“Supplementing” Conversation About Nutraceuticals/Cosmeceuticals

March 8th, 2011
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“Relieves, helps, aids, protects, reduces, may help to slow…”
 
Fill in the blank for many products (particularly those labeled nutraceuticals or cosmeceuticals) whose marketers some times “claim” that they can do all or some of the above.
 
These claims can be dangerous, as shown by a recent report in FDA’s Medwatch. The report provided public notification of an “undeclared drug ingredient” in Fruta Planta, a dietary supplement imported from outside the United States.  The FDA had received multiple reports of adverse events associated with the use of the product, which included cardiac events and, in one case, death.
 

There is an increase in consumer focus on health and wellness due to the growth of the population over the age of 65, the rising costs of healthcare, and an interest in preventive natural treatments that extend beyond traditional medicine.  Also, alternative treatments are easily accessible without a prescription at local stores (grocery or pharmacy), from alternative health providers, or via the Internet.   The demand for such products is growing, but with that demand comes added pressure for U.S. governmental regulation.
 
Within this product area, there are claims of improved health, wellbeing, reduced risk of disease, increased energy and vitality, and prevention of the inevitable aging process.   All of which are huge temptations for consumers.
 
There is also increasing federal surveillance of products that make claims indicating they could potentially be drugs, in which case they would fall under FDA’s new drug application purview. Claims for skincare products such as “rejuvenates, repairs or restructures” or “molecules absorb and expand, exerting upward pressure to ‘lift’ wrinkles upward” could be considered drug claims, as well.
 
To define these terms:

  • Nutraceutical (The combination of the words “nutrition” and “pharmaceutical”):a food or a food product used to prevent or treat a condition.
  • Cosmeceutical (The combination of the words “cosmetics” and “pharmaceutical”): an organically active product that alleges to be medically beneficial. Cosmeceutical only refers to products that are applied topically (balms, creams, ointments) and not ingested. Cosmeceuticals may also have nutraceuticals as part of the ingredient list.

 
Under the broad categories of nutraceuticals and cosmeceuticals are an array of terms such as nutrigenetics, nutrigenomics, nutricosmetics, functional food, nutrification, dietary supplements, and functional beauty.
 
Some of the ingredients in these products come from sources such as herbs, teas, fruits, and essential oils and are increasingly labeled “organic,” “all natural” or “ethical.”
 
Chemicals used in cosmeceuticals and nutraceuticals may be extracted from food products such as antioxidants (as found in red wine), probiotics (as found in yogurt), prebiotics (as found in onions and garlic), and Omega-3 fatty acids (as found in fish or algae sources).
 
Typically, nutraceuticals are not regulated in the same way as a pharmaceutical but there are industry standards put forth by organizations such as the American Nutraceutical Association, which works with the FDA to help assure a product is safe.  Cosmetics fall under the FDCA (Food and Drug Cosmetic Act), but cosmeceuticals are not covered by the FDCA.  Clinical evidence of nutraceutical products differs widely—some have been tested with scientific rigor similar to pharmaceuticals and can demonstrate benefit and others have minimal evidence to substantiate their claims.
 
There is increasing concern over the claims and mislabeling made by companies whichmislead and potentially harm the consumer.   Sometimes foreign and domestic products do not indicate how much or what ingredient(s) are actually in the product.  Not until there are reports of unexpected side effects from taking the product does it come to the attention of the public.
 
Manufacturers of nutraceuticals and cosmeceuticals may benefit from accurate disclosure of ingredients, inspections of manufacturing plants, and development of better guidelines on product claims. These requirements would help to prevent contaminated products from reaching the consumer and better inform the consumer about product ingredients.  The addition of new technologies in bioanalytic testing to detect tainted products or significantly elevated amounts of a potentially dangerous ingredient will be critical to these growing markets.
 
So what happens now that nutraceuticals and cosmeceuticals are becoming more commonplace? Will regulation guidelines become more distinct? The first step might be standardizing definitions of these two new words because each one is viewed by the FDA as more like a dietary supplement than a pharmaceutical.
 
What do you think about this topic? Do you take nutraceuticals or use cosmeceuticals? Do you believe their claims? Should the FDA regulate these classes of products? Please share your thoughts here.


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About the Author:

I have 20 years experience in clinical research, including leading diagnostic and pharmaceutical clinical studies in disease areas ranging from cancer to infectious disease to cardiology, diabetes, and autoimmune disorders. Send me an email.

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