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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

What the Heck is Four-Color Process? AKA 4CP.

What the heck is four-color process or what is commonly referred to as full color? Well, don’t feel bad about not knowing or having limited knowledge on the subject. In flexographic printing and digital printing it is good to have a brief understanding of what 4CP stands for and what it can do for your labels. CMYK and full color are both commonly referred to terms in label printing. Full color is not anything special so don't worry about your friends laughing at you for not understanding what it means. It is just a commonly referred to term for 4CP. CMYK is important. CMYK refers to the colors that are used in four-color process: cyan, magenta, yellow, and black. The true meaning of the K is for Key Plate, however to make things simple let's just refer to it as the black plate. Click here to find out about our prepress department. Printing in 4CP allows for the printer to construct any color in the Pantone (PMS) book from these four colors. In doing so it allows the graphic designer who is creating your labels to get way more creative in designing your labels.

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Side note: if you want a "spot color" then you are referring to us picking an actual PMS number out of the pantone book. If you look in a "bridge" book then you can see the difference between making a color out of 4CP versus using the actual color itself. It is a subtle difference but good to take in to consideration when designing a label.

The CMYK process works by partially or entirely subtracting reflective light from whatever surface it is covering. In most cases the surface is white and often times when a Flexographic printer is printing on clear surfaces they will first lay down a coat of white to get a better color reflection, much like a painter laying down a base coat. 

Label Tech Inc has become an expert at four-color process printing. We run 4CP on many of our flexographic Mark Andy presses and we also run 4CP on our digital press. 

Printing a four-color process image and then laying down one or more spot colors can make for a label that has pop or more shelf appeal then your competitors. Stay tuned for more info from Label Tech Inc on labels and labeling. 

Topics: four color process 4CP labels label tech inc digital printing salsa label multiple sku printing Color match issues for labels color consistency color inconsistency labels coupon labels Pressure Sensitive Labels beverage labels food labels flexographic label printing cosmetic labels pharmaceutical labels consumer product labels

Label Tech Inc, your expert in Flexographic Label Printing.

Welcome to the Label Tech Inc Blog, we hope to be your new experts in Flexographic, UV Flexo, Rotary Screen or Digital Label printing. Wondering who we are? Take a look!

Label Tech, Inc. was founded in 1985. The company has grown to over seventy employees with eleven presses, including digital technology, housed in a forty thousand square foot workplace.

Label Tech is a recognized industry leader, and our quality program became ISO registered in 1998. In addition, Label Tech is a UL, CSA and FSC Forest Stewardship Council approved printer.

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Over the twenty plus years of servicing our clients, we have developed a highly skilled and dedicated work force producing top quality labels, tags and tickets for thousands of products and applications in the United States as well as internationally.

Whether you need product shipped around the corner or around the world we stand ready to meet your requirements. Call on our experienced professional staff to assist you with your labeling requirements.

Topics: coupon labels beverage labels cosmetic labels pharmaceutical labels consumer product labels UL labels
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