What are nutraceuticals?
Nutraceutical are vitamins herbs and other dietary supplements produced for oral consumption. According to the FDA neutraceuticals are categorized as “dietary supplements”. These are extracts, concentrates or combinations of vitamins, minerals, botanicals, herbs, or dietary substances “for use by man to supplement the diet by increasing the total dietary intake.”
Nutraceuticals are used to treat a variety of symptomatic clinical conditions such as arthritis and joint pain. In addition they are used to improve performance in the gym and competitive sports.
Does the FDA regulate nutraceuticals?
The nutraceutical industry is NOT regulated by the FDA in the way that drugs and IV therapies are. The FDA approves new drugs and biologics and has regulatory oversight over the manufacturing and labeling process. Oral Dietary supplements (nutraceuticals- vitamins and herbs) are not reviewed and approved by FDA and the producers of nutraceuticals are merely required to register their manufacturing facility with the FDA and comply with good manufacturing process, such as employee practices, and sanitation requirements etc.
What is Label Fraud?
Label fraud is a term used to describe the mis-representation on the label of what is actually contained in the nutritional supplement. For instance, the label may say that the capsule in the bottle contains ‘pure seedless black raspberry powder’ and when opened and tested it is found to contain no black raspberry at all, just non-descript fillers.
How Common Is It?
As it turns out Label Fraud is VERY COMMON.
A study published (BMC Med2013 Oct 11;11:222. doi: 10.1186/1741-7015-11-222) DNA barcoding detects contamination and substitution in North American herbal products concluded that Most of the herbal products tested were of poor quality, including considerable product substitution, contamination and use of fillers. Product substitution occurred in 30/44 of the products tested and only 2 out of 12 companies had products without any substitution, contamination or fillers. Some of the contaminants were also found pose serious health risks to consumers.
A literature review of testing on popular sports supplements published (Nutr Hosp 2021 Jul 29;38(4):839-847.doi: 10.20960/nh.03413.Fraud in nutritional supplements for athletes: a narrative review.) showed that nutritional labeling differed substantially from the actual amounts of ingredients present in the product. This was found for protein powder supplements, pre-workout mixtures, creatine, and beverages containing vitamins and minerals, among others.
In 2015 A.G. Schneiderman asked major retailers to halt sales of certain herbal supplements as DNA tests fail to detect plant materials listed on majority of products tested cease and desist letters were sent to GNC, Target, Walgreens and Walmart as most store brand supplements were found to contain contaminants not identified on ingredient labels; just 21% of supplement tests identified DNA from plant species listed on labels
The authorities said they had run tests on popular store brands of herbal supplements at the retailers — Walmart, Walgreens, Target and GNC — which showed that roughly four out of five of the products contained none of the herbs listed on their labels. In many cases, the authorities said, the supplements contained little more than cheap fillers like rice and house plants, or substances that could be hazardous to people with food allergies.
What is the harm of Label Fraud?
These fraudulent activities dilute the effectiveness of otherwise useful remedies, lower the perceived value of all related products, take healthcare dollars from people who could otherwise deploy the financial resources for treatment of value and also put consumers at risk for deleterious health effects through consumption of products that they may be allergic to or otherwise unhealthy.
How do I get the benefits of nutraceuticals without falling prey to Label Fraud?
The best way to get proper nutrients is generally through natural consumption. Eating nutritionally dense food in the proper balance has the potential to deliver adequate levels of essential nutrients. This can be difficult for some people because of a busy work/family schedule, allergies that prevent them from eating certain foods, dietary restrictions and gastrointestinal problems that reduce the proper digestion and absorption of nutrients.
What is IVMT?
IVMT, Intravenous Micronutrient Therapy is an established method for delivering essential vitamins and micronutrients directly into the bloodstream.
Are the products in IVMT FDA regulated?
Yes. The nutrients delivered by intravenous administration from a medical professional are purchased from accredited distributors and pharmacies and are under FDA regulation. They are subject to the same regulations as medications. There is no Label Fraud under these circumstances. The nutrient value listed on the label is representative of exactly what is in the treatment.
What are the benefits of IVMT?
IVMT is used for a variety of health benefits. Cellular function and physiologic health is restored and supported through the delivery of vitamins, antioxidants, essential minerals, electrolytes and hydration at levels that are impossible to achieve through oral consumption even if the product label is accurate, which in most instances it is not when purchasing over the counter nutraceuticals. Even a healthy diet cannot achieve the serum level of nutrients that can be achieved using IVMT and therefore can provide additional benefits even to those who are eating well.