Week 12

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

Dietary supplement manufacturere must get FDA approval before producing or selling dietary supplements
False; although they must register their facilities with the FDA
What does the FTC regulate ?
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)

What is a dietary supplement?
a dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.
-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

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

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

When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the US?
if the product contains a “new dietary ingredient”
What information must the manufacturer disclose on the label of a dietary supplement?
– 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
must all ingredients be declared on the label of a dietary supplement?
>> all dietary ingredients, other food ingredients, and technical additives or processing aids
Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?
there are no rules that limit a serving size or the amount of a nutrient other than the manufacturer’s responsibility to ensure safety.
Where can I get information about a specific dietary supplement?
Contact the manufacturer of that brand directly. The name and address of the manufacturer can be found on the label
Who has the responsibility for ensuring that a dietary supplement is safe? the manufacturer
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.

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?
no, except for rules that govern “new dietary ingredients”
How can consumers inform themselves about safety and other issues related to dietary supplements
they can first contact the manufacturer
What is the FDA’s oversight responsibility for dietary supplements?
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.
Does FDA routinely analyze the content of dietary supplements?
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.
Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
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.
Who validates claims on dietary supplement labels, and what kinds of claims can be made?
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
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”
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

How are advertisements for dietary supplements regulated?
the FTC
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?
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

what are some common dietary supplements?
Glucosamine and/or Chonodroitin Sulphate
Omega-3 Fatty Acids
St. John’s Wort
Saw Palmetto
what are the benefits of dietary supplements?
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.

What are the risks in taking supplements>
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.

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

Why should someone consider their total diet when taking a supplement?
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.
Why should someone check with a doctor or healthcare provider before using a supplement?
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.

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

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

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

-“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.”

How can you tell if a certain product is a dietary supplement and not a food or drug product?
It will have a “Supplement Facts” label on the product
What is the Safety Reporting Portal?
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