My cousin’s wife is a brilliant scientist who works for a pharmaceutical company. My cousin, indignant on his wife’s behalf, can’t stand the FDA (Food and Drug Administration) especially it’s new-drug approval process. “It is so fricking slow”, he groans. Maybe, he has a point. You see, preapproval for a new drug takes several years. A company has to go through several steps to prove its safety and efficacy.
They have to prove, on their own dime:
- Cell based and animal studies to show it is not dangerous to humans
- Is the manufacturing process reliable?
- Will its components deteriorate while sitting on the shelf?
- What by products are generated when the drug is metabolized?
- How is it absorbed into the body? How is it flushed out?
After all the above is answered, you move on to human trials. You go through phase 1 (few dozen people) and then phase 2 (a few hundred people) and then phase 3 (a few thousand people). And the onus of proving all the above is on the company.
Is this a perfect system? Not really. After all this trial and testing, any new drug comes with a big price tag Most of them being too expensive for the patients. Plus, the companies all look for only the golden goose type of products. For example, when the law tightened around pharma companies in 1950’s, Smith Kline had 15,000 products. They dropped 14,940 of them to focus on the top 60. Talk about a real-life pareto effect!!
BUT, and this is a big BUT…
This is a systematic and thorough way to go about finding if a drug works. Winning drugs save millions of lives around the planet. There is high level of confidence in the safety and efficacy of the drug. Otherwise, you might as well just do guesswork.
Plus it gives doctors the confidence that they can safely prescribe the drug to their sick patient.
FDA- Food and Drug Administration
The FDA is a regulatory agency in charge of nearly 20% of goods in the US market – especially the ones that closely affect human health – mainly food, drugs and cosmetics. You saw the “Drug” portion of the FDA discussed in the opening paragraph. Moving on to the “Food” part of the FDA. Obviously, food that has been eaten for centuries by humans don’t need testing like a drug. Most of the foods qualifies under GRAS – generally regarded as safe. Here, you don’t have to do much – except declare that your food contains x,y,z standard items. For example, I am going to sell cookies, so I declare on the label – wheat flour, salt, baking powder, etc. None of these need to be sent for FDA approval since they are considered GRAS.
But, there are certain food additives like coloring, or preservatives that come under Food Additive Safety Determination, which means that there is an upper limit beyond which these items cannot be used in a food product. For example: if you use sodium benzoate as a preservative for a pickle, then you cannot go beyond 0.1% concentration. And this is good, because you don’t want food companies to add dyes and preservatives willy-nilly.
So far, so good.
What do you think supplements should come under? Maybe it feels like medicine…but you don’t want too strict rules to get just some plain ‘ol Vitamin C.
Or maybe it comes under food. Not so strict, but still have limits for the weird sounding ones.
Actually neither! Supplements are even more loosely regulated than foods are. Is that weird? It all comes down to this guy: Senator Orrin Hatch and his DSHEA act!!
Quick US Supplement Laws Timeline
Here’s how the FDA grew first and then got played royally by the legislators…
1937: A drug called Elixir Sulfanilamide caused deaths for 100’s of people including young children
1938: In response to public outcry, The Food, Drug and Cosmetic Act is passed. A sweeping legislation that gave FDA the authority to regulate food, drugs and cosmetics in the country and punish offenders when found guilty.
But, supplements were left out at this time. You see, vitamins were just getting discovered one by one and synthesized right around that time frame. It was too early for them to be regulated.
1973: The supplement market was booming. People though if 100% RDA is good for me, why not 1000%?The FDA decided to cap the amount of vitamins and minerals in a pill (150% RDA for most vitamins) to prevent overdose problems. Too much vitamins can cause problems too. For eg, overdosing on vitamin A has been proven to cause liver damage, birth defects and sometimes death. Sounds reasonable, no? But the moment the FDA wanted to even remotely regulate the supplement industry, the knives came out.
