label packaging

Since the 80’s we have grown more accustomed to use dietary supplements as part of our daily lives, not only as ways to increase the amount of certain missing substances, like vitamins or minerals.

We use supplements to lose weight, to gain mass, to increase our resistance to effort or to calm down after a stressful day. Yet, supplements, are not really food, neither drugs, therefore stating clear rules regarding use, packaging and labeling is hard, and sometimes is seems that this market is not properly regulated.  A specialized blog states about the FDA rules regarding supplements:

“How dietary supplements are regulated represents something of a logical compromise between new drugs and new foods. New drugs require FDA approval of their indication and labeling and manufacturing process before marketing. New foods do not. Dietary supplements don’t require approval before marketing, but their makers are required to assure the ingredients are safe and manufactured and labeled correctly, and have to have substantiation for any claims they make.”

This situation leads to unwanted problems sometimes, after a supplement is released and afterwards found unsuitable for its purpose or even dangerous for use.

The European supplements market is a bit different, since the European Food Safety Authority (EFSA) classifies supplements as food, and regulates them accordingly, with a special focus on the amounts of vitamins and minerals included in each dose.

“In the EU, food supplements are regulated as foods and the legislation focuses on vitamins and minerals used as ingredients of food supplements. The Directive 2002/46/EC sets out labeling requirements and requires that EU-wide maximum and minimum levels are set for each vitamin and mineral added to supplements. As excessive intake of vitamins and minerals may result in adverse effects, the Directive provides for the setting of maximum amounts of vitamins and minerals added to food supplements.”

Coming back to the situation in the US, one can imply that the rules are less strict, since the label only requires a Supplement facts panel with the following information:

 

  • Serving size information
  • Names and quantities of each ingredient
  • Total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron
  • Dietary ingredients with no daily value must be listed by common name
  • Amount per serving (this can be worded as: amount per capsule, packet, per 2 tablets, etc.)
  • Percent daily value must be declared on all dietary ingredients

 

For dietary supplements, this label is not required to present information regarding vitamins and minerals. A declaration is only required when the vitamin/mineral is added to the product for the purpose of supplementation or if a claim is made about them.

If you are a supplements manufacturer it is a good idea to have professional equipment to help you pack and label each box according to the rules of the target market countries.

You could use blisters, Tyvek pouches, poly bags, wax cardboard boxes or even plastic packaging, depending on the type of supplements you are producing: pills, powders, protein bars or sports drinks.

After you design your label following the requirements dictated either by FDA or EFSA, you can use Doranix’s products, to help you print the information on any given material such as poly, tyvek, paper or cardboard. If you need a product compatible with sterilization we recommend the Thermaprint 64 (wide) and if this is not an issue, but you are rather looking at large volumes needed to be printed (up to 5000 copies per hour) a machine such as the LPA 5000 could be the perfect choice for your business. The advantage, compared to pre-printed labels comes from the fact that these machines allow you to use your own serial numbers and keep track of product batches.