Does the FDA regulate dietary supplements? Many people are surprised to learn that they don’t; at least not the way they do for drugs.
When you search for the Food and Drug Administration (FDA) on Wikipedia this is part of the definition you get:
The Food and Drug Administration (FDA or USFDA) is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements.
In this case “control and supervision” means having guidelines in place for manufacturing procedures, labeling requirements, and health claims; but the FDA does not regulate dietary supplements like they do for drugs. In order to bring a drug into the marketplace, a company must prove the drug safe by going through clinical trials, submitting data and being granted approval from the FDA before being available to the public.
The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs. Because of this, dietary supplements are not subject to the safety and efficacy testing requirements imposed on drugs and do not require prior approval by the FDA before being sold on the market.
Supplement regulations that are in place
The FDA does regulate the claims made in the labeling about both the composition and the health benefits of a supplement.
What is a claim?
Drug manufacturers may claim that their product will diagnose, cure, mitigate, treat, or prevent a disease. Such claims may not legally be made for dietary supplements.
Supplements can make one of 3 types of claims:
Describes a relationship between a dietary supplement ingredient and the reduction in risk of developing a disease or health-related condition.
Nutrient content claim
A statement on a product label that describes the amount of a nutrient or dietary substance in a product. Examples of nutrient claims for dietary supplement products include fortified, high, rich in, excellent source of, good source of, and high potency.
A statement on a food or dietary supplement label that describes how a product may affect the organs or systems of the body; a specific disease cannot be mentioned. For example, a label cannot say treats constipation, but it can say “bowel movement assistant”. Because constipation is a recognized disease, a supplement cannot claim to treat/fix the condition. Likewise a label cannot say “for osteoporosis” but it can say “bone density assistant” because this is not referring to a specific disease.
Labels must also include a disclaimer that reads, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Current Good Manufacturing Practices (cGMP)
As of 2011 all dietary supplement manufacturers assures that products are of high quality and do not pose any risk to the consumer.
cGMP basic principles:
• Manufacturing facilities must maintain a clean and hygienic manufacturing area
• Controlled environmental conditions in order to prevent cross contamination
• Manufacturing processes are clearly defined and controlled
• Manufacturing processes are controlled, and any changes to the process are evaluated
• Instructions and procedures are written in clear and unambiguous language
• Operators are trained to carry out and document procedures
• Records are made during manufacturing that demonstrate that all the steps required by the defined procedures were taken and that the quantity and quality was as expected
• Records of manufacture to be traced and retained
• The distribution of the food or drugs minimizes any risk to their quality
• A system is available for recalling any batch
• Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence
Certificate of Analysis
A document that confirms that a product meets its product specification. They commonly contain the results obtained from testing performed as part of quality control of an individual batch of a product.
The Department of Health and Human Services outlines the key elements of a label as:
Supplement Facts panel:
Product serving size: One serving equals the maximum amount recommended for consumption. For example, if the directions on your label say to take 1-3 tablets, the serving size would be 3 tablets.
Servings per container: If taking the recommended serving size, thisdenotes how many times you can expect to take the product before it is gone.
Percent daily value: The % DV is the percent of the Daily Value of a dietary ingredient that is in a serving of the product. Percent Daily Values are based on a 2,000 calorie diet. The % DV must be declared for all dietary ingredients for which FDA has established Daily Values. Examples of daily values include: Vitamin A, Calcium, Iodine, and Iron. A full list of the reference values is published on the National Institutes of Health website.
You must place a symbol in the column for “% Daily Value” that refers to the footnote “Daily Value Not Established”
• Statement of identity: that contains the words “dietary supplement.” The word “dietary” may be replaced by the name of the dietary ingredient (e.g., “ginseng supplement”)
•Net quantity: of contents (for example, “60 capsules”)
• Disclaimer: if the supplement bears a claim to affect the structure or function of the body (structure/function claim), a claim of general well-being, or a claim of a benefit related to a classical nutrient deficiency disease. This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
• Name and place of business of the manufacturer, packer, or distributor
• List of ingredients by their common or usual names, either in descending order of prominence or with the source of the dietary ingredient in the “Supplement Facts” panel following the name of the dietary ingredient (for example, calcium (from calcium carbonate))
• Claims and statements of quality assurance: at their discretion, manufacturers may add additional information on labels, and may decide on the placement of that information on their labels.
• Other ingredients:
nondietary ingredients such as fillers, artificial colors, sweeteners, flavors, or binders
• Part of the plant used, if an herb or botanical
• Proprietary blends: the net weight of the blend as well as a listing of each ingredient in descending order of weight must be identified
• Safety information: anything considered “material” to the consequences that may result from the use of the supplement
Why values sometimes are not shown for every ingredient: Proprietary Blends
The DSHEA requires companies to list the ingredients in their products, but not the amount if they are considered a trade secret. Many companies do not want to list the amounts of their ingredients for fear of copycats.
Companies must identify proprietary blends by use of the term “Proprietary Blend” or an appropriately descriptive term. On the same line, you must list the total weight of all “other dietary ingredients” contained in the blend. Indented underneath the name of the blend, you must list the “other dietary ingredients” in the blend, either in a column or linear fashion, in descending order of predominance by weight. These ingredients should be followed by a symbol referring to the footnote “Daily Value Not Established.”
When does the FDA regulate dietary supplements?
FDA does not have the authority to approve dietary supplements before they are marketed to consumers. However, they do have the authority to take enforcement after a product is on the market when it can establish that the dietary supplement is adulterated (e.g., unsafe); misbranded (e.g., misrepresentations are made on the product labeling); or cannot be marketed as a dietary supplement (e.g., an unapproved new drug).
The Gluten-Free Remedies’ Approach
When coming up with new products to bring to the market, we research and read many studies to verify a product’s effectiveness. It is our goal to bring to the marketplace, high-quality products you can trust. We believe natural alternatives are a valuable choice for people and can be, at times, just as effective as drugs.