What are Dietary Supplements & Dietary Ingredients?
Dietary supplements may be tablets, capsules, softgels, gelcaps, liquids, powders or bars containing dietary ingredients such as vitamins, minerals, herbs, other botanicals, amino acids; dietary substances to increase human total dietary intake like enzymes, organ tissues, glandulars; metabolites, concentrates, constituents or extracts of the above. They exclude tobacco, drugs and moieties for clinical trial investigations except where the article for investigation was used as a dietary supplement or food prior to investigation. As products for ingestion, dietary supplements are regulated as a special category of foods under the Dietary Supplement Health and Education Act (DSHEA) of 1994.
Regulatory Compliance - Industry Obligations & FDA Oversight
Manufacturers and distributors are typically exempt from premarket notification to the US Food and Drug Administration (FDA) for safety evaluations of their dietary supplements. FDA expects manufacturers to ensure they pre-register their facilities, domestic and foreign, pursuant to the Bioterrorism Act and that their dietary supplements are safe for consumption with no labeling bearing false or misleading claims. Manufacturers, packagers, labelers and holders of dietary supplements are subject to Dietary Supplement Current Good Manufacturing Practices (DS CGMP) to ensure their identity, purity, quality, strength and composition. Manufacturers are also responsible for any adverse event investigation and reporting to FDA.
FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is responsible for regulatory oversight of dietary supplements in the US and does so through inspections of manufacturers and distributors, the Internet, consumer and trade complaints, occasional laboratory analyses of select products, and adverse event reports to the agency.
In addition to various, specific labeling compliance requirements such as a supplement facts panel, label claims can require regulatory filings to FDA (Table 1). There are different kinds of label claims. Health Claims are generally risk reduction claims comprising of a substance (whether a food, food component, or dietary ingredient) and a disease or health-related condition. Structure Function Claims address a role of a specific substance in maintaining normal healthy structures or functions of the body. Nutrient Content Claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite. No label claim can be intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.
Table 1: Dietary Supplement Label Claim Submissions
|Dietary Supplement Label Claim Regulatory Submission||
Health Claim Petition
e.g. adequate calcium throughout life may reduce the risk of osteoporosis
The 1990 Nutrition Labeling and Education Act (NLEA) provides for FDA to issue regulations authorizing health claims for foods and dietary supplements after reviewing and evaluating scientific evidence, either in response to a health claim petition or on its own initiative.
Qualified Health Claim Petition
FDA reviews petitions for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. If FDA finds that the evidence supporting the proposed claim is credible and the claim can be qualified to prevent it from misleading consumers, the agency issues a letter of enforcement discretion specifying the qualifying language that should accompany the claim and describing the circumstances under which it intends to exercise enforcement discretion for use of the claim in food labeling.
Structure Function Claim Notification
e.g. calcium builds strong bones, fiber maintains bowel regularity, antioxidants maintain cell integrity
The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for using structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease. General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient. Nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread the disease is in the United States. Structure/function claims for dietary supplements may focus on non-nutritive as well as nutritive effects.
Nutrient Content Claim Notification
The 1997 Food and Drug Administration Modernization Act (FDAMA) provides for health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research; such claims may be used 120 days after a health claim notification has been submitted to FDA, unless the agency has informed the notifier that the notification does not include all the required information.
FDAMA does not include dietary supplements in the provisions for health claims based on authoritative statements. Consequently, this method of oversight for health claims (health claim notifications) cannot be used for dietary supplements at this time. The FDA intends to propose that health claims based on authoritative statements be permitted for dietary supplements.
New Dietary Ingredient Notifications (NDIN)
Dietary ingredients are considered new if they were not marketed in the US before October 15, 1994. Manufacturers and distributors that plan to market a new dietary ingredient (NDI) or a dietary supplement containing a new dietary ingredient that is in a chemically altered form (Appendix 1) from its natural form in food need to file a new dietary ingredient notification (NDIN) with the Division of Dietary Supplement Programs, Office of Nutrition, Labeling, and Dietary Supplements at FDA’s Center for Food Safety and Applied Nutrition (CFSAN) at least 75 days prior to commercialization. Except for trade secrets or confidential commercial information, the NDIN is publicized by FDA 90 days post filing. Copyright content in the NDIN can also be requested under the Freedom of Information Act (FOIA).
FDA Consultant Services - Dietary Supplements / Dietary Ingredients
Our suite of services encompasses all your regulatory compliance needs in relation to dietary supplements and dietary ingredients.
- Current Good Manufacturing Practice (CGMP) compliance for Manufacturing, Packaging, Labeling, Quality Control Testing, Holding & Distribution Operations
- Assessment as to qualification of a dietary ingredient as ‘New Dietary Ingredient’ subject to premarket NDIN filing for Manufacturers & Distributors
- Filing New Dietary Ingredient Notifications (NDIN) for Manufacturers & Distributors
- Electronic Adverse Event (AE) Reporting
- Labeling Compliance (Supplement Facts Panel, Other Ingredient Labeling, etc.)
- Health Claim Petitions
- Qualified Health Claim Petitions
- Structure Function Claim Notifications
- Nutrient Content Claim Notifications
Appendix 1 - Is my NDI Chemically Altered?
Minor loss of volatile components, dehydration, lyophilization, milling, and formation of a tincture or a solution in water, a slurry, a powder, or a solid in suspension do not chemically alter
an ingredient. Examples include:
- Leaves or roots of a plant consumed as conventional food (e.g., broccoli or carrots) are dried and ground for sale in powder form.
- A tincture is made by soaking pears in aqueous ethanol. The mixture is then milled and dried into a powder that is placed in a capsule.
Processes that would likely be considered as involving chemical alteration include:
- A process which makes or breaks chemical bonds such as hydrolysis or esterification, unless the bonds created by the process are reversed when the ingredient is dissolved in water (e.g., creation of a soluble salt) or during ingestion.
- Removal of some components of a tincture or solution in water (e.g., by chromatography, distillation or membrane
filtration), which changes the chemical composition of the mixture.
- Use of solvents other than water or aqueous ethanol (tincture) to make an extract. Water and aqueous ethanol are specifically excluded from processes that chemically alter a food in the official legislative history of DSHEA. Other solvents alter the composition of the extract in significantly different ways, usually by extracting different types of constituents than are extracted using water and aqueous ethanol.
- High temperature baking or cooking of an ingredient that has not previously been baked or cooked, unless the process causes only minor loss of volatile components with no other changes to the chemical composition of the ingredient.
- Changing the manufacturing method for an ingredient such that the chemical composition is significantly different (e.g., changes that alter the composition of materials used to make the ingredient, use of a different solvent, use of a chromatographic matrix instead of a passive filter).
- Application of nanotechnology that results in new or altered chemical properties of the ingredient.
- Changing agricultural or fermentation conditions to alter the chemical composition of the ingredient, such as by sprouting garlic or fermenting yeast using a medium containing large amounts of sodium selenite to create large amounts of organic selenium compounds.
- Fermentation using a fermentation medium different from the one used to make conventional foods in the food supply (e.g., use of a defined commercial growth medium to produce a microorganism previously made by fermenting milk into dairy products like yogurt or cheese).
- Use of a botanical ingredient that is at a different life stage than previously used (e.g., making an extract from unripe
instead of ripe apples or using the mycelium instead of the fruiting body of a fungus).