Scott Polisky and Dr Susan Brienza - regulatory attorneys for Jarrow - have drafted a detailed rebuttal of the claims made in the June 30 article , which re-ignited the debate over how the US dietary supplement industry is regulated and prompted senators to demand answers from the sector’s trade associations.
The Tribune article - which presented the trade as dogged by “serious and widespread manufacturing problems” - claimed that one in four supplement companies the FDA had inspected have received a warning letter.
It also included a quote from the FDA’s supplement chief Dr Dan Fabricant, in which he reportedly said: "It's downright scary… At least half of industry is failing on its face."
FDA’s own data does not show that at least half the industry is ‘failing on its face’
The article appeared to be designed to frighten the public and “encourage Congress into imposing a Draconian, destructive—and totally unnecessary—regulatory regime” on a trade that in fact had an excellent safety record, claimed Polisky and Brienza.
However, their strongest criticism is reserved for the FDA, which said Fabricant's reference to half the industry failing on its face was based on data showing that half of the supplement firms it had inspected had been subject to OAI (Official Action Indicated) or VAI (Voluntary Action Indicated) notices.
But to extrapolate from this that half the trade was in serious trouble was “inaccurate and inflammatory”, claimed the attorneys.
First of all, the companies inspected were unlikely to be representative of the wider industry given that inspections are concentrated on companies most likely to create a risk to public health rather than a random sampling, they argued.
Second, including VAI statistics (in which minor concerns are identified during inspections but are corrected immediately and not deemed to require further action) was highly misleading, as VAI notices did not represent serious violations of cGMP rules, they added.
Finally, the claim that a quarter of inspections resulted in warning letters was not backed up by data either, they argued: “With 450 inspections one would expect 112 warning letters re. GMP violations; and there are nowhere near that number.”
Erroneous claims in original article subsequently repeated as fact
However, the erroneous claim that half of FDA inspections uncovered serious violations has since been repeated as fact by Senators Richard Blumenthal and Dick Durbin in subsequent correspondence with the trade and the media, they observed.
Meanwhile, despite Dr. Fabricant's prediction that it was only a matter of time before there is a major "public health catastrophe" with supplements, “there has not been one in 17 years”, they claimed.
“Any adverse events with Ephedra were due to gross over-use by consumers contrary to explicit label directions…The only catastrophic example in the Tribune article actually concerns a drug, not a supplement, occurred in Panama, and in particular involved an imported food ingredient added to a drug.”
Meanwhile, extrapolating that industry problems are serious and widespread on the basis of one case involving a supplement that contained a toxic amount of selenium was unfair, they claimed.
“The overwhelming number of fine and trustworthy companies that comprise the dietary supplement industry and are irresolutely committed to safety and accountability would welcome strong and appropriate moves by the FDA against truly bad actors, as opposed to repeated false and rash generalizations by Agency officials that disparage the industry as a whole.”
Bold, inflammatory and damaging
Asked whether the article made any valid points, they told NutraIngredients-USA: “Naturally, the overwhelming number of reliable, law abiding and science-driven dietary supplement firms are concerned with those companies which are not in compliance with GMP requirement or otherwise violate the law.
“But unquestionably, the Chicago Tribune article and those quoted - FDA's Dr. Fabricant and Senator Durbin - unfairly damn the entire industry with extrapolations from a few cases, all culminating in a bold, inflammatory and damaging Sunday front-page headline (per Dr. Fabricant's remark) that supplements are "Downright Scary."
Jarrow Formulas' president Jarrow Rogovin added: "The fact that the FDA finds a few bums does not mean that Dick Durbin needs to drop bombs on the rest of us."
A spokesperson for FDA said: "A VAI classified inspection is still indicative of GMP violations and a situation where evidence of non-compliance to 21 CFR Part 111 is documented.”
Click here to read the Chicago Tribune article.
Click on the link below to to read Jarrow Formulas' full response to the Tribune article.