- Although the FDA technically regulates the dietary supplement industry, there are many issues in this niche that could be dangerous for the unlucky customer.
- There are no strict requirements for supplement safety and efficacy.
- Many dietary supplements contain ingredients not mentioned on the product’s label, and many brands do not report about new components in their products to the FDA (even though they’re legally supposed to).
- The real concentration of any given ingredient in any given dose can range from 9% to 146% of the stated dose on the label.
Health supplements in the US: not so healthy as they seem?
Millions of Americans take dietary supplements to support or improve their health, but many of these products are ineffective and spout false claims. Moreover, some of them can be downright dangerous when taken without professional supervision.
The multi-billion dollar industry of dietary supplements is supposed to be regulated by the Food and Drug Administration (FDA), but this regulation is ineffective at best.
What are the main dangers you should be aware of? Let’s look into the details.
What is this study about?
Published in 2015 in the American Journal of Public Health, this research is a detailed overview of the most significant regulatory and safety issues in the dietary supplement industry at the moment.
On doses, ingredients, and safety
One of the most significant concerns related to the production, marketing, and usage of dietary supplements is their safety and potential efficacy. According to the current regulations:
- Supplements don’t have to be extensively tested for efficacy.
- Limited data on safety is usually enough for a supplement to be sold freely.
- Products can contain any dose of any ingredient if the label explicitly mentions the daily recommended value for the said ingredient. For instance, some supplements contain 50 000 IUD of vitamin D. To the FDA, that seems to be alright because the label states that each dose contains 12 500% of the recommended daily value. But is it?
- If the daily recommended value hasn’t been established by the FDA, supplements can be produced and marketed without this data.
- There are no recommendations or restrictions as to what combinations of ingredients supplements can contain.
- Many brands do not inform the FDA of changes in the ingredients of their products. Technically, companies can sell supplements with potentially dangerous new ingredients until the court rules in favor of the FDA and demands the suspension of these products.
The ingredient X
Despite the Current Good Manufacturing Practice (cGMP) guidelines issued by the FDA in 2007, many manufacturers still fail to prevent contaminants from getting into their supplements.
- In 2010, the US Government Accountability Office reported that 93% of the tested dietary supplements contained trace amounts of at least one major contaminant: arsenic, lead, mercury, cadmium, or pesticides. All are extremely dangerous for human health.
- It’s estimated that 59% of botanical dietary supplements contain plants that aren’t mentioned on the ingredients label. Also, 83% of these manufacturers tended to switch the active ingredients in their formulas for similar ones.
- Even when all ingredients are present as reported, their concentration in each dose may vary significantly. Studies reported it could be anywhere from 9% to 146% of the concentration stated on the label.
Dancing around the health claims
Dietary supplement manufacturers are forbidden to market their products as such that may treat or prevent particular diseases—in other words, disease claims are banned.
However, general health claims are good to go, as well as nutrient content claims and function claims. Having a bit of scientific data on any of these matters is usually enough for the FDA—especially if the label states that these claims haven’t been evaluated by the FDA.
In other words, a supplement can’t be marketed as one that treats coronary disease, but the product can state that it ”supports heart function” or ”improves blood circulation in the heart.” As long as the product keeps an eye on its statements and doesn’t forget to include an FDA disclaimer somewhere on its label, it will likely be deemed safe and legal.
The FDA regulates the health supplements industry in the United States under the Dietary Supplement Health and Education Act of 1994 (DSHEA). At the moment, however, this regulation is far from effective.
To summarize, although the possibility of taking ”all-natural” supplements to support your health sounds like a good deal, they may do more harm than good if you’re unlucky enough to pick a low-quality product.
As always, the best approach is to follow the REAL all-natural path:
- A healthy and well-balanced diet
- Regular physical activity
- A healthy sleep routine
Link to the study: