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FDA’s Regulation of Dietary Supplements with Dr. Cara Welch

Q&A with FDA Podcast | Transcript

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Dr. Roach: Welcome to “Q&A with FDA” from the FDA’s Division of Drug Information where we aim to answer some of the most frequently asked questions that we’ve received from the public.

My name is Dr. Sara Roach, and today we’ll be discussing dietary supplements. The dietary supplement market is currently worth more than 60 billion dollars, with as many as 100,000 different products available to consumers. Approximately 75% of Americans take a dietary supplement.

At FDA, we often receive questions from the public about dietary supplements. Today we are joined by Dr. Cara Welch, Director of FDA’s Office of Dietary Supplement Programs in the Center for Food Safety and Applied Nutrition. Dr. Welch directs the office responsible for setting the policies and programs for FDA’s oversight of dietary supplements. In today’s episode, she will be discussing dietary supplements, how FDA regulates them, the benefits associated with the use of these products, as well as the potential risks that consumers and health care professionals should consider prior to their use. Welcome, Dr. Welch, and thank you for speaking with us today!

Dr. Welch: Thank you for inviting me.

Dr. Roach: Let’s start with the basics. Can you explain to our audience, what exactly are dietary supplements?

Dr. Welch: Sure. Dietary supplements are vitamins, minerals, botanicals, probiotics, and similar products that consumers take to supplement their diet. It’s often to support or maintain a healthy lifestyle. Dietary supplements are sold in a variety of forms, including pills, tablets, but also liquids, gummies, and powders. Importantly, they have to be ingested, or swallowed, so a topical or inhaled product is not a dietary supplement. Additionally, they are not meant to be a substitute for meals or take the place of conventional foods, which should always be the primary source of nutrients.

Dr. Roach: And how are dietary supplements regulated? They don’t have the same requirements as drugs, but can you walk through FDA’s oversight of these products?

Dr. Welch: You’re correct, dietary supplements do not have the same requirements as drugs. In fact, the law that established FDA’s authority for dietary supplements – the Dietary Supplement Health and Education Act of 1994 or DSHEA – defined dietary supplements as a category of foods, so that is the foundation of how FDA regulates supplements. FDA does not approve dietary supplements or their product labeling before they are sold to the public. In fact, most products can be lawfully brought to the market without FDA even knowing. Companies that manufacture or market dietary supplements are responsible for ensuring that their products are safe and that label claims are truthful and substantiated. Some dietary supplements are required to have a safety submission, specifically for certain new ingredients. They have to have that on file with the FDA at least 75 days before marketing their product.

Dr. Roach: It seems that most of FDA’s role in regulating dietary supplements comes into play after a product is on the market.

Dr. Welch: Yes. We monitor the marketplace and examine dietary supplements, for example, through product testing or as products are imported into the country. FDA inspects manufacturing facilities to verify that companies are meeting the manufacturing and labeling requirements. We review the premarket safety notifications for certain new dietary ingredients and other regulatory submissions for dietary supplements. We also review and investigate adverse event reports and product complaints received from industry, healthcare professionals, and consumers. If the FDA determines that a dietary supplement is unsafe or otherwise unlawful, the agency can take action as needed, based on public health priorities and available resources. Sometimes this action involves working with companies to ensure their dietary supplements are safe and properly manufactured or labeled, but it could also include removing products from the market, if needed.

Dr. Roach: What are some of the challenges FDA faces in its efforts to keep unsafe supplements off the market?

Dr. Welch: So as I just mentioned, FDA has no systematic way of knowing when new dietary supplements are introduced to the market or what they contain. Because of this, we are often at a disadvantage to identify unsafe or otherwise unlawful supplements. To address this problem, FDA has supported the idea of a legislative change to require dietary supplements to be listed with FDA, including the brand, product name, the name and amount of each ingredient. We believe this new requirement would help to modernize our regulatory approach by giving the agency visibility into the entire dietary supplement marketplace. Having this visibility would allow FDA to gauge the breadth of the marketplace and identify supplements with particular ingredients more quickly in order to take action against dangerous or illegal products.

Dr. Roach: Dr. Welch, the Federal Food Drug & Cosmetic Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” So, for example, products claiming to treat heart disease or cure cancer are drugs. How is this different from claims that dietary supplement can make?

Dr. Welch: I’m glad you asked this because there are a number of health-related claims that dietary supplements can make, but they are not permitted to make claims to diagnose, treat, or cure diseases.

Instead, supplements are often marketed for purposes such as maintaining or improving health. The law permits certain claims that describe how dietary supplements affect the structure or the function of the human body as well as general well-being claims. The statements like “calcium builds strong bones” or “fiber maintains bowel regularity” are a couple examples of appropriate structure/function claims. If a product is making structure/function claims, the company must have information to support the claim is truthful and the product labeling must include a disclaimer stating that the statement has not been evaluated by FDA and the product is not intended to diagnose, treat, cure, or prevent any disease.

