placing yourself at risk.
Be alert to advisories about these products, whether taken alone or in combination.
For example: Coumadin (a prescription medicine), ginkgo biloba (an herbal supplement), aspirin (an OTC drug) and vitamin E (a vitamin supplement) can each thin the blood, and taking any of these products together can increase the potential for internal bleeding.
Combining St. John’s Wort with certain HIV drugs significantly reduces their effectiveness. St. John’s Wort may also reduce the
effectiveness of prescription drugs for heart disease, depression, seizures, certain cancers or oral contraceptives.
It is best to stop taking these products 2-3 weeks ahead of time.
2) what is the purpose of the site
>> to educate the public or just sell a product?
3) What is the source of the information and does it have any references?
4) is the information current?
5) How reliable is the internet or email solicitations?
6) Does is sound too good to be true?
>> it usually is…
7) think twice about chasing the latest headline
>> a “quick fix” is rarely reliable. science proceeds by taking many small steps that build towards something
-“Even if a product may not help me, it at least won’t hurt me.”
-“When I see the term ‘natural,’ it means that a product is healthful and safe.”
-” A product is safe when there is no cautionary information on the product label.”
-” A recall of a harmful product guarantees that all such harmful products will be
immediately and completely removed from the marketplace.”
It is a new reporting method that is an all electronic version of the MedWatch 3500, 3500A, and 3500B forms tailored exclusively for dietary supplements