In keeping with your efforts to build brand equity with consumers, creating label packaging that is straightforward, honest, and in accordance with FDA guidelines is always a best practice. Be sure to provide all the required information and disclaimers on each of your products. Errors or omissions can be costly and devastating to your business if they run afoul of federal regulations.
Dietary Supplements Defined
A dietary supplement is a product (other than tobacco) that
is intended to supplement the diet;
contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;
is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and
is labeled on the front panel as being a dietary supplement.
Are Supplements Regulated?
Many consumers, and seemingly some manufacturers, are under the impression that dietary supplements are largly unregulated. Though many regulations are less than 10 years old, they do exist and they are enforced by the Food and Drug Administration.
Good Manufacturing Practices
Since 2007 dietary supplements have been required to follow Good Manufacturing Practices (GMPs) which govern their preparation, manufacturing, and storage to ensure quality. Supplement manufacturers are expected to guarantee the identity, purity, strength, and composition of their products. GMPs are intended to prevent the inclusion of wrong ingredients (including using too much or too little of a vitamin or supplement ingredient), eliminate the possibility of contamination by pesticeds, heavy metals such as lead, bacteria and more. The GMPs are also intended to prevent improper packaging and supplement labeling, and all labels must contain contact information which will allow reporting of "adverse events". Supplement manufacturers are required to register their facilities with the FDA.
The types of claims allowed on dietary supplements and drug packages are starkly different. In 1994 the FDA established the Dietary Supplement Health and Education Act, which defines special regulatory procedures for claims made on dietary supplements.
Put simply, vitamin and supplement labels are required by law to be truthful and not misleading, and if the FDA determines this requirement has not been met they are authorized to remove the product from the marketplace or take other action. Manufacturers of dietary supplements that make health, nutrient, or "structure/function" claims on labels or packaging must submit a notification to the FDA no later than 30 days after marketing the dietary supplement that includes the text of the claim. Manufacturers of pharmaceutical drugs are allowed to claim their drugs can diagnose, cure, mitigate, treat, or prevent a disease. Vitamins and supplement products cannot claim to treat or cure any disease or disorder. They are only allowed to make these three types of claims:
A health claim, such as "antioxidants maintain cell integrity". Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition.
A nutrient content claim, such as "200 mg of sodium". Nutrient content claims describe the level of a nutrient or dietary substance 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.
A structure/function claim, such as "calcium builds strong bones". Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans. Structure or functions claims for dietary supplements may focus on nutritive as well as non-nutritive effects.
As part of these regulations, all label packaging claims must be accompanied by the following disclaimer:
“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.”
If your labels make a "disease claim" (by claiming to treat any disease, for example "for the treatment of depression"), the FDA will consider the product an unapproved drug. In other words, if you include claims about treating diseases your products are legally bound by the same strict regulations as pharmaceutical drugs. As an unapproved drug, the FDA may take enforcement actions against your company. Enforcement actions can range from warning letters, seizure of your products, seeking an injunction to ban the sale of your supplements, and criminal prosecution.
Either through ignorance of the law or oversight, mislabeling of vitamins, supplements, and nutraceuticals persists to this day. The Office of Inspector General recently released a report indicating up to 20-30% of supplement manufacturers were falling short of FDA regulations. The most common types of violations were:
Prohibited claims. 20% of labels reviewed made health, nutrient, or structure/function claims prohibited by the FDA.
Missing contact information. 20% lacked the required information for adverse event reporting.
Failing to register facilities. 28% of labels originated form facilities that had not registered with the FDA as required.
If space is an issue as you consider how best to include all the required wording, Advanced Labels NW offers several options for labels that require information that is difficult or impossible to include in a small space. Extended content booklet labels and extend a labels have multiple panels and offer all the spcae you could need to stay in compliance while still communicating your brand message.
Ultimately, following the GMPs and FDA labeling requirements should be a priority for your vitamin supplement business. Building brand equity through honest and straightforward labeling requires some effort, and we hope this quick reference will help you navigate through the process.
For more information about structure/function claims on dietary supplement labels, visit the FDA website.
Office of Inspector General. Department of Health and Human Services. Report No.: OEI-01-11-00211.