Dr. Roach: So, if a dietary supplement is making a claim, explicitly or implicitly, for the treatment, prevention, or cure of a disease, the product would be subject to regulation as a drug. Knowing this, consumers should not be looking to dietary supplements to treat conditions. Can you talk a bit more about why consumers would take dietary supplements? That is, what are the benefits of taking dietary supplements?

Dr. Welch: Dietary supplements can help consumers improve or maintain their overall health and support a healthy lifestyle. Some supplements can also help consumers meet their daily requirements of essential nutrients. For example, calcium and vitamin D can help someone who doesn’t get enough of these nutrients from their diet, or a consumer could use a fiber supplement to boost their fiber intake or a protein supplement to increase their protein. That said, even though dietary supplements can be beneficial, they should not take the place of the variety of foods that are important for a healthy diet.

Dr. Roach: What are some of the potential risks associated with taking dietary supplements?

Dr. Welch: Dietary supplements may contain ingredients that can have strong effects in the body – even if the ingredients are natural or plant-derived, they can be active in the body. And problems can occur if consumers take too much of a supplement, combine them with other dietary supplements or medications, or take supplements instead of prescribed medications. Some dietary supplements can interact with prescription or over-the-counter medications by altering their absorption, metabolism, or excretion – this could cause the medication to be more or less active than expected. Depending on the patient, these interactions could lead to dangerous or even life-threatening effects.

Dr. Roach: What can consumers do to make sure they are staying safe while taking dietary supplements?

Dr. Welch: FDA advises all consumers to consult with their doctor, pharmacist, or other health care professional before deciding to use a dietary supplement. Similarly, FDA strongly encourages health care professionals to have discussions with their patients about the supplements they are taking and to remind their patients to consult with them before taking any new products.

Dr. Roach: Patients should always read the medication guide, patient information sheet, or Drug Facts label that comes with their prescription drug, since it may contain information on whether a specific supplement affects the drug. Dr. Welch, what should consumers do if they experience an adverse event after taking a dietary supplement?

Dr. Welch: Consumers who think that a product might have caused an adverse event should immediately stop using the product, seek medical care, and submit a report to FDA using the Safety Reporting Portal that’s available on our website or through FDA’s MedWatch program. Although dietary supplement manufacturers are required to report serious adverse events to FDA, we strongly encourage consumers and health care professionals to voluntarily report adverse events or other labeling or product quality problems.

Dr. Roach: Speaking of product labeling and quality problems, how does FDA follow up on these types of reports?

Dr. Welch: I mentioned earlier that FDA inspects manufacturing facilities. We do this to ensure products are manufactured to the good manufacturing practices – or GMP – requirements. These requirements are in place to help ensure each product batch is consistently produced and that the finished product contains all the ingredients it’s labeled to contain, and nothing else.

If FDA’s inspection identifies problems, we try to work with companies to bring their manufacturing into compliance. If the problems remain, we can take more serious action to ultimately stop products from being manufactured or remove them from the market.

Dr. Roach: And what are some of the requirements for dietary supplement labels? Must all ingredients be declared on the label?

Dr. Welch: On the front of the label, dietary supplements are required to have a statement identifying it as a dietary supplement or a vitamin or herbal supplement. On the side panel, a dietary supplement must include the nutrition information and ingredient list with the title “Supplement Facts.” This Supplement Facts label, specifically, includes important information such as the serving size, the dietary ingredients in the product, and the amounts of those ingredients per serving. And yes, FDA regulations require dietary supplements to include all ingredients in the product; below that "Supplement Facts" label is where other ingredients, like flavors and colors and sweeteners, are listed. These other ingredients are listed in order of weight but the amount of each is not listed.

Dr. Roach: Finally, does FDA routinely test the contents of dietary supplements?

Dr. Welch: FDA does test some dietary supplements but we’re talking about a marketplace of over 100,000 products and we have limited resources to analyze the composition of dietary supplements. Because of this, we focus our resources first on public health emergencies and products that may have caused injury or illness. At that point, we prioritize products that we suspect to be adulterated, fraudulent, or otherwise in violation of the law. The remaining resources are used to analyze product samples collected during inspections of manufacturing facilities or pulled from store shelves as part of FDA’s routine monitoring of the marketplace. FDA does not test dietary supplements before they are sold to consumers. If consumers would like an analysis of a product’s content, they may contact the dietary supplement manufacturer or a commercial laboratory on their own.

Dr. Roach: This is all such great information! I really appreciate you taking the time to speak with us about dietary supplements today!

Thanks for listening to “Q&A with FDA.” The full podcast and transcript of this recording is available at fda.gov/QAwithFDA. If you have questions about this episode, or anything drug-related, email us at druginfo@fda.hhs.gov.


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