What is a dietary supplement?
Some people argue that the supplement industry is “unregulated” by the FDA, but in fact it is – how they’re regulated is where the controversy lies.
Congress defined the term “dietary supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product intended for ingestion that, among other requirements, contains a “dietary ingredient” intended to supplement the diet.
The term “dietary ingredient” includes vitamins and minerals; herbs and other botanicals; amino acids; “dietary substances” that are part of the food supply, such as enzymes and live microbials (commonly referred to as “probiotics”); and concentrates, metabolites, constituents, extracts, or combinations of any dietary ingredient from the preceding categories. Dietary supplements may be found in many forms, such as pills, tablets, capsules, gummies, softgels, liquids, and powders. They can also be in the same form as a conventional food category, such as teas or bars, but only if the product is not represented as a conventional food or as a “sole item of a meal or the diet.”
To be a dietary supplement, a product must also be labeled as a dietary supplement; that is, the product label must include the term “dietary supplement” or equivalent (e.g., “iron supplement” or “herbal supplement”). DSHEA places dietary supplements in a special category under the general umbrella of “foods,” unless the product meets the definition of a drug (e.g., because it is labeled to treat or mitigate a disease).
Generally, the dietary supplement category excludes articles approved as new drugs, licensed as biologics, or authorized for clinical investigation under an investigational new drug application (IND) that has gone into effect, unless the article was previously marketed as a dietary supplement or as a food. In the case of articles authorized for clinical investigation under an IND, the exclusion from the dietary supplement definition applies only if “substantial clinical investigations” have been instituted and the existence of such investigations has been made public.
What is a “new dietary ingredient” in a dietary supplement?
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the terms “dietary ingredient” and “new dietary ingredient.” To be a “dietary ingredient,” an ingredient in a dietary supplement must be one of the following:
- a vitamin
- a mineral
- an herb or other botanical
- an amino acid
- a dietary substance for use by man to supplement the diet by increasing the total dietary intake
- a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the other categories listed above.
A “new dietary ingredient” is an ingredient that meets the definition of a “dietary ingredient” and was not marketed in the United States before October 15, 1994.
How Are Supplements Regulated?
Supplements are not regulated like pharmaceutical drugs; they’re regulated as food. The FDA regulates the safety and efficacy of drugs sold in the United States. In order for a pharmaceutical company to introduce a new drug, it must go through a rigorous preapproval process or pre-market phase. During this pre-market phase, the FDA will review a manufacturers application to market and sell a drug. Once a drug is approved, it goes into the post-maket phase, where the FDA will continue oversight of the safety and efficacy of that drug, for the duration of its use.
Before a pharmaceutical company can launch a new drug, the FDA has to determine and conclude that the drug is safe and efficacious when indicated as a treatment for a specific medical condition. Launching a new drug, costs millions of dollars in clinical research beginning with animal studies. If the animal studies prove to be effective, they move onto human trials to develop and substantiate a pharmaceutical product. Once the drug is proven to have clinical benefit during several phases of human trials, it can then be submitted for FDA approval.
Supplements are not held to the same grueling standards as pharmaceuticals. In fact, supplements can go to market, without any safety, purity, and or quality testing by the FDA.
Prior to 1994, supplements the manufacturing process, quality assurance and control, and labeling of supplements were all closely monitored and regulated by the FDA. However, many people felt that the FDA was too restrictive in regulating dietary supplements. As a result, Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994. The new act placed dietary supplements in a special category of “foods” and defined a “dietary supplement” as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.
What is FDA’s role in regulating dietary supplements versus the manufacturer’s responsibility for marketing them?
The Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create a new regulatory framework for dietary supplements. Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed. Generally, a firm does not have to provide FDA with the evidence it relies on to substantiate safety before or after it markets its products; however, there is an exception for dietary supplements that contain a new dietary ingredient that is not present in the food supply as an article used for food in a form in which the food has not been chemically altered.
At least 75 days before introducing such a dietary supplement into interstate commerce or delivering it for introduction into interstate commerce, the manufacturer or distributor must submit a notification to FDA with the information on the basis of which the firm has concluded that the NDI-containing dietary supplement will reasonably be expected to be safe. In addition, FDA’s regulations require those who manufacture, package, or hold dietary supplements to follow current good manufacturing practices that help ensure the identity, purity, quality, strength, and composition of dietary supplements. FDA generally does not approve dietary supplement claims or other labeling before use.
Under the FD&C Act, a firm is responsible for ensuring that the dietary supplements it manufactures or distributes are not adulterated, misbranded, or otherwise in violation of federal law. If a manufacturer or distributor makes a structure/function claim (a claim about effects on a structure or function of the human body), a claim of a benefit related to a classical nutrient deficiency disease, or a claim of general well-being in the labeling of a dietary supplement, the firm must have substantiation that the claim is truthful and not misleading. Facilities that manufacture, process, pack, or hold dietary supplements or dietary ingredients for consumption in the United States must register with FDA, as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and implementing regulations, before beginning such operations.
