Op-ed: Why an FDA Overhaul of Dietary Supplement Industry is Critical

[kasa_balavu]

https://today.uconn.edu/2019/02/op-ed-fda-overhaul-dietary-supplement-industry-critical/

Op-ed: Why an FDA Overhaul of Dietary Supplement Industry is Critical

Federal Drug Administration Commissioner Scott Gottlieb, recently proposed several regulatory and communication initiatives that he said would lead to “one of the most significant modernizations of dietary supplement regulation” in nearly three decades.

The dietary supplement world is a murky place where you spend your money on a product that may or may not have any active ingredient in it, may not contain the promised dosage or concentration of the active ingredient, or it might include adulterants and contaminants.

I have read and written about many examples of this.

For example, some natural products for male enhancement, muscle building, and weight loss that have been adulterated with unlabeled prescription drugs, including those banned by the FDA because they have been proven to be unsafe. In addition, the dietary supplement Kava had been considered safe for years before cases of liver toxicity suddenly started popping up, leading to worldwide restrictions and cautionary messages from the FDA. Kava didn’t suddenly become more dangerous; what likely occurred is that its growers started substituting a variety of the plant that grew faster to create greater yields, but the locals knew they should never use for medicinal purposes.

The list goes on: some K@ products contain a far greater concentration of 7-hydroxymitrogynine than would occur naturally, leading to suspicion that it is enriched with a chemical that has stronger opioid effects and addiction potential; some cannabidiol products had only 12.5 percent of vaporization liquids, 25 percent of tinctures, and 45 percent of oils labeled correctly (plus or minus 10 percent of the labeled value). In most cases, these products contained far less cannabidiol than promised, and some cannabidiol products contain enough THC to put the user in legal jeopardy of marijuana possession. Some dietary supplements have been shown to contain excessive amounts of cancer-causing polycyclic aromatic hydrocarbons and contaminants such as heavy metals and mold.

How many more debacles must occur where the public trust is shoved aside to make a quick buck before people turn their back on natural remedies? The FDA can take decisive action that can reduce misinformation, fraud, abuse, and unintentional poor cultivation and manufacturing practices. This can enhance the safety of dietary supplements sold in the U.S. and actually sustain this marketplace over the long-term.

No dietary supplement should be touted to prevent or cure any disease. Using a mouse study, in vitro cell study, or case report to market a dietary supplement’s disease-modifying effects is fraudulent and hurts the public’s trust.

The FDA already has guidance on good manufacturing practices, but following them is not compulsory before placing a dietary supplement product on the U.S. market. Manufacturing plants, including those overseas, need to be personally inspected by the FDA. We know from the generic drug market and now the debacle with angiotensin receptor blocker manufacturers that the FDA’s history of inspecting foreign manufacturers is poor. Furthermore, all products should be tested periodically by an outside lab certifying that the products are free from contamination and adulteration, while possessing the promised dosage of the active ingredient, before it is allowed to be sold, and randomly checked periodically thereafter. This would protect consumers and put the onus on the final manufacturer to ensure the quality of the products they are receiving from other cultivators or manufacturers. All of the costs of this outside testing should be borne by the manufacturers, plus a surcharge to pay for additional FDA inspectors overseas. The current system where an overwhelmed FDA tries to fit in oversight of dietary supplements has to change.

Commissioner Gottlieb’s most recent proposal is sound and would go a long way in ensuring dietary supplement safety, but the agency will need a marked increase in resources to bring it to reality.

 

[Gourmet Hawaiian Kava]

Thanks for posting this, the part about kava is interesting. I can't wait till kava is in the codex of the WHO. Thanks again for the post. Aloha.

Chris

 

[Zaphod]

While the sentiment is good, all roads to hell are paved with good intentions. What typically happens when the government gets involved in things like this is they tend to over react and default to the most conservative position. Cries of save the children will rise up from the suburbs from the soccer moms and next thing you know the only way to get kava will be from a large multi-national conglomerate that has multiple massive GMP factories and everything coated with 10 layers of pesticide. The small guys will be unable to make a living off growing on small farms. In fact, they will take it one step farther and you won't be allowed to even grow your own and if you do you will be thrown in jail for growing a plant. Don't forget to add the tax for all of this. You see to pay for all this new regulation they will now want to add a "dietary supplement" tax. We will all be learning crypto-currency and buying kava by bitcoin on darkweb sites just so we can relax in the evening. kavabay.com here we come....

 

[Zaphod]

Thanks for posting this, the part about kava is interesting. I can't wait till kava is in the codex of the WHO. Thanks again for the post. Aloha.

Chris

Can't agree more. Time to move it out of the "dietary supplement" and into the "food" category as quickly as possible.

 

[Zaphod]

Case in point:
https://thehill.com/opinion/healthc...th-and-safety-impose-a-two-year-moratorium-on
From the article the cry to "save the children":
"We would want a definitive understanding of the effect pot has on everything from driving impairment to workplace performance and learning development in young people."
"Researchers could explore the relationship between marijuana and vulnerable population groups including adolescents and their susceptibility to Juul-like products and sales pitches."
"...as many clinical studies indicate that pot is not as benign as many would like to believe and can be addictive as well as potentially harmful to the developing teenage brain."

As if the youth of america have not been smoking pot for decades...what a crock of horse manure.

