Dietary Supplements

What is the definition of a dietary supplement?

The Dietary Supplement Health and Education Act (DSHEA) of 1994 gave Congress the authority to define “dietary supplement.” A dietary supplement is a product meant for ingestion that contains a “dietary component” designed to enhance the diet, among other things. Vitamins and minerals, herbs and other botanicals, amino acids, “dietary substances” that are part of the food supply, such as enzymes and live microbially (commonly referred to as “probiotics”), and concentrates, metabolites, constituents, extracts, or combinations of any dietary ingredient from the preceding categories are all included under the term “dietary ingredient.” Pills, tablets, capsules, gummies, soft gels, liquids, and powders are all examples of dietary supplements. They can also take the shape of a traditional food category, such as teas or bars, but only if the product isn’t advertised as a conventional food or as the “single component of a meal or diet.”

A product must also be labeled as a dietary supplement to be considered one; that is, the product label must include the word “dietary supplement” or a similar term (e.g., “iron supplement” or “herbal supplement“). Unless the product satisfies the definition of a drug, DSHEA classifies dietary supplements in a separate category under the broad heading of “foods” (e.g., because it is labeled to treat or mitigate a disease).

Unless the article was previously marketed as a dietary supplement or as a food, 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 are generally excluded from the dietary supplement category. The exclusion from the dietary supplement definition applies only if “substantial clinical investigations” have been begun and such studies have been made public in the case of goods designated for clinical study under an IND.

In a dietary supplement, what is a “new dietary ingredient”?
The phrases “dietary ingredient” and “new dietary ingredient” were defined in the Dietary Supplement Health and Education Act (DSHEA) of 1994. An ingredient in a dietary supplement must be one of the following to be considered a “dietary ingredient”:

What is the F.D.A.’s role in regulating dietary supplements vs. the obligation of the producer to sell them?
The Dietary Supplement Health and Education Act (DSHEA) created a new regulatory framework for dietary supplements by amending the Federal Food, Drug, and Cosmetic Act (FD&C Act). The F.D.A. does not have the jurisdiction to approve nutritional supplements before their marketing under the DSHEA. In general, a company does not have to provide F.D.A. with the evidence it uses to substantiate safety before or after it markets its products; however, dietary supplements containing a new dietary ingredient that is not present in the food supply as an article used for food in a form that has not been chemically altered are exempt. The manufacturer or distributor must notify F.D.A. at least 75 days before introducing such a dietary supplement into interstate commerce or delivering it for introduction into interstate commerce, with the information on which the firm has concluded that the NDI-containing nutritional supplement will reasonably be expected to be safe. Furthermore, the F.D.A.’s laws require those who manufacture, package or keep dietary supplements to adhere to current good manufacturing practices, which assist assure the identification, purity, quality, strength, and composition of the accessories. Before use, dietary supplement claims and other labeling are normally not approved by the F.D.A…

A company is accountable under the FD&C Act for ensuring that the dietary supplements it makes or distributes are not adulterated, misbranded, or otherwise illegal. Suppose a manufacturer or distributor makes a structure/function claim (a claim about effects on a human body structure or function), a benefit claim related to a classic nutrient deficiency disease, or a share of general well-being in labeling a dietary supplement. In that case, the company must prove that the claim is true and not misleading. Before beginning operations, facilities that manufacture, process, pack, or hold dietary supplements or dietary ingredients for consumption in the United States must register with F.D.A., as mandated by the Public Health Security and Bioterrorism Preparedness and Response Act 2002 and its implementing regulations.

The Food and Drug Administration (F.D.A.) implements the rules and regulations that regulate dietary supplements. Inspections, market monitoring, examination of nutritional supplements and nutritional ingredients offered for import, and review of N.D.I. notifications and other regulatory submissions for dietary supplements (e.g., postmarket reports 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)) are all used to identify violations. We also look at consumer reports and complaints and reports and concerns from health care professionals, other regulatory authorities, and the industry.

When does a manufacturer or distributor have to tell the F.D.A. about a dietary supplement they want to sell in the U.S.?
If a manufacturer or distributor intends to market a dietary supplement in the United States that contains a “new dietary ingredient,” the Dietary Supplement Health and Education Act (DSHEA) requires them to notify F.D.A. in advance and submit safety information unless the new dietary ingredient is present in the food supply as an article used for food in a form that has not been chemically altered. The F.D.A. must receive the notification at least 75 days before the product is introduced into interstate commerce or delivered. The notice must include the safety information on which the notifier has based its conclusion that the new dietary ingredient will be reasonably expected to be safe when used under the conditions recommended or suggested in the dietary supplement labeling, as well as information about the new dietary ingredient and the dietary supplement in which it will be marketed.

