Food supplements, or dietary supplements, are defined as “products taken by mouth that contain a “dietary ingredient”.
Food supplements are mainly regulated by the Dietary Supplement Health and Education Act 1994.
Pursuant to the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.
Dietary supplements are sold in many forms, such as tablets, capsules, powders, energy bars and liquids.
· There are general statutory and regulatory requirements applicable to all food and dietary supplement manufacturers.
· The FDCA places the burden on the manufacturer to ensure that only safe and properly labelled foods and dietary supplements are introduced or delivered for introduction into U.S. commerce.Administrative data
. Products that are found to be violative are considered “adulterated” and/or “misbranded” and could be subject to regulatory action by FDA, which could range from import detention, the issuance of a warning letter, seizure, injunction, civil penalties, and criminal prosecution.
. Imported products tend to have a higher enforcement risk since they can be detained upon import
· Food and dietary supplement manufacturers must be registered food facilities and prior notice of imported foods must be submitted to FDA before arrival.
· Dietary supplements marketed in the United States may consist of dietary ingredients and non-dietary ingredients
· As established by the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), “dietary ingredient” is defined as 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 total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above.
· Ingredients in dietary supplements that are not dietary ingredients are “non-dietary ingredients.” These include, for example, flavors, excipients, and fillers.
· Like conventional food ingredients, non-dietary ingredients used in dietary supplements must be either authorized for their intended use by a food additive regulation or otherwise considered generally recognized as safe (GRAS) among experts qualified by scientific training and experience, as described above.
. In contrast, dietary supplement dietary ingredients are specifically excluded from the food additive and GRAS provisions by statute and therefore are exempt from the above requirements. However, new dietary ingredients are subject to additional requirements, as discussed below.
New dietary ingredients
. A “new dietary ingredient” is defined by statute as a “dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.” While the language in the statute is broad, FDA has interpreted this narrowly to apply to a dietary ingredient that was not marketed in the United States as a dietary ingredient before October 15, 1994. Thus, if an ingredient was present in a food marketed in the United States before October 15, 1994, but that ingredient was used for some other purpose (e.g., as a color or as a processing aid), FDA would not consider evidence of that use sufficient to demonstrate that the ingredient is not a new dietary ingredient.
. It is common to refer to dietary ingredients that that were marketed in the US before October 15, 1994, as “old” dietary ingredients (“ODI”) or “grandfathered ingredients,” although these are not FDA-defined terms. There is no official FDA-recognized list of “old” dietary ingredients, but various trade organizations have compiled unofficial lists.
. There is also a list of prohibited plants. These are plants with a known toxic effect. They are prohibited even if they are included in the GRAS index.
. The law provides that a dietary supplement which contains a new dietary ingredient shall be deemed adulterated unless:
The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
An NDI notification is submitted to FDA at least 75 days before the dietary supplement is introduced into interstate commerce that provides the basis upon which the manufacturer has concluded that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of the dietary supplement.
. Pursuant to 21 U.S.C. § 350b(a), submission of an NDI notification to FDA is generally required for a new dietary ingredient unless it can be established that
The new dietary ingredient has been present in the food supply as an article used for food and
The ingredient is not “chemically altered” from the form that has been in the food supply. In other words, if the new dietary ingredient is the same ingredient as, or is merely a physically altered form of, a food ingredient that has been in the food supply, an NDI notification would not be required.
· Federal law requires every dietary supplement to be labelled accordingly, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
· The following five elements are mandatory in the labelling of dietary supplements:
The net quantity
The name and place of business of the manufacturer, packer, or distributor.
. The nutrition information shall first list those dietary ingredients that are present in the product in a significant amount and for which a recommendation for daily consumption has been established.
. Other dietary ingredients having no such recommendation must also be listed.
· Any truthful and not misleading claims can be made for products marketed in the US, unless specifically prohibited or regulated.
· FDA also regulates certain claims made for conventional food and dietary supplement labels, including health claims, nutrient content claims and structure/function claims.Declarations on properties related to the function of nutrients, for instance “Vitamin B 12 is necessary for the production of erythrocytes”.
. Health claims describe the relationship between a food or food component and reduced risk of disease or health-related condition (21 CFR 101.14), e.g. “Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.” Health claims are limited to authorized health claims and qualified health claims.
. Authorized health claims require pre-approval by the Food and Drug Administration (FDA) based on significant scientific agreement among qualified experts that the claim is supported by the totality of publicly available scientific evidence or an authoritative statement from a scientific body of the U.S. Government or the National Academy of Sciences.
. FDA has also recognized certain qualified health claims submitted by petitioners that do not meet the significant scientific agreement standard where it has determined there is credible evidence to support the claim. No health claims have been approved for probiotics or prebiotics thus far. Health claims must exactly match the conditions and wording enumerated by FDA.
Nutrient content claims
. Nutrient content claims describe directly or by implication the level of a nutrient or dietary substance in a food or dietary supplement (21 CFR 101.13). Nutrient content claims are limited to those authorized by FDA. Because probiotics and prebiotics are not recognized by FDA as having established Daily Values, claims such as “good source” or “more” could not be made for these. However, certain other nutrient content claims for probiotics and prebiotics could be made, including, for instance, an accurate quantitative statement that does not otherwise characterize the nutrient level in the product (e.g., “2 g per serving”).
. Structure/function claims describe the role of a nutrient or functional component in affecting or maintaining normal body structure or function or general well-being (21 CFR 101.93(f)), e.g. “helps maintain normal cholesterol levels already in the normal range”.
. They may not state or imply that a nutrient or functional component affects a disease or health-related condition associated with a disease via diagnoses, cure, mitigation, treatment, or prevention. Such a claim would be considered a drug claim which would render the product “misbranded.”