Are Supplements Regulated in the USA?

November 15, 2019 11 min read

Do Other Governmental Bodies Have Better Systems?

Since our "hydrogen tablets" to create "hydrogen water" are sold within the supplement and food space, we get significant criticism from skeptics. It is automatically assumed by many skeptics that "all supplements are bogus" and "supplements in the USA are not regulated." While this is not true in terms of the laws governing the industry, it is often true to terms of enforcement. Regulatory compliance in the USA tends to be an "opt in" system, opposed to other bodies which are more active in forcing compliance, such as Canada, the EU and Australia. However, issues in the bureaucratic processes. Skeptics often have have a completely invalid and misleading understanding of how the opt in compliance works, as I detail in "is New Dietary Ingredient Status Significant?" and often the positions of the "bad actors" in industry overshadow the voices of those petitioning for more enforcement, who have ensured compliance.

Is the FDA Easier on Supplements That Other Countries?

There are pros and cons to the way the FDA handles supplements. In many ways, the FDA is easier and in many other ways much, much harder then the governmental bodies previously mentioned. Much of how the industry is built and governed comes down to political ideology, layers of bureaucracy, and priorities in funding. These are institutions of both thought and law that are hard to amend, regardless of the regulatory authority being looked at. Some of the key differences are handled below:

Good Manufacturing Practices Certification (cGMP), Private vs. Government Auditing

We use manufacturing in the USA and Canada, so we are aware of the differing systems. Also, we have toured north of 1-- contract manufacturers between the two countries and gone through both regulatory processes. Health Canada tends to get a better reputation and has more bodies granting it equivalency. For instance, Health Canada and the Australian TGA, notorious for being the strictest on the planet and a hellacious endeavor o get approval in the US facility or from a US product, have an equivalency agreement. Meaning, if Health Canada is OK with something, it is a fast track for TGA approval, and vice versa.

While Health Canada will audit facilities and maintains the right to do so, the frequency it happens is not consistent. That said, when audits occur they are often by surprise and if any large issues exist, a facility may be immediately shut down, losing their site license. In the USA, the FDA almost never audits a facility, only doing so when they are moving in to take enforcement action after gathering sufficient evidence to know a manufacturer is in violation of laws and likely endangering the population.

In the USA, manufacturers more frequently turn to third party Good Manufacturing Practices (cGMP) auditors, such as NSF. In countries such as Canada, manufacturers will often additionally get NSF certified, predominantly for marketing purposes. While these audits are potentially more detailed, they are schedules and the date of the audit is known well in advance. This gives manufacturers the chance to put their "best foot forward", without the risk of being caught on a "bad day". Additionally, manufacturers can repeatedly "fail" their audits, and so long as they address the failures in a written report explaining how they are amending them, they will continue to be allowed to claim "GMP certified".

This tends to be a large issue in the industry and is why many brands are constantly looking to find manufacturing improvements. It is also why once brands have a good manufacturer, they tend to protect the relationship, as it is as (or more_ important than their distribution and customer base. On the flip side, manufacturers will do their best to keep large groups pf consistent customers happy, as it is those large customers and the work they bring in that allows them to maintain high levels of uniformity, compliance, and high quality.

Big Manufacturers vs. "Mom and Pop"

One interesting comment I have heard repeatedly is customers prefer buying from small manufacturers or brands as they "trust them more" than large national brands. In pressing reasoning, I have heard repeated suspicions that larger brands are not providing quality, or sufficient ingredients and "skimming" or that products may not be made with "care". To me, having toured many facilities and worked with dozens of brands of all sizes, this is an absolutely bizarre and incorrect position.

In my experience, the smallest manufacturers have the worst controls, the least qualified quality control (QC) people and the worst equipment to maintain consistency. They are often also the most likely to allow something slide as they have less to lose, so to speak. A failed run makes up a far larger percentage of their bottom line and as such, finding a way to make it work is far more important. With larger facilities, a single failed run for a customer is much less of a big deal and can more easily be rectified at a far smaller hit to their bottom line. Additionally, the news of any GMP practice indiscretions stands to lose them far more if larger brands with stricter QCs find out.