What information must a dietary supplement’s manufacturer provide on the label?
The name of the product and a statement that it is a “dietary supplement” or equivalent term replacing “dietary” with the name or type of dietary ingredient in the product (e.g., “iron supplement” or “herbal supplement”); the manufacturer, packer, or distributor’s name and place of business; nutrition labeling in the form of a “Supplement Facts” panel (except for some small volume products or those produced by eligible Except for dietary components that are part of a proprietary blend, the Supplement Facts panel must include the serving size and the number of servings per container, disclose each dietary ingredient in the product, and provide information on the quantity of the dietary ingredient per serving. The portion per serving must be indicated as a numeric amount by weight, a percentage of the Daily Value, or both, depending on the kind of component. Finally, dietary supplement labels must provide a domestic address or phone number for reporting significant adverse effects to the manufacturer, packer, or distributor stated on the label.

Is it necessary for all components to be listed on a dietary supplement’s label?
Yes, components that aren’t specified in the “Supplement Facts” panel must be listed in the “Other Ingredients” section. If not stated in the “Supplement Facts” panel, the sorts of components listed there might include the sources of dietary nutrients (e.g., rose hips as a source of vitamin C), other food ingredients (e.g., water and sugar), food additives, and color additives. Other substances often listed in the “Other Ingredients” section include gelatin, starch, stabilizers, preservatives, and flavors.

Are dietary supplement serving sizes defined, or are there limits to how much of a dietary component may be in a single dose?
There are no laws or regulations that limit the serving size of a dietary supplement or the amount of a dietary ingredient that can be in a serving of a dietary supplement, aside from the manufacturer’s responsibility to meet the safety standards and labeling requirements for dietary supplements, as well as to comply with current good manufacturing regulations. The manufacturer makes this decision, which does not require F.D.A. clearance.

Where can I learn more about a particular dietary supplement?
Because the F.D.A. does not review dietary supplements before they are sold, it is frequently unaware of new product launches. As a result, we cannot maintain a comprehensive list of all nutritional supplements available in the United States. If you need more information on a certain dietary supplement than what’s on the label, we recommend contacting the product’s manufacturer directly. The manufacturer’s or distributor’s name and address may be found on the nutritional supplement’s label.

Who is responsible for verifying that a product satisfies the dietary supplement safety standards?
Because the legislation forbids the distribution and sale of contaminated dietary supplements, manufacturers’ and distributors’ obligation is to ensure that their products fulfill the dietary supplement safety criteria. When manufacturers and distributors fail to meet their commitments and contaminated dietary supplements enter the market, the F.D.A. can enforce the law in order to safeguard consumers. Because, unlike medicines, which must be proven safe and effective for their intended purpose before marketing, there are no provisions in the law for F.D.A. to approve dietary supplements for safety before they reach the customer, F.D.A. is restricted to postmarket regulation. Manufacturers and distributors of nutritional supplements, on the other hand, are required to keep track of, investigate, and report any major adverse events linked with the use of their products to the F.D.A. These reports, as well as any other adverse event information provided by health care professionals or consumers, are analyzed by the F.D.A. in order to uncover early warning signs that a product may pose a danger to consumers’ safety. How to Report a Problem with Dietary Supplements has further information on reporting adverse events connected with the use of dietary supplements.

How can customers learn more about the safety of dietary supplements and other concerns?
Before acquiring health-related items, it is critical to be well-informed. Before using a dietary supplement, customers should check with a health care practitioner, according to the F.D.A. Consumers should read the label of any dietary supplement they intend to use carefully. F.D.A. has created additional instructional resources to assist people in their quest for better information. Please go to Dietary Supplement Information for Consumers.

What is the F.D.A.’s role in dietary supplement regulation?
Because dietary supplements fall under the “umbrella” of foods, the F.D.A.’s Center for Food Safety and Applied Nutrition (CFSAN) is in charge of overseeing these items. Inspecting dietary supplement manufacturing facilities, reviewing new dietary ingredient (N.D.I.) notifications and other regulatory submissions for dietary supplements, investigating complaints, monitoring the dietary supplement marketplace, examining dietary supplements and dietary ingredients offered for import to determine whether they meet U.S. requirements, and reviewing adverse event reports are all part of F.D.A.’s role in regulating dietary supplements. The F.D.A., on the other hand, is not required by law to approve dietary supplements or their labeling, albeit some types of claims used in dietary supplement labeling do require premarket assessment and approval (e.g., health claims).

Is the substance of dietary supplements examined by the F.D.A. on a regular basis?
No. Because the F.D.A. has limited resources to investigate the composition of food items, including dietary supplements, it prioritizes public health crises and goods that may have caused harm or sickness. Priority is given to items that are suspected of being contaminated, fraudulent, or otherwise illegal. The remaining resources are utilized to evaluate product samples gathered during manufacturing company inspections or plucked from store shelves as part of F.D.A.’s normal market surveillance. Dietary supplements are not tested by the F.D.A. before they are offered to consumers. Consumers can request an examination of a product’s composition from the maker or a commercial laboratory.