1974: Rather than tighten the supplement market, a Democratic (!) senator from Wisconsin, Sen WIlliam Proxmire attached a Vitamin-Mineral amendment that would prevent FDA from ever requiring proof that an ingredient was useful or establishing any standardization requirement for supplements. What was their argument? If FDA comes after your vitamins, what next – will they regulate salt and sugar? Like as if FDA did not have enough work on its hands.
1993: FDA decides to tackle labeling claims. They did not want companies claiming that their supplements can cure any diseases, without following any of the processes foods or drugs do. David Kessler, head of the FDA at that time argued “Why should a vitamin D claim on a box of cereal be held to a different standard as the claim on the supplement bottle?” You would think this is a valid statement, you don’t want companies claiming their Vitamin C or Gingko Biloba or Ashwagandha can treat diabetes or cancer, right?
But, of course, in response, the legislators and the supplement industry of this country decided to declare war on the FDA.
First, they flooded the FDA with letters from the ‘public’ (majority of whom were selling vitamins on commission) egged on by the National Health Alliance, a supplement industry lobbying group. BTW, this tactic is not new. This exact tactic of flooding the FDA with letters was used to prevent the FDA from banning saccharin, the artificial sweetener in 1977.
Second, just to ensure that FDA is no longer a threat to the supplement industry, they passed the DSHEA act.
DSHEA – Dietary Supplement Health and Education Act!!
(Tip – Kids, when you become a politician later and you want to weaken an area of law, just make sure you name it the exact opposite way. For eg: You want to cut social security, call it the “Social Savings and Old People Helping Act” or whatever!!)
1994: DSHEA is passed and signed by Bill Clinton! (seriously??, aren’t Democrats supposed to be supporting the federal departments)
With DSHEA they stuffed in as much latitude as they could pack for the supplement industry:
- They grandfathered all dietary ingredients in the market as of Oct 15, 1994, never mind if they have been studied or not
- New dietary ingredients do NOT have to be pre-approved by the FDA. That is right, they don’t even have to go for the Food Additive Safety levels, straight to GRAS level. This is the GRAS loophole that supplement companies can easily exploit.
- The companies need not prove that their products is safe. The onus of proving that a supplement is harmful to the user, falls on the FDA and not the company.
- Post sale, if any consumers report any adverse reactions to the products, the company needs to only report a serious issue like hospitalization or death; unlike drug companies that have to report all adverse events. This reporting feature too was added only later; and not the original part of DHSEA.
So, in conclusion, the DSHEA achieved 2 things.
1) Introduce whatever you want into the market, whether it is actually useful to people be damned.
2) If the supplement is causing problems to people, make it super hard to nail down the supplement as the source of the problem.
Note: I am not saying that the supplements are adulterated. This gets covered under Current Good Manufacturing Principles regulation and hopefully the shop selling you the supplements (like Costco) or the lab testing the supplements (like USP) are making sure the supplements is not adulterated or contaminated.
Anyway, the supplement industry was happy and they grew. According to regulatory focus site: raps.org
“At the time DSHEA was passed in 1994, there were about 4,000 products on the market, with net sales of $4 billion per year.” As of 2021, the supplement industry is 150 billion industry growing at a breakneck speed with an expected CAGR of 8.9%. A whopping 80% of Americans take supplements. Every health trainer or online Insta influencer seem to be selling supplements.
FDA – A paper tiger when it comes to Supplements, except labeling
Senator Hatch was able to reduce the FDA to a paper tiger status when it comes to supplements. The only thing FDA fought tooth and nail and was able to get in place was in the labeling of supplements. They basically said: Folks, if you use the word “cure” in your supplements bottle; then we have to just place you over in the “Drug” category. You are welcome to come there and make all these claims provided you go through all the phases of testing.
Which is why if you turn over your supplement bottle you will see 2 types of labeling language.
1) “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” This is basically FDA’s way of saying – these buggers have tied our hands, so don’t blame us if you develop any problem after eating this product.
2)You will see the words “supports”, “maintains” etc. but never “cures” or “treat”. I watched a webinar posted online by a supplement company. In it, they instruct salespeople to say “look at bone health/joint health section for products” when someone comes to them looking for arthritis cure products. They are not allowed to say “this is a cure for arthritis or any other problem” at any point during the sale.
