Nutraceuticals - Regulatory Path or Marketing Ploy?

A fairly novel and unique category of products, Nutraceuticals is an umbrella term which includes herbs, vitamins, supplements, proteins, whey powders and other food products and dietary supplements that provide various health benefits. “Nutraceuticals”, a cross between “nutritional” and “pharmaceutical”, are nutritional products that act as medicines but is not a term widely recognized by agencies such as the FDA.

Labeling a product as a Nutraceutical is a great marketing strategy - but is it beneficial as a regulatory path? The answer, unfortunately, is no. These products can be purchased over the counter and do not require a prescription. Although many consumers regularly take these products without any negative side effects, the truth is that they actually are not regulated by the FDA or any other agency so it’s really important that people pay attention to what and how much they are taking, especially when combined with other nutraceuticals and medications.

Within our regulatory framework Nutraceuticals are considered to be food supplements and their labels must follow the current guidelines. Some people initially believe these products to be something in between a food supplement and a drug, but in our experience they are almost always the former. It’s very important to properly classify your product in the correct category so that you’re not attributing properties that it does not have or that are not considered under regulations - which could lead to a lack of compliance with health authorities like the FDA. The following five statements are required on Dietary Supplement labels:

  1. Statement of Identity (name of the dietary supplement)
  2. Net Quantity of Contents statement (amount of the dietary supplement)
  3. Nutrition labeling
  4. Ingredient list
  5. Name and place of business of the manufacturer, packer, or distributor

These statements must be placed either on the front panel of the label (the principal display panel, or PDP) or on the information panel (typically the label immediately to the right of the PDP as seen by the consumer when facing the product), unless otherwise specified. The Statement of Identity and the Net Quantity of Contents statements must be placed on the PDP as well.

Generating the correct claims for these labels often proves to be difficult and, sometimes, controversial. These claims are divided into five sub-groups:

  1. Nutrient Content Claims
  2. Nutrient Content Claims
  3. High Potency Claims
  4. Percentage Claims
  5. Health Claims and Structure / Function Claims

It is important for consulting companies (like us) to identify the claim that a client wants to use and to then use it appropriately – meaning they’re in line with the regulations. Knowing what those regulations are and how to use the claims correctly is crucial for both the client and potential consumers. If you are thinking about marketing your product as a Nutraceutical and would like more information, please contact us today at info@rqmis.com.

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