Dietary Supplements: General Information, Regulations, Quality Differences & Resource

1. What is a dietary supplement? 

Dietary supplements are products containing vitamins, minerals, herbs, amino acids, and/or other nutrients that are intended to promote health and support a well-balanced diet and healthy lifestyle. Various forms of these products include capsules, tablets, powders, and liquids. Dietary supplements are regulated as food by the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) as well as by government agencies in each of the 50 states. There are extensive regulations governing dietary supplements in terms of manufacturing, labeling, and marketing.   

2. What is the FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?

Under the Dietary Supplement Health and Education Act (DSHEA), manufacturers are responsible for ensuring that products are safe before they are marketed. Supplements marketed in the U.S. before passage of DSHEA in 1994 are “grandfathered” and assumed to have a history of safe use. If a supplement manufacturer wants to introduce a new ingredient, it must provide FDA with 75 days notice, along with safety information. If the FDA has any concerns about the ingredient or submitted safety profile, the agency can request more information or deny the product’s entry into the marketplace. DSHEA allows the FDA to have additional enforcement authority, including the ability to remove from the market products the FDA deems unsafe through: 1) an “imminent hazard” clause which permits the FDA to remove a product it considers to present an immediate safety concern, and 2) a “significant or unreasonable risk” clause that allows removal of a product considered to pose an unacceptable risk of illness or injury. 

To help ensure the identity, purity, quality, strength, composition, and safety of dietary supplements, the FDA published comprehensive regulations called Good Manufacturing Practices (GMP). These guidelines must be followed by all who manufacture or package dietary supplement products. Regulations have been established for the buildings and facilities, equipment, personnel, raw materials, production, laboratory controls, records, labeling, and complaints.  

3. Examples of GMP guidelines include:

• Raw materials are tested and examined to assure the absence of contamination with filth, microorganisms or other extraneous substances to prevent adulteration of finished products.
• Every finished batch of dietary supplement must meet each product specification for identity, purity, strength, composition and for limits on contamination.
• Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
• Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
• A system is available for recalling any batch from sale or supply, if necessary.

4. Are supplements and drugs regulated in the same way?

No. If supplements were regulated like drugs, dietary supplements would no longer be affordable to consumers. And, while drugs are subject to pre-market approval it is not a guarantee of safety, as seen by the many drugs that have been approved by the FDA, only to later be recalled due to safety concerns. Like food products, dietary supplements do not undergo pre-market approval, but that does not mean that companies do not do testing, or that products are unsafe. There are provisions under DSHEA that protect consumers from potentially unsafe products. DSHEA provides FDA with appropriate regulatory authority while still allowing consumers to have the desired access to a wide variety of affordable, high quality, safe and beneficial dietary supplement products. The overwhelming majority of dietary supplements are safely used by 150 million Americans annually.

5. Adverse event reporting

Manufacturers and distributors of dietary supplements must record, investigate and forward reports to the FDA if they receive notice of any serious adverse events associated with the use of their products. The FDA will evaluate these reports and any other adverse event information reported directly by healthcare providers or consumers to identify early signals that a product may present safety risks to consumers.
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products.

6. Supplement Adverse Event Reports vs. Pharmaceutical Adverse Events Reports (fda.gov)

• Supplements: 1,275 reactions in 2009
• Pharmaceuticals: 580,904 reactions in 2009

7. Differences in Supplement Quality

Beyond GMP measures that ensure supplement safety, other factors can help to distinguish supplement quality. For example, certain supplement companies in the industry go to great lengths to promote product efficacy. This means that they formulate their products using the latest clinical research and include optimal nutrient forms and therapeutic dosage levels in their supplements. They also make it a priority to produce products that are hypoallergenic by excluding binders, fillers, dyes, coatings, and common allergens such as soy, gluten, dairy, and corn. Because there are so many products available and we are all unique, it is always best to seek the advice of an expert when choosing dietary supplements. Health professionals can provide specific product recommendations to help ensure that the supplements are best suited to meet your individual needs.

Helpful Resources
Council for Responsible Nutrition - www.crnusa.org
Natural Products Association - www.npainfo.org
U.S. Food and Drug Administration – www.fda.gov
Federal Trade Commission – www.ftc.gov

Village Green Apothecary has been providing individualized nutrition, pharmacy, and healthy living products for 45 years. We are committed to providing you with expert guidance, knowledge, and a custom-tailored mix of nutritional and pharmaceutical products needed to achieve and maintain optimal health. Our staff of 45 professionals (including a team of pharmacists, nutritionists, naturopathic doctors, and clinical herbalist) offer private wellness consultations, personalized health plans using The Essentials of Healthy Living (EHL), and individualized custom compounding. Our pharmacists are available to review and address drug/nutrient interactions and depletions to ensure your health and well-being. Please contact us with any questions. We are here as a resource for you.

Village Green Apothecary
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