Well Being: Dietary Supplements

and why Pharma lobbyists want more regulations

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute that regulates herbal and dietary supplements (vitamins etc.). The act exempted supplements from most FDA drug regulations. Thus, supplements can be sold and marketed without having to undergo clinical trials or regulatory approval. This legislation has created a large industry that largely excludes big pharma companies. Needless to say, the pharmaceutical industry has been working to amend the DSHEA act to make it more difficult for such products to make it to the market.

One way they are doing this is by setting up companies, such as the Consumer Healthcare Products Association (CHPA) that are lobbying to have the law amended. The Consumer Healthcare Products Association, which does not list itself as a non-profit, cloaks itself in the robe of being all about consumer safety, as it lobbies both Congress and consumers to buy into the idea that the DSHEA Act needs reforming. I find this effort to be disingenuous at best, and I suspect that the real reason that the CHPA wants the Act reformed is for its own financial benefit and that of its sponsors.

The Consumer Healthcare Products Association (CHPA) board of directors includes a who’s who of pharma executives from companies such as Bayer, Sanofi, Procter and Gamble, Colgate-Palmolive, Nestle and many others. The CEO is Scott Melville, whose prior jobs included positions at Sterling-Winthrop, Hoffmann-LaRoche, and Cephalon. Their membership rooster includes just about every large pharma corp that is involved in medical devices, over-the-counter manufacturing or consumer products. They employ at least one lobbyist.

CHPA wishes to create :

“a modernized regulatory structure will protect public health and reinforce the credibility of the dietary supplement category, allowing it to play a more influential role in the healthcare system.”

CHPA describe themselves as providing:

“essential value to our members in the OTC medicine, dietary supplement, and consumer medical device space.”

Right now, large pharma can not dominate the herbal and dietary supplement market, in contrast to their ability to dominate the market for other over the counter medications because of the lack of regulations and oversight in this "dietary supplement” market space. Regulations can be used to provide a competitive advantage to large companies, who can afford to comply with a complex regulatory landscape. Whereas as smaller companies, who are unable to comply with more complex and costly regulations and oversight are soon driven out of business. This can result in a lack of competition and innovation. In the end, the consumer loses, as it will pay higher prices and be left with fewer choices. In the supplement market, this also means that new products will take much longer to be approved.

CHPA CEO Scott Melville wrote an article, placed in the “Natural Products Insider” <such a hippy-dippy sounding name> titled: “The underappreciated need for DSHEA modernization” where he lays out the reasons needed for a modernization of the Act. Basically, this is a call out for more regulatory control.

It is time for Congress to take up comprehensive legislation to further protect consumers of dietary supplement products while facilitating the continued growth of the responsible sectors of the industry.

Modernization efforts should not be viewed as replacing the DSHEA framework, which provides a sound regulatory framework for the industry, but instead as an update and modernization based on the experience of the past 27 years.  We are not advocating for, nor do we want to see, a change in the balance DSHEA provides in consumer protection and product access. Rather, we are advocating for targeted legislation in select areas that addresses the regulatory and legal gaps of the enforcement framework while providing clear guidance that industry can follow and ensure standards for cGMP and NDI notice requirements are followed by everyone.

The CHPA is lobbying Congress to change the Act to require:

1. Mandatory product listing.

2. Master File New Dietary Ingredient Notification (NDIN) and Innovation Incentives (this is an huge regulatory burden on small companies). In particular, this amendment would require EACH company to submit its own safety data for any new dietary supplement. I believe that this will essentially open the door for the regulation of clinical trials to be conducted on all new dietary supplements.

3. cGMP Inspections: Certifying the Certifiers (“developing a program that certifies third-party inspections done to FDA’s standards”)

4. Third-party Literature in the Digital Age (limiting digital advertising)

5. Definition of Dietary Ingredient (“More robust and precise regulations”). Again, more burden that will stifle innovation.

Taken in sum, these new regulations would cause a large majority of the herbal and dietary supplement companies to go out of business and to stop innovating new products. Which of course, is exactly what the large over-the-counter drug companies desire. Over-the-counter medications are the bread of butter of the industry, and the supplements market is cutting deeply into their market share.

Both the FDA (in 2018 under Scott Gottlieb) and various members of Congress continue to advocate for overhauling the Dietary Supplement Health and Education Act, so consumer pushback is definitely needed now.

Safety:

There is no question that oversight in the supplement industry is needed, and the FDA provides that. When a product is unsafe, adulterated, or mislabeled it is pulled off the market rapidly.

