I guess adding “ceuticals” to a word helps to market a product. I just posted one on cosmeticeuticals and now I’m reading about bioceuticals and not to mention ”bio” being the latest edition of buzz words. I guess we have a love/hate relationship with the pharmaceutical world as on one hand, we embrace anything with “pharmaceutical” in it but balk and cry foul over high prices or whenver a horrible adverse event occurs in spite of the pre-existing warnings identified and mandated on every script sold.
What is a bioceutical? According to Astro Bioceuticals, “remedies derived from natural plants and their derivatives have been used traditionally in various cultures around the world and are still used today to successfully treat many common health concerns. This type of remedy has been termed bioceutical. Such products may range from isolated nutrients, dietary supplements and specific diets to genetically engineered designer foods, herbal products, and processed foods such as cereals, soups and beverages.”
The FDA does not regulate this type of business but they are allowed to market their products to appear as if they are a pharmaceutical product. Take Biotivia products, for instance, their website on Resteratrol supplements has a host of products with “bio” in the name. These products range from the infamous Resteratrol to weight loss to immune support. You can get discounts on bulk purchases and on automatic shipment programs with the option to cancel at anytime.
Their website boasts a lot of information on how they came Biotivia and the process behind their “unique” products: http://www.biotivia.com/company.html
A story in 2008, noted a competitor of Biotivia complained about their claims “but most of Biotivia’s print, online and labeling claims were deemed to be “sufficiently supported” by the National Advertising Division of the Council of Better Business Bureaus (NAD).”
The story provided further information of:
“In response to the challenge, Biotivia voluntarily removed disease-related claims which NAD noted was “both appropriate and necessary”. NAD told the firm it must discontinue claims that its products are processed in a plant that has been GMP-certified by the FDA. NAD noted there was a reasonable basis for the claim of a 24-month active life but told the company not to suggest this was unique to its product. The claim that Transmax was being used by universities outside the US was also deemed to be usable, as long as Biotivia disclosed the location of the universities. It also said Biotivia should more clearly disclose on the label the fact that the resveratrol source is the knotwood plant and not grapes which images of grapes on the label suggest. Biotivia said it was “more than willing to implement the suggested clarifications noted” in NAD’s final decision.” NAD ruled in Biotivia’s favor over the rest of the claims.”
Keep in mind that NAD is a New York based voluntary media watchdog group where businesses can pay a fee to provide “scrutiny” on the truth and accuracy of the claims being made. There is no recourse if a company does not comply with the NADs findings. However, the NAD does have the authority to refer issues to the FDA and FTC. The competitor of Biotivia paid $6,000 to have their claims assessed.
The Dietary Supplement Health and Education Act of 1994 does state that the FDA can go after a product when issues are arising. Although manufacturers are required to inform that FDA on adverse events it’s completely up to the consumer if they report the event to anyone. I know I never have as I never knew there was a forum to be heard. Contact 1-800-FDA-1088 or visit http://www.fda.gov/medwatch/how.htm.
According to one doctor in 2008, no clinical trials have been conducted in humans on Resveratrol so the claim of improvement is hardly there (http://scienceline.org/2008/01/23/health-stern-aging/). The problem with the entire business is, for every doctor that says one thing, you can find another stating otherwise. It’s why it’s called practicing medicine and I’m all for trying out natural alternatives as long as there is some safety regulations in place.
June 23, 2009 at 5:21 pm
Agreed. Vinomis Laboratories has a new product Vindure 900, with over 900 mg of Resveratrol, Quercetin, and red wine grape extracts. http://www.vinomis.com
The product is “nutraceutical” grade. U.S. supplements cannot claim to be pharmaceuticals, however, Vinomis’ manufacturing, for example has been certified by the FDA, and agency certification outside the US such as Australia (TSA). These other countries use terms like pharmaceutical grade, etc.
While nutraceuticals are not strickly monitored by the FDA, there is a significant difference between products. Look for things like:
- Purity. Resveratrol, for example should be 98%+ pure. This is the good stuff. If the purity is not listed on the bottle, you don’t know what you’re getting
- Approvals for the manufacturing plant – i.e. FDA, TSA, etc. These plants are regulated for their quality and do extensive testing.
June 23, 2009 at 7:38 pm
Thanks for the articles, I enjoy reading them.
I will be sure to pass your site onto my family, friends and patients.
All the best
Dr. Brian
June 23, 2009 at 7:46 pm
Thanks, Dr. Brian! I looked at your site and will take a more thorough review once I get a free moment. I’m very much interested in reading about your allergy treatment. I have a child with severe allergy and/or asthma issues and would like to research more into the natural alternatives. Judy
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June 23, 2009 at 9:35 pm
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August 2, 2009 at 7:33 pm
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