New changes are coming to the way dietary supplements will be regulated. The Food and Drug Administration (FDA) works hard everyday to make sure that the supplements humans consume are safe (1).
For many years these regulations were enforced by The Dietary Supplement Health and Education Act (DSHEA) of 1994, which was an amendment of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (2,3). However, a recent report reveals that due to the significant growth of the dietary supplement industry over the past two decades, modernized dietary supplement regulations are needed (4).
These changes could help penalize any supplements that may be making false claims and in turn misleading consumers. By stopping such products from reaching your medicine cabinet, and making sure supplements contain what they claim, the consumer can be protected by potential harmful side effects and can make more educated choices.
Let’s learn a bit more about the history of dietary supplement regulation, changes that are coming soon, and how they will affect the consumer.
What Does the FDA Do?
The FDA is an agency of the federal government within the Department of Health and Human Services that is responsible for overseeing the safety, regulation, and security of the foods and medicines available in the marketplace (1,4).
The FDA’s functions include ensuring the safety, efficacy, and security of medical devices, any drugs that plan to be consumed by animals or humans, regulating tobacco distribution, as well as ensuring the safety of the nation’s food supply and cosmetics.
Also, as of March 31, 2019, the FDA is reorganizing in order to modernize its structure (4). The agency is doing this to help advance its mission to protect and promote public health as well as to meet the challenges of the “rapid innovation across the industries regulated by the FDA.”
What is Considered a Dietary Supplement?
As defined by the FDA, a dietary ingredient as a vitamin, herb, mineral, botanical, amino acid, or other compound used by consumers to improve their total dietary intake, among other things (5).
Unlike medicines, it’s important to remember that supplements “are not intended to treat, diagnose, prevent, or cure diseases.”
When you think of supplements, you may envision tablets and capsules lined up in alphabetical order in the pharmacy section of the grocery store or pharmacy. However, dietary supplements can also come in soft gels, gel caps, powders, liquids, and most recently, gummy form.
You may notice when you purchase such supplements that many claims may be made such as the ability of the supplement to produce weight loss, energy, improved bone or heart health, among other claims. The regulation of such claims is where the FDA comes in to help protect the consumer.
The Origin of Dietary Supplement Regulation
In 1994, the DSHEA was created as an amendment of the FD&C Act to help define and better regulate the distribution and sale of dietary supplements that would become available to the public (2,6). It helped reaffirm the status of dietary supplements as a category of food yet prohibited companies from regulating ingredients of dietary supplements as food additives (6).
However, any supplement ingredients marketed in the United States before this act was created, around October 15, 1994, were grandfathered into the system (2,6). That basically means that they were considered safe for consumer use and only new supplement ingredients had to submit paperwork to the FDA to support claims that their ingredient was “reasonably expected to be safe (6).” This information would have to be submitted to the FDA 75 days before a product was scheduled to enter the marketplace.
The DSHEA would help the FDA to remove any products from the market that they deemed unsafe (6). A product would be deemed unsafe if it is considered to present an immediate health concern or if a product is considered to pose an “unacceptable risk of illness or injury.”
Functions of the DSHEA
Along with protecting the consumer from such harmful products, the DSHEA was also created to help protect the consumer from being duped by false or misleading claims (2). This part of the DSHEA helps to ensure that labels of dietary supplements contain information that has been proven by research not to be false or misleading. And information may be allowed if the benefits claimed about a certain dietary ingredient have been shown to benefit health and wellness through evidence-based research.
Not to mention that such dietary supplements must include in bold-faced print on the label that:
“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.”
Along with protecting the consumer from false claims, the DSHEA also protects the consumer from receiving a product that contains ingredients or contains quantities of ingredients that are not properly listed on the label (2).
This part of the DSHEA ensures that the consumer is receiving the ingredients that are listed on the label in the amounts listed. The FDA uses this portion of DSHEA to make sure that companies cannot get away with selling a diluted product, or a product full of additives that have not been regulated.
Changes to Come in Dietary Supplement Regulation
Although the regulations listed in the 1994 DSHEA seem extensive, the FDA Commissioner, Scott Gottlieb, M.D. reports that the dietary supplement industry has grown at such a rapid pace since the DSHEA was enacted that it is due for updates (7).
He reports that when the DSHEA was created, the dietary supplement industry was a $4 billion industry that comprised of about 4,000 unique products. Currently, this number has risen to a $40 billion industry with more than 50,000 unique products.
With such a huge growth in the dietary supplement industry, it’s inevitable that some supplements may fall through the cracks and get into the hands of consumers. With about 75-percent of the American population using a daily supplement, up from 65-percent in 2009, it’s vital to have proper regulations in place to protect the safety of consumers from potentially harmful dietary supplements (8).
The FDA has already started the process of weeding out potentially harmful products by sending out 12 warning letters and five online advisory letters to companies whose products were making harmful claims that they could prevent, treat, or cure diseases like diabetes, cancer, and Alzheimer’s disease.
Any product that makes such claims must have FDA approval to prove they are effective before they can be sold for medical use.
In addition to this process, some of the major changes taking place over the next several months or so in the regulation of dietary supplements include:
- A Dietary Supplement Working Group that will be established at the FDA to help examine the organizational structures of the FDA as well as practices and processes within the agency to help identify opportunities for change and improvement.
- The development of a rapid response tool that will alert the public as soon as a potentially harmful dietary supplement has been identified. This will help prevent consumers from purchasing and/or using such products as well as inform responsible industry participants so they can avoid making or selling such products.
- Preparing new dietary ingredient (NDI) notifications that will better ensure that the FDA is thoroughly reviewing the safety of such ingredients.
- The creation of the Botanical Safety Consortium, which is a public-private partnership that will unite scientific minds from across the nation to look at ways to further improve the safety evaluation of botanical ingredients and mixtures in dietary supplements. This may include finding alternatives to animal testing or looking at new ways to use innovative toxicology tools.
- Developing new enforcement strategies to properly penalize companies that produce products claiming to be dietary supplements that may contain illegal ingredients.
- Engaging a public dialogue to help discuss ways the DSHEA could be improved upon.
The FDA Commissioner states that his major goals of this dietary supplement regulation makeover of sorts are to:
- Ensure safety and protect consumers from harmful products
- Maintaining product integrity by ensuring that products contain what they say they contain and nothing more or less
- Informed decision-making
Although this may not be headline news on every local news outlet, that doesn’t mean that this isn’t an important piece of history. Because of the ever-growing use of dietary supplements by the public, continuous updating of laws and regulations regarding such supplements is vital to the safety and health of the consumers of the United States.
Over the next few months, and likely for years to come, the FDA will be working hard to ensure that the supplements you see advertised and sitting on grocery store and pharmacy shelves are safe for consumption.
Although the United States has some of the safest supplements in the world due to the FDA and acts like the DSHEA, it’s still important for the consumer themselves to be aware of the supplements they purchase. When walking down the supplement aisle, be diligent in reading the label and do any research ahead of time to ensure the product you are planning on purchasing is going to benefit you and not produce any harmful results.