USA

I. DIETARY SUPPLEMENTS         

Dietary supplements are defined as “products taken by mouth that contain a “dietary ingredient”. They are mainly regulated by the Dietary Supplement Health and Education Act 1994 (“DSHEA”).

Pursuant to 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.

II. GENERAL STATUTORY AND REGULATORY REQUIREMENTS

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.

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. 

III. COMPOSITION

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 preceding substances.
• 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.

IV. NEW DIETARY INGREDIENTS

A "new dietary ingredient" is defined as a "dietary ingredient that was not sold in the United States prior to October 15, 1994 and does not include any dietary ingredient that was previously marketed in the United States." The FDA has construed the definition narrowly to apply to ingredients that were not promoted as a dietary ingredient in the United States prior to October 15, 1994. Meaning that if an ingredient was present in a food marketed in the United States prior to October 15, 1994, but was used for a different purpose like possessing or coloring, the FDA would not consider proof of that usage adequate to indicate that the component is not a new dietary ingredient.

Although these are not FDA-defined terminology, it is common to refer to dietary ingredients that were marketed in the United States prior to October 15, 1994, as "old dietary ingredients” (ODI) or "grandfathered ingredients". Although there is no official FDA-recognized list of old dietary ingredients, some trade associations have published unofficial lists.

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.

V. GENERAL LABELLING RULES

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 name
• The net quantity
• Nutrition labelling
• Ingredient list
• 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.

VI. HEALTH CLAIMS

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.

VII. 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”).

VIII. STRUCTURE/FUNCTION CLAIMS

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.”