 

[verticity]

Here the FDA Comissioner's press release that that op ed is referring to:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631065.htm

It's a bit short on detail, and does not specifically mention kava (probably a good thing). These are the main points I glean from it:

• He mentions an intention to increase enforcement against supplement sellers who make illegal health claims (specifically mentioning actions against companies who claimed their products could cure or treat Alzheimer's disease)
• He intends to communicate with the public better by developing a "rapid-response tool" for product alerts. It's unclear what that means: a smartphone app? a web site or twitter account?
• They will develop new guidance to encourage companies to submit new dietary ingredient notifications (as opposed to just selling products without doing that). Again the details are unclear. It sounds like it just means they are talking among themselves about how they wish more companies would submit these forms? They will have a public meeting about this in the spring..
• They will issue more warnings about stuff, such as ones recently about products with too much caffeine and illegal "male enhancement" products...
• They will "engage in public dialog around...steps to modernize DSHEA [the 1994 Dietary Supplement Act]".. which of course will involve talking to "stakeholders."
• They will create a Botanical Safety Consortium with scientists from "industry, academia and government." It will do research about safety testing and toxicology, but the description is kind of vague, and no specific people are named as being on it.

So, sure, those things all sound reasonable, but they also sound like things that the FDA already does. All I really get from that is "we, the FDA, will try to do a better job at the things we are already supposed to be doing, and we will make an app or something to communicate better and form some committees to talk about stuff." I don't get any sense of a really significant change in policy.

So, it is fair to ask, who is this guy, FDA Comissioner Scott Gottlieb?

He is a conservative doctor who was appointed by the current president. He has close ties to pharmaceutical companies and health care companies. He is generally considered a moderate who was better than some other more extreme people the president might have appointed, but there was a lot of concern from many during his confirmation about aforementioned close ties to big pharma:
https://www.nytimes.com/2017/03/29/health/fda-nominee-scott-gottlieb-recuse-conflicts.html

My own take on him is that he is not the worst, but I don't entirely trust him either. I'll actually be fine if he continues to just make feel-good speeches, yet maintains the status quo, rather than actually trying to bring about radical reform (which it does not seem he really is despite the op-ed author in the OP reading his hope for that into Gottlieb's statement...).

 

[SelfBiasResistor]

Gottlieb is hardly a moderate. So far he's proven to be a man on a mission to go after the pharmaceutical industries competition. He continually makes factually inaccurate public statements and is more interested in banning herbs than he is in science or public health/safety. There aren't many details given at all in his announcement but it's clear he wants the FDA to have far greater power over the supplement industry. The writer of that opinion piece is right about the problems with impurities, adulteration and mislabeled products being common place in the market but giving the FDA more power isn't the answer. With some research and education consumers already have access to safe and effective supplements and herbs. As @Zaphod mentioned more regulatory power will result in higher prices for consumers and a smaller market dominated by large companies selling lower quality products than what we have now.

Can't agree more. Time to move it out of the "dietary supplement" and into the "food" category as quickly as possible.

If and when kava is moved into GRAS status it won't really give it that much more safety in the marketplace. It still won't be considered a food item and GRAS isn't necessarily permanent since it can be taken away.

Quote from the article: "Kava didn’t suddenly become more dangerous; what likely occurred is that its growers started substituting a variety of the plant that grew faster to create greater yields, but the locals knew they should never use for medicinal purposes." IMO it's not fair to cast the blame on the Vanuatu farmers by suggesting that they purposefully sent a known toxic substance to foreigners labeled as medicine that resulted in deaths. It's too bad there has been so much confusion caused by a group that has continually stated opinions and theories as facts.

 

[Gourmet Hawaiian Kava]

Quote from the article: "Kava didn’t suddenly become more dangerous; what likely occurred is that its growers started substituting a variety of the plant that grew faster to create greater yields, but the locals knew they should never use for medicinal purposes." IMO it's not fair to cast the blame on the Vanuatu farmers by suggesting that they purposefully sent a known toxic substance to foreigners labeled as medicine that resulted in deaths. It's too bad there has been so much confusion caused by a group that has continually stated opinions and theories as facts.

It has been found that a certain company that made kava pills for the German market got makas, kava stalks and leaves and things like that. It was found that a certain extraction of these items was to blame or to be safe most likely was to blame. This is why there are strict rules in Germany now to make kava pills. The Vanuatu people were not directly to blame but as a kava farmer, I only sell the parts of kava that are traditionally used and only the varieties that are known to be every day drinking kava.
All of this is known, that is why the German court lifted the ban that used to be in effect. I posted this just for clarification.

Chris

 

[Intrepidus_dux]

While the sentiment is good, all roads to hell are paved with good intentions. What typically happens when the government gets involved in things like this is they tend to over react and default to the most conservative position. Cries of save the children will rise up from the suburbs from the soccer moms and next thing you know the only way to get kava will be from a large multi-national conglomerate that has multiple massive GMP factories and everything coated with 10 layers of pesticide. The small guys will be unable to make a living off growing on small farms. In fact, they will take it one step farther and you won't be allowed to even grow your own and if you do you will be thrown in jail for growing a plant. Don't forget to add the tax for all of this. You see to pay for all this new regulation they will now want to add a "dietary supplement" tax. We will all be learning crypto-currency and buying kava by bitcoin on darkweb sites just so we can relax in the evening. kavabay.com here we come....

What if the FDA funded part or all of the third party testing? Maybe they could fund a percentage based on company size and profit. Third party testing seems like the most reasonable answer to me, just we need to pay for it.

 

[verticity]

For those of you old enough to remember Gilda Radner.... never mind!

FDA chief Scott Gottlieb planned sweeping changes, but leaves with most unfinished