mdi ConsultantsGFda Information Artical
FDA Says A BIG NO. Find out WHY
Background and some few Clarifications of some definitions by FDA:
Dietary Supplement:
A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet which includes: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. They can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. In whichever form they are, they are marketed as “foods” and not drugs.
The Million Dollar question and FDA’s Rationale behind that:
Our Research and the FDA reasoning behind this:
From our research and dealings with the FDA, apparently, dietary supplements being administered on an Oral Strip would not be considered by the FDA as a dietary supplement.
FDA’s reasoning:
According to the FDA, Oral strips are thin film drug delivery system, administered through mouth that enters our blood system via absorption. They are the advanced alternatives for tablets, capsules and liquid dosage form. This delivery system allows the drug to bypass the first pass metabolism and enhances its bioavailability in the blood.
Thus, the overseeing of FDA of an Oral Strip delivery system is not considered as a food but a drug.
Findings of the FDA from the past inspections and its verdict:
FDA conducted an inspection for dietary supplement manufacturing and distribution facility and found out the following observations:
The firm provided misleading direction for use information. As per the regulations, dietary supplements are products that are intended for ingestion and the company’s product was intended to enter the body directly through the mucosal tissues, which contradicted the dietary supplement definition.
In other case the drug was marketed as a dietary supplement that contains an article that is approved as new drug, which according to the regulation was not allowed. So they were accused of misbranding.
Moreover, some drugs were marketed as dietary supplement in spite of being excluded from dietary supplement category according to the FDA regulations.
Lastly, drugs were claimed to mimic the effects of recreational drugs whereas dietary supplements are products that are intended to supplement the diet. Thus, contradicting dietary supplement definition.
Example of the verbiage used by FDA for one of the companies who came into trouble:
Be careful, be wise!!!
Summarizing the whole article, it can be concluded from the above observations and excerpt that if we think we are smart, FDA has always proved to be smarter. It is clearly evident from the above findings that FDA has different opinion on use of oral strips delivery system as dietary supplements. If you think there are other people out there in the market doing the same thing that you want to do and you are entangled in the FDA regulations and overview of your products, they are definitely doing something wiser.
There is a very thing margin between drugs and dietary supplements when it comes to oral administration and it should not be interchangeable, moreover thisbecoming difficult when the labeling of dietary supplements claim that “These statements have not been evaluated by the FDA” and then it is the FDA who gives a red signal to the companies.
If you want to market your product as dietary supplements you have to be updated about all regulations of FDA and be careful with the dosage forms, claims and the regulatory framework laid down by the FDA.
?Email us at info@mdiconsultants.com for discussing more about in depth Regulations for dietary supplements by the FDA about Oral Strips and other products and ref: Oral Strips as dietary supplements