Similarly, big brands tend to have a lot more on the line than small brands, and also have far greater organization, controls, and internal QC. As a company that self-regulates having earned a no objection from the FDA as a New Dietary Ingredient (NDI), I know the work that must be taken to ensure compliance. As a company that both manufacturers for our own line and provides product for many brands utilizing our intellectual property (IP), I have firsthand witnessed the requirements of companies of varying sizes. I can say with 100% certainty that larger brands have significantly greater controls in place. In fact, often the larger bands are stricter in meeting their compliance than the FDA's rules or the requirements from audits of organizations, such as NSF. As we have started dealing with major national and multinational brands, we have had to "up our game" in many ways, creating even tighter controls than required by third party GMP issuing bodies, the FDA or Health Canada, etc. Perhaps it is the target on their backs and litigation friendly culture driving this, but in my experience, the larger the brand, the better the controls.

Large brands and large facilities may get more skepticism due to media coverage. It isn't news when a small brand that no one has heard of or a small facility employing a dozen people is found to have violated health codes or otherwise done something unbefitting of quality and safety. If a mistake happens in a facility distributing nationwide is a large "household" brand, it is national news. The big brands understand this and understand that the larger they are, the bigger target they are for litigation and attacks on practices. This knowledge and fear of complications is apparently a stronger motivator than governmental auditing.

I want to make it clear that smaller brands often will behave as if they are large in their quality controls. They create a culture of compliance from day 1 and work at it. It is something we have done and try to do, improving our knowledge and practices each passing month and year. I'm sure some big brands take more risks and are laxer, however, doing so is a larger risk and more likely to lead to consequences. While many small brands operate completely ethically, many others know that their size means they are flying under the radar.

Health Claims

In comparing the current models of both the US FDA's stance on health claims of supplements and that on the approval of health claims by Health Canada, both are flawed and have rather erroneous conclusions from proponents and critics. Furthermore, both regulatory frameworks are in the process of being updated by their respective bodies.

Supplements in the USA

With the FDA, supplements MUST put a disclaimer that claims they have not been reviewed by the FDA and are forbidden from making any claims to treat or cure an illness or disease. Even more innocuous claims not intended to treat, diagnose or cure a disease can come under scrutiny. This position leads to skeptics declaring that supplements cannot make claims and such as do not work. Others state that because they cannot make claims, have not submitted evidence of efficacy, and have not proven efficacy as reviewed by the government, these products should not be sold.

Bad actors in the industry will utilize this regulatory position and sell things they know to be inefficacious, as they do not need to prove the product works to sell it. Simply because a product does not have to shown to work, and bad actors exist that push products that do not work, does not mean that no products in the space have benefits.

Critics of the industry will often cite that the supplement industry is lobbying to not be enforced. This is not true, at least not in an absolute sense. Many others I have spoken to in the supplement and natural industry mimic my concerns. They want the FDA to enforce against bad actors causing issues. They want their companies that work in opt-in compliance to be protected against those skirting the law and undermining their efforts. They want claims of efficacy to be enforced. For instance, i've spoken with John Venardos, VP of Regulatory Affairs from BodyBuilding.com, on this in the past and he has spoken publicly about industry lobbied efforts to have the FDA utilize more resources to go after bad actors. Many others in the industry echo my sentiments. In my case, there are three unregulated products using similar technology framework we have. We are compliant in every governmental agency we believe we are required to be and need to consider laws and requirements of each. As such, we need to maintain legal and consulting experts retained in all areas, 8 agencies in the USA alone, a task which over doubles our operating costs. Compliance is expensive. Those who comply what the government to enforce compliance.

Similarly, many companies in the USA maintain programs conducting clinical work to demonstrate efficacy in the products they sell. We at Drink HRW have an active clinical outreach program, having three published clinical trials and a case study using our hydrogen tablets to create hydrogen water in the three years of existence, with another larger trial and case study finished. We also have 7 other trials underway, half a dozen others in planning. These are all conducted under no publication agreement as we are seeking the truth in how and when our product is effective. Already we have caught products delivering as low as 1/100th the dosage adversing our trials as benefits of their products. This is a massing disincentive to conduct this type of validation work, and other companies maintaining integrity and acting as we are, typically feel the same. Companies complying and pursuing scientific validation need to be more protected and it is imperative in improving the US system.