Although there is a lot of chatter about the dangers of herbal and dietary supplements, finding data to support those claims is difficult. There are case reports on caffeine overdoses. The risks of taking blood thinners such as Warfarin while imbibing herbal or dietary supplements is well known, and such blood thinners carry a warning label. One exception is that many do not know that the relatively new product, nattokinase, also acts as a blood thinner and should not be taken with warfarin or other anticoagulants. Likewise, nattokinase should not be consumed by people with a blood clotting disorder.

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Can you trust your physician for advice on supplements?

Many internet sites suggest speaking with your physician before taking supplements. Unfortunately, most physicians will err on the side of caution and will not advise supplement use. Most physicians have almost no training in nutrition. There are very few continuing education programs to teach physicians about herbal and dietary supplements. They honestly don’t know - so rather than recommend something they know nothing about, they just advice their patients to avoid taking herbal and nutritional supplements. In my opinion, this is a cop out. Physicians need to educate themselves. The global dietary supplements market size is estimated to be a $164 billion in 2022, with a high projected growth rate during the following ten years.

If you can find a physician to help guide you, one who knows the supplement landscape, that is a huge benefit. Integrated medicine doctors are often great sources of knowledge, and finding a nutritionist that help guide your decisions is another option. One interesting option that is opening up is to consider both blood work and genetic testing to help determine what supplements might work for you. I believe that the benefits and accuracy of blood-based diagnostics for guiding supplement decisions will only improve with time.

Due to less regulatory control, the supplements industry has innovated many new products, dietary formulations, new delivery systems, new indications and new ingredients. The field of supplementation is expanding rapidly - I believe because the FDA has NOT gotten in the way. Yes, the FDA can and often does step in when a product is proven to be unsafe or adulteration is an issue. Is there risk with less FDA oversight? Frankly, yes. There is a system for reporting adverse events and it is clear that treatment associated adverse events, including death, occasionally happen. But at this point in time, I believe that the benefits vastly out way the risks on less FDA oversight, not more.

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The FDA requires that supplements be labeled with the following:

If a dietary supplement does not have this statement on the bottle, it is in violation of the FDA requirements for labelling.

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Buyer Beware:

It is up to the consumer to ensure that the ingredients they are buying are actually in the jar. This is why third party certification of supplements in important. At the very least, a supplement should be labelled as third party tested but ideally should actually name the company providing the testing. Products should be tested for purity, adulteration and contamination (fungus, molds, metals, etc).

There are two main third party certification companies that most experts recommend. They are NSF and USP.

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The non-profit NSF has two certification programs for supplements. They are “NSF Contents Certified” and “NSF Certified for Sport certification”.

NSF certifies products against NSF/ANSI 173, the only American National Standard that establishes requirements for the ingredients in dietary and nutritional supplements. There are three main components of the NSF dietary supplements certification program:

• Label claim review to certify that what’s on the label is in the bottle

• Toxicology review to certify product formulation (we don’t test for efficacy)

• Contaminant review to ensure the product contains no undeclared ingredients or unacceptable levels of contaminants

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U.S. Pharmacopeia (USP). The non-profit USP sets widely accepted standards for supplements as well as mandatory standards for pharmaceuticals.

USP offers the industry voluntary, independent, third-party verification services for dietary supplement finished products and dietary ingredients. The USP Verified Mark is earned by dietary supplement products that meet the stringent criteria of its Dietary Supplement Verification Program. USP also has a GMP Facility Audit Program for dietary supplement and dietary ingredient manufacturers. The program helps ensure that manufacturers have good quality systems and may also help mitigate regulatory risks by preparing manufacturers for GMP inspection.

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When searching for products on aggregator sites, it is useful to put in the search term NSF or USP, along with the supplement name. That pulls up those products that have been certified.

Whenever possible, if you are a US-based consumer, buy products that are made in the USA.

It is important to do your own research on dosing, length of supplementation and the type of formulation. Consumer websites often give good advice, but in the end - I like to go to pubmed.gov to search for the most recent and relevant information on safety, dosing, side-effects, etc. Taking supplements is not without risk, so do your homework.

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Finally, there are many online sites that sell vitamins, but there are some of the biggest. I don’t recommend one over the other -

Amazon at Amazon

The Vitamin Shoppe at Vitamin Shoppe

Thrive Market at Thrive Market

iHerb at IHerb

eVitamins at Evitamins.com

Walmart at Walmart

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