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Making Sure Nutraceutical Labels are in Tip Top Shape

This blog is for informational purposes only and all dietary supplement labels should follow current FDA regulations.  Label Tech Inc. is not an authority on FDA regulations.  For FDA regulations click here.

The nutraceutical industry is rapidly expanding, encompasses everything from vitamins and herbal products to genetically modified foods and processed foods.  Dr. Stephen DeFelice coined the name “nutraceuticals” and he defined it as “Food, or parts of food, that provide medical or health benefits, including the prevention and treatment of disease”.  Nutraceuticals can be classified as either dietary supplements or functional foods. 

This blog will look at dietary supplements and their labeling requirements.

A dietary supplement is a product (other than tobacco) that contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals; amino acids; and other substances) or their constituents.  Dietary supplements are to be taken by mouth in pill, capsule, tablet or liquid form and is labeled on the front panel as being a dietary supplement.

Not everyone in the dietary supplement business is aware that the Food and Drug Administration (FDA) requires compliance with the Dietary Supplement Health and Education Act (DSHEA) in manufacturing, packaging, labeling, and holding operations for dietary supplements.  Any company involved has to establish and to follow DSHEAs to ensure that packaging and labeling are done as specified in the master manufacturing record and to ensure the quality of the product that reaches the market.  Practitioners such as herbalists, acupuncturists, naturopaths, and other related health care providers are subject to the DSHEA’s rule.  DSHEA is meant to reassure consumers that dietary supplements will not have; unsafely high ingredient concentrations, harmful contamination from substances such as toxins, bacteria, pesticides, glass, lead, or other heavy materials, inaccurate ingredient statements on the Supplement Facts label; or misleading claims about ingredients and health benefits.

Dietary Supplements

First off, the label must contain the name of the product (including the word “supplement” or a statement that the product is a supplement).  It must include net quantity of contents, serving size, amount per serving (by weight), as well as directions for use.  The DSHEA requires that the label contain the dietary ingredients specified in the master manufacturing record.  Dietary supplement labels must include: a Supplement Facts panel for all active ingredients; an “Other Ingredients” panel that lists every inactive ingredient contained in the supplement product; and a statement identifying the product as a dietary supplement; and Supplement labels must also state the name and address of the manufacturer, packer or distributor.  If the product is an herbal, the label must also state the plant from which the supplement is derived. 

So-called “health claims,” which suggest that a product can prevent, treat, or cure disease, are strictly regulated by the FDA.  Under DSHEA, however, manufacturers of supplements can make “statements of nutritional support” without FDA approval, as long as a statement is true and not misleading.  Such statements usually describe the supplement’s effect on the “structure or function” of the human body (known as “structure/function claims”) or the effect on a person’s general “well-being.”

Not surprisingly, manufacturers take great pains in product marketing to use statements that qualify as structure/function claims, not as health claims. This often requires linguistic somersaults. A manufacturer of saw palmetto, for example, cannot claim that its product “prevents prostate cancer,” but can say instead that the product “helps maintain prostate function.”

It’s fine to make “claims of nutritional support” on your supplement label, as long as you have the data to justify your claims.  

However, supplement labels with claims regarding functional health benefits such as “calcium builds strong bones” must include a disclaimer on the label, which states that the FDA has not evaluated the claim and that the product is not intended to “diagnose, treat, cure or prevent any disease.”  Despite this disclaimer, all health claims must be truthful and not misleading to consumers – or the FDA will recall the product and may fine the manufacturer.  It is illegal to make a dietary supplement label claim that indicates that the supplement is a treatment or cure for any condition or disease.

Whether it’s a straight forward label or a complex Expanded Content Label be sure to understand the FDA label requirements before printing your label.

Topics: dietary supplements nutraceutical labels pharmaceutical labels
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