Intellipharmaceutics International Inc. (IPCI)

[Despicable_Z]

He's going to come back and claim that the dye can be absorbed in people with GI irregularities or conditions such as crohn's, IBD, sepsis, ulcerative colitis, etc. Which even if moderately based in some shred of fact, doesn't nearly outweigh the current opioid epidemic overdose deaths, and could be selectively not prescribed to individuals with those known GI issues (if this was even deemed to be a worthy concern).

From (2003)- As this is over 13 years old and it is still an approved inactive ingredient guess they didn't find a whole lot else to it:
http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InMedicalDevices/ucm142395.htm

While we are not able at this time to establish a cause-and-effect relationship between the reported serious and life-threatening patient outcomes and the use of the dye, nonetheless, given the seriousness of the potential complications, we believe health care professionals should be notified of these reports.


A causal relationship between systemic absorption of Blue 1 and the reported serious and life-threatening patient outcomes (including death) has not been definitively established.

As background, FD&C Blue No. 1 is a water-soluble dye allowed by the FDA for use in foods, drugs and cosmetics, based on numerous studies in animals. Data from life-exposure animal studies supports an ADI (acceptable daily intake) of Blue 1 of 12.0 milligrams/kilogram body weight/day. The dye is batch certified by the FDA and is widely used in food products (candies, confections, beverages, etc.) in amounts consistent with good manufacturing practices (generally at parts per million).

Yeah... I bet AdCom is just going to demolish this approved substance. lol.