Vitamins and herbal supplements are more popular than ever and usage rates have skyrocketed in the past decade. The myriad of health claims supplements tout can leave consumers feeling perplexed. The Food and Drug Administration (FDA) does not regulate supplement manufacturing as supplement companies do not need to register with the FDA nor get FDA approval on a product. Although that seems like a glaring downside, it does have its pros and cons. The con is that there are no regulating standards or guarantee of quality or potency of supplements; such that some can claim an adequate dose of a vitamin or herb and not contain any at all. The pro of minimal FDA regulation is that you have more options as a consumer and prices remain relatively inexpensive- and it really forces us as consumers do our homework about what it is we are buying. In addition, the FDA can still take action against any supplement found to be unsafe. It is also important to note that manufacturers cannot put a patent on a supplement or vitamin which unfortunately has limited the number of long term research studies. What can be patented, however, is what is called a “proprietary blend” – a term usually seen on herbal supplements. Typically, a proprietary blend is a combination of herbs and vitamins that function together. You might see a “detox” or “liver cleanse” supplement with a proprietary combination of herbs.
Speaking of labels, it is important to be an avid, savvy food label reader and supplements are no exceptions. It began in 1990 with the Nutrition Labeling Act whose purpose was to set the guidelines for supplement labeling. Also, in 1990, the United States Pharmacopoeia (USP) published the fist standards for multi-ingredient vitamin and mineral products. Next to follow was the FDA’s ANPR- Advanced Notice of Proposed Rule Making. The ANPR suggested that vitamins and minerals be limited to low multiples of the Reference Daily Intakes (RDI’s) noting that some botanicals were inherently drugs, not supplements, and amino acids were food additives. This was rather ground breaking because supplements are not considered drugs as legal status and forced both manufacturers as well as the FDA to define herbal supplements.
Brought about by consumer concern was the Dietary Supplement Health and Education Act (DSHEA) in 1994. This set the standards used today. The DSHEA brought about the following regulations:
- Define Dietary supplements as food not additives or drugs
- Put the burden of proof on the FDA (that the product label is truthful and not misleading)
- Third-party literature may be used in connection with sales of supplements
- Labeling requirements
- Allows structure/function claims on labels
- Required manufacturer’s to use GMPs (Good Manufacturing Practices) for potency, cleanliness, and stability
- Created the Office of Dietary Supplements and Commission on Dietary Supplement Labels
In regards to “structure/function” claims, the DSHEA allows free reign to make these claims as long as the companies:
- Notify the FDA within 30 days after using a new claim
- Print the following disclaimer on the label: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease”
Structure function claims are claims seen on labels for foods or supplements that suggest a health benefit of the food or herb. For example, “improves memory”, “prevents wrinkles” or “helps you relax” are all claims that require no prior approval by the FDA.
In 1999, The Consumer Lab was founded (CL) and today is the leading provider of independent test results and information aiding consumers in evaluating quality supplements. CL also serves as a watchdog over the supplement industry. Another great resource for quality assurance is the U.S. Pharmacopeia (USP), a not-for-profit official standard setting authority for pharmaceutical and over the counter drugs as well as supplements. USP sets the standards for strength, quality, purity, and consistency and is used in over 130 countries around the world.
Currently, supplement labels must include:
- Manufacturer’s information: place of business, phone number, and address
- Serving size, amount per serving, and %DV
- Name of product
- List of Ingredients
- Proprietary blend: total weight, compounds in descending order
- Directions for use
- Other ingredients (fillers, stabilizers, etc)
Also monitoring supplement claims is the National Sanitation Foundation (NSF), a not-for-profit international agency that aims to protect public health and the environment by developing national standards for food and supplements while providing scientific research. The NSF label seen on supplements means it has met the 4 main components of the NSF Dietary Supplement Certification Program:
1) Verification that the contents of the supplement actually match what is printed on the label
2) Assurance that there are no ingredients present in the supplement that are not disclosed on the label
3) Assurance that there are no unacceptable levels of contaminants present in the supplement
4) Compliance with GMP (Good Manufacturing Practice)
Stay tuned for supplement savvy shopping tips!