[Music]
[Host] As a physician, you play a leadership role in guiding your patients’ health and well-being.
They look to you, not only for medical diagnosis and treatment, but also for your knowledge
and expertise on a wide range of topics.
Dietary supplement use is one of these important topics.
Your patients may take dietary supplements for a variety of reasons, whether recommended
by you or on their own.
There are important facts your patients need to know before taking dietary supplements.
Yes, supplements can have benefits, but they may also come with risks.
For example, they can cause adverse reactions or interact with medications and other supplements.
And many of your patients probably don’t realize that, unlike prescription drugs, dietary
supplements are not approved by the government for safety or efficacy.
The goal of this continuing medical education video is to give you a deeper understanding
of dietary supplements.
This includes how they are defined, regulated, and labeled, what types of claims are permitted,
potential interactions, adverse events, and how to report them.
At the conclusion of the video, we will view a conversation between a healthcare professional
and patient to help you learn ways to effectively communicate with your patients
about dietary supplements.
This video is being made available to you through a collaboration between the U.S. Food
and Drug Administration and the American Medical Association.
Also provided are companion educational materials that you and your office staff can share with
patients.
Let’s begin with the definition of a dietary supplement.
A dietary supplement is a product that is ingested—specifically, it must be swallowed—and
is intended to supplement the diet.
It cannot be marketed as a replacement for a meal or item of the diet.
Dietary supplements contain ingredients such as vitamins, minerals, herbs, botanical extracts
and constituents, amino acids, enzymes, and live microbials (commonly referred to as “probiotics”).
It is important to note that not every product marketed as a dietary supplement meets this
definition.
Dietary supplements come in a variety of forms such as tablets, capsules, softgels, gel caps,
liquids, gummies, powders, and bars.
FDA’s laws and regulations that cover dietary supplements are different than those covering
conventional foods, over-the-counter drugs, and prescription drugs.
For example, unlike with prescription drugs, FDA does not have the authority to approve
dietary supplements for safety or efficacy before they are marketed.
In 1994, the Dietary Supplement Health and Education Act—or DSHEA (De Shay)—was enacted.
This law defined dietary supplements and laid out FDA’s regulatory authority.
At that time, dietary supplements were a four-billion dollar industry, with about four thousand
unique products available to consumers.
Today, the industry is estimated to be ten times that size in sales, with more than 50,000—and
possibly more than 80,000—dietary supplement products available to consumers.
Some of the most commonly used supplements on the market today include:
Multivitamins, vitamin D, fish oil, vitamin C, calcium, and vitamin B12.
People of all ages take dietary supplements for a variety of reasons.
Some dietary supplements can help improve or maintain overall health and provide adequate
amounts of essential nutrients that the body needs to function.
But dietary supplements are not intended to be a substitute for conventional food or meals.
Conventional food should always be the primary source of nutrients, and a healthy diet starts
with eating a variety of foods.
Now let’s review how dietary supplements are regulated by FDA.
DSHEA (De Shay) defined dietary supplements as a category of foods.
So, they must comply with requirements that apply to food as well as the dietary supplement-specific
requirements.
For the most part, FDA’s role in regulating dietary supplements begins after the product
enters the marketplace.
Unlike prescription drugs, FDA does not have the authority to approve dietary supplements
or their labeling before products are introduced to the market.
Under the framework laid out in DSHEA, the manufacturers and marketers of dietary supplements
are responsible for ensuring their products are safe and lawful and that claims made about
their products are truthful and substantiated.
Companies can introduce new dietary supplements to the market without receiving approval from
FDA.
In fact, they often can introduce dietary supplements to the market without even notifying
FDA.
Ok, so you might be wondering…if FDA doesn’t approve dietary supplements, how exactly do
they regulate dietary supplements to make sure they are safe for consumers like your
patients?
FDA has product manufacturing and labeling requirements in place for dietary supplements.
FDA also receives and reviews premarket safety submissions in some limited circumstances
and submissions regarding certain dietary supplement labeling claims.
In addition, FDA monitors the compliance of dietary supplements through a variety of surveillance
activities, including inspecting manufacturing facilities for product quality and labeling,
including claims, as well as monitoring adverse event reports and product complaints to identify
products that may be unsafe.
If FDA finds that a product is potentially unsafe or not otherwise in compliance with
the law, the Agency can work with the manufacturer to bring the product into compliance or, if
needed, it can remove adulterated or misbranded products from the market.
In general, “adulterated” means that the product contains contaminants or is otherwise
unsafe; and “misbranded” means that the labeling fails to meet applicable requirements.
Even with this authority, however, the ever-expanding number of supplements presents a challenge
for FDA as it oversees the dietary supplement market.
For more detailed information about how FDA regulates dietary supplements,
visit the FDA website.
[On-screen] Dietary Supplement Labeling
As we discussed, it is important that your patients understand that FDA does not approve
dietary supplements or product labeling.
Companies that manufacture or market dietary supplements are responsible for ensuring that
product labels are truthful and not misleading.
FDA requires that certain information appear on supplement labels—this includes a statement
on the front of the product identifying it as a “dietary supplement” or similar term
(for example, “vitamin supplement”).
Dietary supplements are also required to have a Supplement Facts label that lists the serving
size, the number of servings per container, each dietary ingredient in the product, and
the amount of certain ingredients per serving.
The label also lists information about dietary ingredients contained within proprietary blends
and other ingredients, such as fillers, binders, preservatives, sweeteners, and flavorings
in descending order by weight.
[On-screen] Dietary Supplement Claims"
[Host] It is also important to understand that dietary supplements are not intended to treat, diagnose,
prevent, mitigate, or cure diseases.
Products bearing such claims are classified as “drugs.”
For example, any product, even if marketed as a dietary supplement, that bears a claim
such as “treats heart disease,” “cures cancer,” or “prevents Alzheimer’s disease,”
is a drug and must meet all the requirements that apply to drugs.
Federal law permits dietary supplement manufacturers and marketers to make certain claims that
describe how the product affects either the structure or the function of the human body.
These claims are often referred to as structure/function claims.
Manufacturers can make structure/function claims as long as they can, among other requirements,
substantiate that the claims are truthful and not misleading.
If the manufacturer chooses to make statements about the effects of the product on the structure
or function of the human body, they must also include a disclaimer on the product labeling
that reads: “This statement has not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease.”
Let’s talk a little more about structure/function claims.
A structure/function claim may describe how a particular nutrient or dietary ingredient
affects the normal structure or function of the human body—for example,
“calcium builds strong bones.”
Claims may also describe how a nutrient or dietary ingredient acts to maintain the structure
or function of the body.
For example, “fiber maintains bowel regularity.”
Or “antioxidants maintain cell integrity.”
Manufacturers and marketers are required to notify FDA within 30 days after they first
market a product with a structure/function claim.
They are also responsible for ensuring the accuracy and truthfulness of the claim.
FDA reviews a claim to ensure that it is not a claim that renders the product a drug.
FDA generally does not independently verify whether a claim is adequately substantiated.
In addition, FDA and the Federal Trade Commission, or FTC, often work together to regulate dietary
supplement claims.
FTC regulates the advertising of dietary supplements and specifically looks at the truth and accuracy
of claims made in dietary supplement advertising and marketing.
This coordinated effort between FDA and FTC helps ensure truth in advertising when it
comes to dietary supplements.
[On-screen] Dietary Supplements: What Every Patient Should Know
Thank you for watching Part 1.
Please continue to Part 2.