To say that the supplement industry is flourishing would be an understatement – it’s literally exploding with growth. The estimated number of Americans that currently take dietary supplements is estimated to be around 200 million and this number is set to rise even further.
This massive surge in the recognition of supplements calls for certain control and regulations and that’s where the DSHEA from 1994 comes into play. In this article, we’re going to take a closer look at what this abbreviation really stands for, what are its implications and how it was perceived by the industry. As a premiere private label supplement distributor we feel it is necessary for anyone looking to jump into this industry to familiarize themselves with the rules and regulations. This blog will be speaking about the DSHEA!
SO WHAT EXACTLY IS DSHEA IN THE FIRST PLACE?
It stands for the “Dietary Supplement Health and Education Act” that was carried out back in 1994. The primary goal was to amend the Federal Food, Drug and Cosmetic Act in order to establish particular standards to answer the rising popularity of dietary supplements.
It’s also worth noting that the DSHEA looks on dietary supplements as food, not drugs. It actually makes sense since supplements are meant to be a natural addition to a well-balanced diet, as opposed to pharmaceuticals that treat diseases, various conditions and so on.
And subsequently, supplements were given the following definition by DSHEA: Products (other than tobacco) meant to supplement the diet containing one or more of the following ingredients:
- Herbs (or other botanical extracts)
- Amino acids
- Dietary substances used to supplement one’s diet by increasing the total dietary intake
- A concentrate, metabolite, constituent, extract or a combination of any ingredient mentioned in clauses 1, 2, 3 and 4
However, that’s only the official description of dietary supplements and what substances they can consist of. The very important aspect of safety is entrusted to no other than the FDA (Food and Drug Administration).
In fact, the act clearly points out that DSHEA places the burden of proof on the FDA and it also highlights the requirements for new dietary ingredients. What that means is that from 1994 to nowadays, they have been responsible for regulating and monitoring the safety of the supplement industry.
Needless to say, this act also highlights the requirements for new dietary ingredients and for a very good reason – we’ve seen boatloads of new ingredients, literally flooding the supplement market in recent years.
Does That Mean That Dietary Supplements Are Regulated?
Without a shadow of a doubt. Yet, for some reason, there’s a general myth that supplements remain unregulated and that the consumers somehow gamble with their health by taking dietary supplements.
But do note that not all products are created equal. That’s why you have to make sure that your brand relies only on trusted supplement manufacturers that use ingredients approved by the FDA (like we do).
Now, the FDA utilizes two primary regulatory mechanisms when it comes to dietary supplements:
- Product labeling – every time a brand, company, manufacturer etc. makes a claim related to a supplement, that claim has to be submitted to the FDA within 30 days after its initial use. These claims are only restricted to “general structure-function” and shouldn’t insist that a particular supplement prevents or cures diseases. If these regulations are breached, the FDA has all the power in the world to stop the owner of these claims from advertising them.
- Good manufacturing practices – courtesy of DSHEA, these are basically industry standards for sustaining a certain quality of the products. As a result, the FDA controls (through the DSHEA) manufacturers as they are virtually bound to these GMPs.
Supplement advertising though is monitored by the Federal Trade Commission. They require from manufacturers to be perfectly honest about what their supplements contain, as well as solid proof to back any claims they might make.
Last but not least, there’s something called DSNDCPA (Dietary Supplement and Nonprescription Drug Consumer Protection Act) from 2006 and it’s FDA’s main method for informing the public about any incidents associated with a supplement after it hits the market.
DSHEA UPDATES AND NEW RULES
Right at the start of the millennium, the FDA issued an update of the existing rules. These updated rules state that supplement companies are prohibited from making specific claims:
- Express disease claims (like “halts osteoporosis” etc.)
- Implied disease claims (like “prevents bone fragility in post-menopausal ladies)
- Claims made through the name of the product
- Health-maintenance claims (like “maintains a healthy reproductive system”)
- Other non-disease claims (like “this pill will help you relax” etc.)
