Nowadays the number of warning letters you will get issued for misbranding.
Let us discuss WL # 619877
The Food and Drug Administration (FDA) reviewed the product labels.
The claims on the product labeling establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Under the category “Diabetes Problems Assistant”:
“Powerful combination of two formulas designed to help stabilize blood glucose problems and help maintain regulation of your metabolism thereby reducing the need for insulin and helping to regulate blood sugar levels . . .”
The product label image in the catalog states “Natural Antibiotic Qualities.”
“Helps with infections such as influenza…tonsillitis, flu, and respiratory system conditions. This supplement with natural antibiotic qualities of wide spectrum [sic] is effective against many bacterial processes.”
“Helps in infections like:
o Influenza
o Anginas
o Flu
o Diseases of the respiratory system”
As per the USFDA products are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)].
With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].
FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
There are many observations and non-compliances.
What do you conclude from this?
The conclusion is that without having scientific data & evidence one should not claim anything about the drug which is not actually reality.
Now check that in your case, you are writing label claim on your drug whether are claimed with scientific data?
Otherwise, instead of commercial gain, the company will have to suffer from non-compliances issues and some cases enforcement actions.
There are many types of non-compliances. May be due to ignorance or maybe due to other reasons.
I have discussed many in my book Blue Ocean of Compliance.
You may avoid many by reading this book.
Do not miss to read it.Click the link to book your copy of Blue Ocean of Compliance today