FDA is responsible for enforcing the laws and regulations governing dietary supplements. To identify violations, the agency conducts inspections, monitors the marketplace, examines dietary supplements and dietary ingredients offered for import, and reviews NDI notifications and other regulatory submissions for dietary supplements (e.g., postmarket notifications of a structure/function claim or other claim made under section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)). We also investigate adverse event reports and complaints from consumers, health care professionals, other regulatory agencies, and industry.
Should I check with my doctor or health care provider before using a dietary supplement?
Yes. FDA advises consumers to talk to their doctor, pharmacist, or other health care professional before deciding to purchase or use a dietary supplement. For example, some supplements might interact with medicines or other supplements.
Please see Information for Consumers on Using Dietary Supplements for additional educational materials.
The Problem With The Supplement Industry
Although supplements can go to market without preapproval, the DHSEA does state that new dietary supplements must undergo premarket review to analyze safety data before it can be legally sold. Manufacturers must provide evidence to show that dietary supplements it produces are safe and that any product claims are proven and substantiated, nor false, or misleading. Because of this, supplement manufacturers are required to include “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease” on the label.
In 1994 the Nutrition Labeling and Education Act (NELA) was passed. NELA gives the FDA the ability to review and approve health claims for dietary supplements and foods. However, since the inception of NELA, it has only reviewed a few claims.
Even though the DHSEA requires new ingredients to be evaluated, prior to being sold, the FDA does not have the authority to stop it from going to market. Thousands of food additives and products have become part of our food system, because producers deem them “generally recognized as safe” (GRAS). Introduced in 1958 the GRAS loophole allows producers to take new ingredients to market without informing the FDA. Therefore, since DHSEA classified supplements as foods, the law allows any food products to go directly to market and carry unsubstantiated claims.
The problem with this of course, is that only after adverse effects have been reported, does the FDA have a substantiated claim to prove the product is unsafe. Most of the time, the FDA doesn’t even know a new ingredient is introduced in the market, until after the fact, when a report is acknowledged.
Since DHSEA was enacted in 1994, the supplement industry has grown from 4 billion, to now over 80 billion, according to the FDA. While most of the supplement industry does abide by the regulations, the huge growth has allowed a few bad apples to sell dangerous products with unsupported claims. However, this can be seen within any industry.
Although supplements are not subject to premarket approval, manufacturers must adhere to a number of federal regulations before a product goes to market. Further, supplement manufactures must have evidence that shows the ingredients they use in their supplements are generally safe if requested by the FDA. For this exact reason, most quality supplement manufacturers will employ a team of researchers, in charge of several quality control and quality assurance protocols, such as product education, product development, and assisting in clinical trials conducted by independent research teams at universities and clinical research sites. Legal teams are also employed to work in conjunction with marketing, in order to substantiate product claims, and adhere to FDA label requirements.
How To Find Supplements You Can Trust
As you know, supplements can be tricky. Even though there are technically regulated by the FDA, they are not held to the same scrutiny as pharmaceutical drugs. Therefore, it is the consumers responsibility to do research before purchasing a supplement to ensure its effectiveness.
Make sure to look for the following items before considering the use of a supplement
Step 1: Does the supplement contain proprietary blends?
If so, then do not purchase it, because you don’t know what the supplement really contains. Most pre workout and post workout products will contain proprietary blends, and underdose the ingredients you need to improve performance. If the supplement does not have enough of those ingredients, they will be ineffective.
Step 2: Are the ingredients in the supplement proven and clinically dosed?
Don’t fall for false and misleading marketing claims. Make sure the ingredients in the supplement are supported with evidence-based outcomes and contain the appropriate dose. Supplement manufacturers will use hype marketing around “the latest and greatest” new ingredients, which have no merit, and no research that proves they work.
Step 3: Does the company provide clinical evidence to support their product claims
If the supplement you’re interested in does provide clinical research, then simply conduct a google search and find the appropriate clinical dose used in clinical research before you purchase a product.
Step 4: Does the company provide a certificates of analysis of their products
A Certificate of Analysis is a document issued by the Quality Assurance Department that provides analysis of each product testing for contamination and foreign constituents as part of a quality control process. If you’re unsure of a product or specific ingredient in a supplement, contact the manufacturer and request a certificate of analysis.
Step 5: Does the company follow Certified Good Manufacturing Practices?
cGMP facilities are held liable for accurate representation and reporting of manufactured products, ensuring that they consistently meet the established specifications for identity, purity, strength, and composition and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under sections 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act” [referring to the Federal Food, Drug, and Cosmetic Act]
Takeaway
Although supplements are not held to the same standard as pharmaceutical drugs, they are regulated, just not FDA approved. As a consumer, it is crucial that you do your research prior to purchase. Dietary supplements DO NOT need FDA approval prior to marketing their products. Just because you see a supplement product on a store shelf does NOT mean it is safe or effective. Make sure the product contains proven ingredients, with the correct dose of each ingredient, otherwise the product will be ineffective despite manufacturer claims. At that point, you might as well just throw your money down the drain.