The FSSAI (India’s FDA) recently came out with Ayurvedic Aahara regulations where they issued labeling constraints on ayurvedic products – a much needed regulation. This would prevent people from getting duped that their Ayurvedic medicines will cure all their problems. Instead, they would use it as a supplement to support their health if and when needed.
However, FSSAI is relatively new organization compared to FDA and they are starting from bottom up. It is sad that the FDA which made great strides during 1930’s go backwards in its regulatory efforts in the past few decades. I get that we don’t want too much Government in our lives. But with too much leeway, we are swiftly going back to snake oil era where pointless products are pushed to unsuspecting public.
There is a need for capitalism when it comes to many products; but the supplement industry can be optimized for more than just maximizing profits, don’t you think? Otherwise it is the wild, wild west all over again!
- US consumers are buying more and more supplements
- The adverse event reporting system is broken
- Congress is currently pushing for reforms to protect consumers
- The GRAS loophole
- The majority of self-GRAS reports—the majority—are garbage,” Bass proclaimed in an interview. “Some are good, but how many? I’m guessing a very small percentage.”
- Book – Vitamania by Catherine Price
It boils down to being a risk based decision, isn’t it. What is the risk associated with non-regulated supplements? How does that compare with other risks that FDA need to manage (and are struggling to already). What is the level of awareness of the risks amongst consumers (and patients) and how much of appetite is there to absorb it? Can other means of interventions such as industry standards be used? Regulations cost tax payers and are not always the best instrument to manage risks. It is best to use them judiciously and where they actually serve a real purpose…
Just some thoughts…
I am surprised by your take. Somehow I thought you might be more sympathetic to the FDA’s predicament.
The costs are very much hidden inside medical costs. Drug based medical problems are clearly provided by the drug manufacturers via doctors. They track all the info. But supplements info including product’s name and ingredients are rarely conveyed to the FDA. There is no system in place to collect it. Millennials are now popping 5-6 supplements a day. It will be unfortunate to wait for a large catastrophe in order to address this issue.
That debate aside, hope all is well :).
I absolutely am sympathetic to FDA’s predicament but am also realistic about the the true value of regulatory impacts. Having seen and worked in the regulatory world for nearly 20 years now, I am quite convinced that the perceived expectations regulatory protection are far greater than what can actually be delivered. Society needs to be reasonable about what to expect and have regulatory systems focus more on the highest risk priorities. Covid-19 was a massive regulatory failure largely because regulators have way too many priorities and are simply not equipped well enough and that is unlikely to change in my lifetime. I also don’t think throwing resources at them would necessarily make a difference. We should explore other alternatives including influencing the use of industry standards that can monitored through independent oversight, use stronger public education campaigns including the involvement of the medical professionals etc.
If you get a chance, do read a book that is going to become available in the next month called Outcome Based Cooperation written by a mentor/collaborator of mine, Dr Christopher Hodges. His research points out to very interesting observations on regulations and how better outcomes can be achieved through more creative/cooperative means.
All good otherwise. Hope things are well.
Some great points there, Srikanth. I will definitely look out for Dr. Hodges book. But, you know very well that while Congress works overtime drafting and un-drafting legislations, it does not lift one finger to earmark budgets for such strong reaching and useful campaigns, right?
Anyway, I hope there are some innovative solutions in the future, other than just letting companies sell A-Z products with no restraint whatsoever. Thanks for chiming in with these insights. These add such value both to me and readers of the site.
I’m glad I could contribute the little bit I know about regulations and quite enjoy your blogs!
Talk about the knives coming out … I want to deputize you to carry mine and use it as required with this same level of vigor!
A GREAT piece containing a wonderful historical perspective supported by lots of FACTS.
Keep it up. This puts you in line to become my favorite blogger.
I thought I was already your favorite blogger!! Haha…😝
Thanks for the feedback. I am so happy you enjoyed it.
Thank you so much for putting up a brilliant informational and thought provoking article.
Thank you Shilpa!!