To put it in layman’s terms, without FDA’s final verdict, supplements cannot carry claims that they treat, cure, prevent, diagnose or mitigate diseases. Generally, serious conditions are as treated as diseases, such as:
Another subject that supplement companies have to be careful with is pregnancy. Any claims about symptoms related to pregnancy are a big no-no in FDA’s eyes, so it’s safe to say that pregnancy can be put in the same aforementioned (serious conditions) category.
CONTROVERSY, DEBATE, CONFLICT AND NEGATIVISM
No matter what angle you look at it, DSHEA still has an awful lot of enemies and many people demonize it. Most of the criticism is geared towards the fact that the FDA doesn’t have the authority to approve supplements before they are marketed to potential consumers.
And we shouldn’t forget the very popular warning message on most (if not all) supplements these days: ” These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
DSEAH’s opposition claims that by using such “warning templates”, supplement manufacturers can get away with any clinical claims. And they also imply that it’s entirely up to the manufacturer to verify these claims, which is rather controversial on its own.
On top of that, conspiracy theorists also state that FDA doesn’t have nearly enough resources to effectively deal with the amount of decent in the supplement industry.
DSHEA’S SUCCESS SPEAKS FOR ITSELF
Nonetheless, all the controversy and negativism towards DSHEA is just fruitless accusations for the most part. It’s been actively helping with the regulatory processes in the supplement market for more than 20 years already.
Without any major amendments as part of its integrity and a relatively small number of issues during that time, DSHEA has managed to achieve a lot, not only in the realm of supplements but in promoting public health as well. And FDA is the key to the success of this act.
According to official data by the FDA, even with some restrictions, they managed to produce outstanding results. This is part of their achievements from the past few years:
- Close to 90,000 bottles of supplements labeled as having kratom in them were seized in 2016. Kratom has been shown to possess narcotic and stimulant-like effects
- They found products containing BMPEA, DMBA and Picamilon and these were illegally marketed. Subsequently, they sent warning letters to 24 companies that marketed supplements with these ingredients
- In 2016, they conducted more than 600 inspections of supplement companies, not only in USA, but in other countries as well. They also cooperated with companies on voluntary compliance actions – removing illegal claims, ceasing distribution etc.
- That same year, pure-powdered caffeine products led to the deaths of two teens. FDA issued warning letters to 5 distributors of these potentially harmful products, in an attempt to prevent further incidents
- The FDA works closely with the Department of Justine, the Federal Trade Commission and the US Postal Inspection Service in order to find potentially harmful products and ones that contain ingredients that are not listed
- Back in 2015, civil injunctions and criminal actions were taken against 117 supplement manufacturers and distributors
It’s intriguing to see that the FDA actually intends to expand the use of criminal investigation and enforcement tools so that they can tackle fraudulent activities and violations related to the safety of the products. Also helping educate consumers on the differences between supplements and drugs.
That’s supposedly an effective method for dealing with shady manufacturers and companies that throw wild and unrealistic claims. And lastly, companies that sell products that can be potentially harmful to anyone taking them.
The FDA deserves praise for their desire to safeguard the consumers from supplements and ingredients that can be detrimental to their health. After all, the consumers have the right to expect quality and above all – safety.
WHAT DOES THIS MEAN FOR YOUR BRAND?
Your supplement brand’s success lies in the quality of your products and especially the manufacturer that supplies you with them. For this reason, always make sure to focus on companies that are compliant with the FDA guidelines.
StockNutra is such company and we are proud to offer:
- The highest quality private label supplements
- GMP certificates
- FDA labeling competence and guidance
- Dietary Supplement Health and Education Act Of 1994
Public Law 103-417
103RD Congress – https://ods.od.nih.gov/About/DSHEA_Wording.aspx#sec2
- Making Progress in Protecting Consumers from Unsafe Supplements – https://blogs.fda.gov/fdavoice/index.php/tag/dietary-supplement-health-and-education-act-dshea/