Please enter something

Week 12 – Flashcard

question

What does the Dietary Supplement Health and Education Act of 1994 (DSHEA) state?
answer

Manufacturers and distributors of dietary supplements and dietary ingredients are 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.
question

True/False Dietary supplement manufacturere must get FDA approval before producing or selling dietary supplements
answer

False; although they must register their facilities with the FDA
question

What does the FTC regulate ?
answer

FTC = Federal Trade Commission they regulate dietary supplement advertising (The FDA regulates dietary supplement labels and other labels, such as package inserts and accompanying literature)
question

What is a dietary supplement?
answer

a dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. -vitamins -minerals -herbs & other botanicals -amino acids -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
question

What is a “new dietary ingredient” in a dietary supplement?
answer

a dietary ingredient must be one or any combination of the following: -a vitamin -a mineral -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
question

What is the FDA’s role in regulating dietary supplements vs. the manufacturer’s responsibility for marketing them?
answer

A firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations of claims made about them are substantiated by adequate evidence to show that they are not false or misleading. >> 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
question

When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the US?
answer

if the product contains a “new dietary ingredient”
question

What information must the manufacturer disclose on the label of a dietary supplement?
answer

– a descriptive name of the product stating that it is a supplement – 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
question

must all ingredients be declared on the label of a dietary supplement?
answer

Yes >> all dietary ingredients, other food ingredients, and technical additives or processing aids
question

Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?
answer

there are no rules that limit a serving size or the amount of a nutrient other than the manufacturer’s responsibility to ensure safety.
question

Where can I get information about a specific dietary supplement?
answer

Contact the manufacturer of that brand directly. The name and address of the manufacturer can be found on the label
question

Who has the responsibility for ensuring that a dietary supplement is safe? the manufacturer
answer

the manufacturer 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.
question

Do manufacturers or distributors of dietary supplements have to tell the FDA or consumers what evidence they have about their product’s safety or what evidence they have to back up the claims they are making for them?
answer

no, except for rules that govern “new dietary ingredients”
question

How can consumers inform themselves about safety and other issues related to dietary supplements
answer

they can first contact the manufacturer
question

What is the FDA’s oversight responsibility for dietary supplements?
answer

Because dietary supplements are under the “umbrella” of foods, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency’s oversight of these products. FDA’s efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occasional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.
question

Does FDA routinely analyze the content of dietary supplements?
answer

The FDA has limited funds to analyze the composition of food products including dietary supplements. There is routine monitoring of products pulled from store shelves or collected during inspections, but analysis is usually left to the manufacturer. If consumers want to know what the content of a dietary supplement is, the FDA will usually contact the manufacturer before doing an analysis themselves.
question

Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
answer

No, a product sold as a dietary supplement and promoted on its label or in labeling as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved–and thus illegal–drug.
question

Who validates claims on dietary supplement labels, and what kinds of claims can be made?
answer

The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and in the case of advertising, with the FTC (Federal Trade Commission). 3 types of claims can be made: -health claims -structure/function claims -nutrient content claims
question

Why do some supplements have wording (a disclaimer) stating that: “this statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”
answer

It is required by law (DSHEA) when a manufacturer makes a structure/function claim on a label. 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
question

How are advertisements for dietary supplements regulated?
answer

the FTC
question

How does a patient, their health care provider, or any informed individual report a problem or illness caused by a dietary supplement to the FDA?
answer

if someone has suffered a serious harmful effect or illness, they should contact their HCP immediately 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
question

what are some common dietary supplements?
answer

Acidophilus Echinacea Fiber Ginger Glucosamine and/or Chonodroitin Sulphate Minerals Omega-3 Fatty Acids St. John’s Wort Saw Palmetto Vitamins
question

what are the benefits of dietary supplements?
answer

Some supplements may help to assure that you get an adequate dietary intake of 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.
question

What are the risks in taking supplements>
answer

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. For example, the following actions could lead to harmful —even life-threatening — consequences. > 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.
question

How can one be a “smart supplement shopper”?
answer

Watch out for false statements like: >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!
question

Why should someone consider their total diet when taking a supplement?
answer

Dietary supplements are intended to supplement the diets of some people, but not to replace the balance of the variety of foods important to a healthy diet. While you need enough nutrients, too much of some nutrients can cause problems.
question

Why should someone check with a doctor or healthcare provider before using a supplement?
answer

Dietary supplements may not be risk-free under certain circumstances. If you are pregnant, nursing a baby, or have a chronic medical condition, such as, diabetes, hypertension or heart disease, be sure to consult your doctor or pharmacist before purchasing or taking any supplement. 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.
question

What is the potential risk of taking a supplement in combination with other prescription or OTC medications?
answer

Some supplements may interact with prescription and over-the-counter medicines. Taking a combination of supplements or using these products together with medications (whether prescription or OTC drugs) could under certain circumstances produce adverse effects, some of which could be life-threatening. 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.
question

Why is it important to inform your physician about any vitamins, minerals, herbals, or other supplements you are taking before surgery?
answer

Some supplements can have unwanted effects during surgery such as changes in heart rate, BP, and increased bleeding, that can adversely affect the outcome of the surgery. It is best to stop taking these products 2-3 weeks ahead of time.
question

What questions should someone ask themselves when searching the web for information on dietary supplements?
answer

1) who operates the site 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 MYTHS: -“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.”
question

How can you tell if a certain product is a dietary supplement and not a food or drug product?
answer

It will have a “Supplement Facts” label on the product
question

What is the Safety Reporting Portal?
answer

The SRP is a convenient, secure, and efficient method for letting the FDA know when industry or consumers find a a problem with a dietary supplement. 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