Notification and Why NDI Status Means Something
In a very odd perversion of the New Dietary Ingredient Notification (NDIN) process, some popular skeptic groups have taken up the stance that dietary supplements simply have to "notify the Food & Drug Administration (FDA) within 75 days of launch", slap a label and a FDA disclaimer and sell without any restrictions. As I write about in my open letter regarding testimonials, "as a not for skeptics who parrot this laughable false statement," I will quote Sam Harris's rebuttal to Deepak Chopra regarding physics.
"I would never be tempted to lecture a room full of 1000 people at Cal Tech on Physics. I'm not a Physicist. You're not a physicist.. and basically every sentence demonstrates that."
In reality, the NDIN entails rigorous review and complete compliance of everything relevant under Title 21 of the Code of Federal Regulations. Furthermore, significant safety data and evidence of human use is required. While the FDA no longer rules supplements "safe" under the Generally Recognized as Safe (GRAS) process, it befalls on companies to evaluate the safety themselves, which the FDA verifies and either objects or does not object.
"Information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such new dietary ingredient will reasonably be expected to be safe. FDA reviews this information to determine whether it provides an adequate basis for such a conclusion. Under 21 U.S.C. & 350b(a)(2), there must be a history of use or other evidence of safety establishing that the new dietary ingredient, when used under the condition recommended or suggested in the labeling of the dietary supplement, will reasonable be expected to be safe. If this requirement is not met, the dietary supplement is considered to be adulterated under 21 U.S.C. & 342 (f)(l)(B) because there is inadequate information to provide reasonable assurance that the new dietary ingredient does not present a significant or unreasonable risk of illness or injury."
So How Difficult is it to Get a no Objection From the FDA as an NDI?
Since January 2018, there have been a total of 55 submissions. 17 have received a no objection and New Dietary Ingredient status, including our hydrogen tablets as NDI 1104 (the most recent published). Due to significant safety concerns or insufficient data, 28 have been objected and 10 have been withdrawn, presumably before they could be objected. That's a 31% success rate for the companies that bother to attempt compliance, meaning 69% are rejected. According the Steven Tave, an official for the FDA, it is estimated less that 25% of companies requiring to submit an NDI have bothered to do so. That would put the actual percent of compliant manufacturers at below 8%.
Historically, success rates have been even lower. In 2015, Hank Schultz of Nutra Ingredients, USA (who wrote about our product and successful NDI here), wrote an article determining that 88% of submitted NDI's were rejected by the FDA. At the time, many companies were using the self affirmation of GRAS process as a workaround, a strategy that had been talked about since 2012 to combat high failure rates in the NDI process, much higher than GRAS, despite language suggesting it may be less stringent. This workaround strategy is something the FDA silently removed as a strategy in updates to DSHEA in 2016 (DSHEA is the Dietary Supplement Health and Education Act of 1994).
Considering the standards are supposed to be similar in determination of safety, it is peculiar that the FDA has been far stricter in rejecting NDINs than GRAS notification. Coupled with the fact that food ingredients are able to self determine GRAS legally, whereas dietary supplements are no longer able to do this and the evidence would suggest that dietary supplements are held to a higher standard of safety than food products.
Mandatory Rules Used Against Industry
Skeptics and critics of the supplement industry will often use the mandatory FDA disclaimer as a point to attack supplement marketers, mocking that they just need to "slap a disclaimer on the label and sell away." Further, they will often discredit any studies or body of evidence to support a product as not approved by the FDA despite the fact that the FDA does not evaluate claims on supplements. Supplements marketers are left fighting circular logic against these attacks, as the FDA's decision to not evaluate claims os both used to discredit the product and body of science.
In next week's article, I talk about potential solution for finding a reasonable middle ground regarding health claims. As for the supplement market in the USA, while claims are not "approved" by the FDA, even if a marketer notifies the FDA they are making the claims (and the FDA can provide a no objection or object), the FDA and Federal Trade Commission (FTC) can go after structure function or health benefit claims if they do not have proof to validate. Meaning a supplement company can legally make the claims, the FDA can acknowledge the evidence exists to nullify any attempt at action or enforcement against the claims, but the FDA has not approved the claims". Rather than being taken as a tacit endorsement of the health claims, skeptics will bemoan that the claims are not approved and simply not enforce on, making it seem as if the supplement companies are "getting away with breaking the rules."
The FDA fully understands the implications of their rules, and the process of "not objecting" is likely a strategic one. They're allowing those who are within the law to continue on without any immediate fear of repercussions, so long as they remain compliant, while leaving themselves wide open to take action if the situation changes. It allows for more swift enforcement without the issue of "it was approved" hanging over them.
Bizarre Notification Process in Canada
The Class lll notification process in Canada is both ineffective in streamlining business and ensuring safety and validity of claims. It is more bureaucracy than it is safety and scientific evaluation and the end result is products getting to market claims they may not deserve, so long as they've checked the right boxes, and others long deserving of being on the market stalled out stuck in the time hole of bureaucratic paperwork. Where the FDA evaluates each portfolio to make sure a products is safe, has a basis of use in humans, and a company complies with everything pertinent in the Code of Federal Regulations 21, in Canada, evaluators are mostly checking boxes. As we will discuss next week, the burden of proof to receive "claims" is much lower than most corporations within the USA allow themselves for structure function, and the Government issues them to freely use.
The process in Canada is burdensome with backlogs growing longer every year Compendial applications in which a product, saya vitamin C supplement from an approved source using an approved dosage with approved claims but simply a new brand has moved from a 5-10 day turn around time to 60 days. Rejections are typically from a typo or something otherwise easily amendable, but the process requires companies to start over.
For Class lll applications where a new ingredient is being utilized or a combination of ingredients not before used is being applied for, the process is long and tedious, usually taking over 7 months instead of the 75 days the FDA required, and less information is needed to be submitted. The rules are often at odds with scientific fact as well. For instance, if using a molecule that has had claims approved when extracted from substance "x", but the same molecule has been extracted from substance "y" instead, clinical data must be provided that extraction "y" is equivalent. In some sort of homeopathic chemistry belief, the bureaucratic proceeding believes every process in how a molecule comes to be is pertinent for the function claims, regardless if it is the same . purity and dosage. I understand proving that an extraction process is safe, however, that evidence is not what is required. It is "published evidence." a position lightly defined to include such "evidence" as homeopathy textbooks and 100-year-old publications.
The Bottom Line
Other bureaucracies tend to prefer Canada's bizarre and ineffective bureaucratic process. If something is tedious and complicated, it must be effective, right? In the same breath, the NDI process in the USA is often decried due to inconsistencies in evaluation and the false belief that supplements are "not regulated." In the USA, human reviewers make judgements on the evidence. In Canada, even if a reviewer wants to approve a product, if it misses some irrelevant check, whether it be a metaphorical one or a literal checkbox, an application must be denied. The US system is, of course, less "fair", but in my experience much more reasonable and utilitarian. Where the US system is open to more mistakes, the Canadian system willfully allows many products to gain credibility with undeserving claims, all the while stifling business and progress. Personally, I tend to side with the US system. That said, both need serious reforms. Both countries are also proposing reforms. More on the regulation of supplements and potential solutions, next week.