800-547-9812
800-547-9812
More than 57 percent of Americans take dietary supplements on a regular basis. The older people get, the more likely they are to take them. If you, like many Americans, take herbal supplements or other vitamins and minerals, you want to know you are getting high-quality products.
There are a lot of myths about supplement regulation. Most people know that supplements are not drug products. But you may not be familiar with the FDA regulations that do exist.
In this article, we will cover the information that supplement users need to know, including what health claims can be made and how companies are allowed to advertise their products.
Dietary supplements are products that are intended to fill in gaps in a diet. They do not replace meals and so they differ from food products.
Dietary supplements include:
Supplements come in many forms, such as:
According to the CDC, the most popular types of dietary supplement products are multivitamin-minerals, vitamin D, calcium, and omega-3 fatty acids. Herbal supplements, sometimes called botanicals, like ginkgo and ginseng are also popular.
Supplements can provide nutrients that support optimal function.† They also have the potential to cause side effects and interact with other over-the-counter medications, prescriptions, or even other supplements. Always work with your health care provider to determine what is right for you. This can help avoid adverse events.
The U.S. Food and Drug Administration (FDA) regulates the dietary supplements industry. It is also regulated by the Federal Trade Commission (FTC) and by state-level government agencies.
Congress gave the FDA regulatory authority over the supplements industry when they passed the Dietary Supplement Health and Education Act of 1994. This law is also known as DSHEA.
The FDA regulates both individual ingredients and finished dietary supplement products. They can remove products that are misbranded or that make false claims. The FDA and FTC also investigate consumer complaints of contamination or other harms from supplements.
Dietary supplement manufacturers must adhere to a strict set of requirements and laws when it comes to labeling, advertising, and marketing their products.
Dietary supplements are considered food products under DSHEA regulations. They are described as a “product taken by mouth that contains a dietary ingredient intended to supplement the diet.” (2) Supplements are therefore not in the same category as pharmaceutical medications.
Consumers sometimes mistakenly assume the FDA ensures all supplements are safe. As supplements are food products, not drugs, the FDA does not require clinical trials or safety testing before supplements come to market. Due to this difference, supplement companies can not make any claims about their products being able to treat, diagnose, prevent, or cure diseases.
If you have ever bought supplements or looked at a product label, you have likely seen this disclaimer:
DHSEA does not require that supplements undergo trials to determine their efficacy or how well they work. It does require that supplement companies conduct premarket testing to assess safety before they can be legally sold. Manufacturers must also provide evidence that the claims on their products are accurate.
The FTC regulates dietary supplement advertising. The laws require that all advertising claims must be truthful, backed by scientific evidence, and not misleading.
Most people buy supplements for a specific reason. It may be preventive, like taking calcium to support bone health. It may be vitamin C to support healthy immune system function.
There are many reasons to take supplements. Sometimes doctors will recommend them to help with health concerns. Dietary supplement companies are not allowed to suggest that any supplements can prevent illness, help you get better faster, or cure any ongoing health problems. All dietary supplement advertising must be phrased in the context of supporting an already healthy or normal state of function.
Dietary supplements can make some structure/function claims if they are backed by evidence. (3) These structure/function statements are followed with an asterisk or other symbol denoting the FDA disclaimer.
The following are allowable examples as long as they are applicable to the product they are referring to:
Structure/function claims must not imply that the product treats or prevents disease. Supplement companies must notify the FDA of their product claims within 30 days of marketing the item. (4) This helps assure that the structure/function wording is supported by research.
While most of the supplement industry does follow the FDA’s regulations, it is important to do your research on specific brands. New supplement companies without a history of FDA compliance can sometimes rapidly release new products that are not supported by evidence and may not be safe. These products are usually removed by the FDA eventually, once the violations are discovered. But consumers can still be harmed in the process if they purchase from disreputable companies.
In some cases, supplement companies may release new dietary ingredients or new drugs that have not undergone proper testing or approval. In other cases, companies may make inappropriate claims about a supplement’s ability to treat, cure, or prevent disease. (5)
When you are shopping for supplements, there are some simple steps you can take to vet your products. This way you can feel confident that you are getting legitimate products that are compliant with FDA safety regulations and FTC marketing rules.
Read ingredients on the supplement facts label. Also look at the other ingredients. If you find ingredients you’ve never heard of on the back of a supplement label, look them up to understand what you are going to consume.
There are many ways that supplement companies can make indirect claims. They may have celebrities promote them. Social media influencers may offer discount codes. They may feature success stories that may or may not be typical for results.
Under federal laws, supplement companies must be able to back up all of their claims. But this does not mean that all wording used is straightforward. If something sounds too good to be true, do not take a celebrity or influencer’s word for it. Talk to your health care provider if you have questions and do more research into the supplement brand. (6)
Good manufacturing practices (GMPs) are guidelines for procedures and documentation of the manufacturing of nutritional supplements.
Supplement companies that are registered for cGMP (Current Good Manufacturing Practices) have strict qualification processes for sourced raw ingredients.† (7)This means that when each ingredient is received, it is tested to verify that its identity and potency are correct and not contaminated.
GMPs ensure that a product has the identity, strength, composition, quality, and purity that match the product’s label. Many supplement makers will post GMP certificates on their websites or provide one when asked.
NSF International is an independent organization that registers supplement makers as being GMP compliant. (8) Look for the NSF logo on the website of your favorite supplement brand to increase your confidence that the product is made in a GMP registered facility.
Most supplement companies have clearly stated money-back guarantees or return policies for their products. They will also have clear contact information so that consumers can ask questions and receive information on a timely basis.
Dietary supplement labels are required to have the name and location information of the manufacturer or distributor. If this information is missing, the product is likely not following other important regulations either.
Although supplements are not held to the same standard as pharmaceutical drugs, they are regulated strictly by the FDA. They are just not FDA approvedfor how they will work for you. This is why you want to only purchase supplements from companies that are transparent about their internal manufacturing processes.†
At Seeking Health, we go above and beyond to be a company you can trust. We take your health very seriously. We test our ingredients and products in multiple ways to deliver the highest quality formulas.†
Whether you purchase Seeking Health supplements or not, make sure that you take the time to evaluate supplement brands for good manufacturing practices, quality, and adherence to safety regulations. If claims coming from supplements sound too good to be true, they probably are.
Leave a comment