Supplements in Canada

Supplements in Canada are subject to a quite bizarre set of regulatory processes that give an air of credibility while causing massive costs in the system and bottlenecks. I am all for impartial auditors to review and approve health claims. That said, I am vehemently against the system Canada has in place.

The Good:

  1. To have a Class lll license issued in Canada, two clinical trials showing a similar benefit on an exact product must be provided. A Class lll license is required for new ingredients or combinations of active ingredients not previously registered.

The Bad:

  1. Products can get function claims based on pseudoscientific textbooks, such as books on homeopathy.
  2. Anecdotes from users can be used for approved claims if a product has been in use across several generations.
  3. Quality of the studies used is not considered.

The Canadian system allows for homeopathic products to be marketed on pharmacy shelves along with over the counter drugs that have proven to be efficacious. This is misleading and gives an air of legitimacy. It creates confusion in consumers, believing products without proof of efficacy, or worse, significant evidence of no benefit, to be marketed as "equivalent" alternatives to proven care. Science Based Medicine talks about this and the proposed updates to Health Canada's regulatory process here.

I do not always agree with them, as evidenced by my rebuttal a few weeks ago to a very poorly researched article on hydrogen water they wrote, but in this case I agree with Science Based Medicine's criticism of the Canadian Health Food Association (CHFA) whining about potentially losing the underserving advantage og unsubstantiated claims. I don't quite like the proposed changes, and would argue that more tiers are needed. Low risk products should also have tiers of evidence submission. Currently, two publications are needed to apply for claims. I believe this is a good standard but would add that the trials used to request label claims should maintain certain standards, such as requiring to be placebo-controlled, randomized and double-blinded. They should also have at least ~20 participants each, or perhaps lower, such as 12, if they are of a crossover design. Products not meeting this standard should have a disclaimer actively stating "no submitted evidence exists to proved a claim of benefit on this product", rather than the FDA statement that they have not evaluated the claims. Issued claims should be suggestive and not definitive, such as "may", "potentially benefit", similar language to what is allowed in the USA with no proof.

Notification & Approval

Please see last week's article on Notification and why NDI status means something here.

Why We Choose the Supplement Route Over the Drug Pipeline

Even in the case of our hydrogen tablets that generate significantly higher dosages than other hydrogen water technologies, I do not believe our product fits in the drug paradigm. This is despite self-funded research teams using hydrogen water created by our tablets in clinical trials for various diseases and benefits of hydrogen water and/or inhalation of saline being potentially beneficial in numerous models. Many of these trials have required investigational new drug (NDI) applications, something that can be obtained while we market asa supplement only because we have successfully gained NDI status.

The cost to launch as a drug be as "low" as $100 million, but recent estimates have pegged the average cost as high as $2.5 billion. As I spoke about earlier in this article, the regulatory compliance we undertake already doubles our cost of operations and goods, and the $1 million we spent to launch combined with those high regulatory costs and ongoing investment into growth, compliance in other areas of the world, product improvement and clinical data already puts us priced as a "premium" supplement. Going down the drug pipeline would mean our product would only be available by insurance for those that are prescribed. Considering the wide range of applications that hydrogen water can potentially assist in, this would not only be a foolish move, but an unethical one.

Moreover, as discussed in my open letter regarding testimonial here"to be frank hydrogen water may never be successful in the drug pipeline as it would need to be targeted for a single and specific indication. The mechanisms of action and outcomes of hydrogen water administration are significantly different than that of what we terms to be drugs and their specific targets." Hydrogen water, or hydrogen therapy in general, appears to have a rescuing effect, perhaps working as an incredibly safe and well-tolerated form of hormesis. The costs to get the product approved as a drug may be well above $2.5 billion as each benefit for each model would need to be addressed.

There are tiers of evidence and tiers of risk. The statement that a product lacks the proper evidence to make it through the drug pipeline to treat a specific indication is not proof that it has not benefit. Properly validated supplements should be products with high evidence of safety, that display reasonable evidence of some efficacy. This is not an absurd concept, many things such as exercise and a healthy diet are undoubtedly good for you, while typically not being a replacement for medication for many diseases. In other models, they are the first lines of defense and used as adjuvant therapies. Supplements can exist in this space, but need better enforcement against the bad actors and protections for those compliant.


Leave a comment

Comments will be approved before showing up.

Subscribe