Understanding the wild west of supplements
What is Ashwagandha, and should you take it? Please note the typo when discussing DNI's as the slide shows DRI's, which is incorrect
NAC, do you need it?
The Who, How, and What’s
of the
US Dietary Supplement Industry
WHO is involved in the supplement industry, and WHAT do they do?
Dietary supplements are regulated in the US through two federal agencies: the Food and Drug Administration and the Federal Trade Commission.
The Food and Drug Administration (FDA) broadly oversees supplement safety but does not regulate efficacy. This agency is responsible for removing products from the shelves AFTER adverse symptoms have been shown from ingesting the supplement. (Raymond et al., 2022). Only two supplements have fallen into that category to date: Ephedra and DMAA due to cardiac toxicity resulting in death (Raymond et al., 2022). The removal process took years and was very costly (Price 2015).
The FDA conducts over 600 random searches of supplement manufacturing companies annually and has sent over 900 warning letters to manufacturers (Natural Products Association, 2018). The most frequent offense is failure to test for the supplement's identity, potency, and purity (Raymond et al., 2022).
The Federal Trade Commission (FTC) monitors supplement companies’ labels, claims, and advertisements to ensure manufacturers market their products correctly (Raymond et al., 2022).
HOW dietary supplements are regulated.
In 1994, after decades of vitamins and supplements bouncing between the food and drug sectors, the Dietary Supplement Health and Regulation Act, or DSHEA for short, was created (Raymond et al., 2022). Regulations for supplements would now progress through them.
DSHEA clearly and definitively placed vitamins and supplements into their own category, aligning with the food group rather than the food additive group or the drug sector (Raymond). This allowed people the luxury of choosing what dietary supplements they thought were best and gave the supplement industry far more freedom than if they had been placed into the drug category or dietary additive sector.
Under DSHEA, supplement manufacturers were made responsible for the safety and proper labeling of dietary supplements and must meet government requirements before putting supplements on the shelves (Raymond et al., 2022).
WHAT type of claims can be made on supplements?
There are three categories of supplement claims currently allowed on bottles per DSHEA.
Structure/Function claims are meant to describe what the supplement may be helping with but do not allow for specific claims. For example, the dietary label can claim that the supplement supports heart health; however, claims such as “will prevent heart attacks and strokes” are not permitted on the label (Raymond et al., 2022).
These claims do not have to be approved before hitting the market but must be sent to the FDA within 30 days of being on product shelves. The claims also must be accompanied by the statement; *“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.” (Price 2015).
Health claims—Supplement labeling can mention specific disease states as long as there is legitimate scientific backing of 2 randomized clinical trials (Natural Products Association, 2018). An example would be, “A high-fiber diet has been shown to lower your chances of cardiovascular disease when accompanied by a diet low in saturated fat.” The FDA must approve these claims. Under no circumstances can a product claim to cure a disease (Raymond et al., 2022).
Nutrient claims—Here, you can find specific lists of the ingredients and their amounts in the product you take per dosage listed on the supplement label (Raymond et al., 2022). DSHEA has broadened the list of ingredients to include botanicals, enzymes, herbs, etc. (Price, 2015). Other examples of nutrient claims are “40% of omega-3 fatty acids”. Manufacturers must list everything in the supplement except proprietary blends, which do not have to be disclosed (US Food and Drug Administration, 2022). Frankly, that seems to be a loophole for companies to get around listing what is in their product.
HOW do supplement regulations differ from drug regulations?
To pass a drug onto the general population, it must go through a regimented process.
First, there are in vitro studies to determine if the drug is toxic (Price, 2015).
Second, the drug moves on to animal trials using at least two different animal species. The animal trials show if the drug interacts with the body correctly or if it metabolizes into other dangerous substances internally. They will also show if the metabolized drug gets excreted via waste or sticks around to do the intended job in the body. The drug's after-effects are also studied during this phase. Did the animals change in personality, lose weight, gain weight, or have altered sleep habits (Price, 2015)?
Third, the drug then moves on to the three stages of human trials, each stage progressing in the
number of volunteers to prove safety and efficacy (Price).
After the drug reaches the market, it must contain an in-depth insert for the patient that describes possible side effects and detailed information on how the drug works. The FDA requires companies to report all adverse events and inspect all drug manufacturing facilities. 95% of all experimental drugs do not meet FDA’s standards and fail to make it to the market. Companies can spend upwards of 5.2 billion dollars just attempting to bring one drug to the market (Price 2015).
You may have guessed by now that the same regimented requirements do not apply to the supplement market.
When DSHEA was passed in 1994, it grandfathered in all the supplements already on the market. These products fall under Generally Recognized as Safe, commonly called GRAS. This means that all products before 1994 that had not been researched were deemed “safe” until proven otherwise by the general population’s reactions to them (Price 2015).
New dietary ingredients must be sent to the FDA with a statement from the manufacturer explaining why they should be considered safe 75 days before going to market. The manufacturers do not have to study what the supplements affect when people consume them, nor do they have to research long-term effects or drug interactions (Price, 2015) They do however need to provide scientific studies, historical consumption, and how the body metabolizes the new ingredient.
*** They also are required to include
The name of the new dietary ingredient. If the new dietary ingredient is an herb or other botanical, you must include the Latin binomial name (including the author).
A description of the dietary supplement or dietary supplements that contain the new dietary ingredient, including the:
level of the new dietary ingredient in the product;
conditions of use of the product stated in the labeling or if no conditions of use are stated, the ordinary conditions of use; and
history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will be reasonably be expected to be safe.
Any reference to published materials must be accompanied by reprints or photostatic copies.
Any material in a foreign language must be accompanied by an English translation.
(www.fda.gov)
In 2010, Good Manufacturing Practices (GMPS) were implemented in the supplement industry. This required that manufacturers submit to the FDA paperwork proving that their products contain the ingredients they claimed they did (Price 2015). GMPs also oversee the construction of the manufacturing plant and conduct random audits to review cleanliness, quality, and control procedures, maintain records, and review consumer complaints (Raymond et al., 2022).
The 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act required manufacturers to report serious adverse effects to the FDA. This does provide a level of protection for consumers, but it should also be understood that a “serious adverse event” is defined as a life-threatening illness. Many other serious illnesses are not reported to the FDA (Price 2015).
The ease at which supplements can enter the market due to DSHEA is very clear when reviewing the number of supplements that have entered the market. Before DSHEA, there were 4,000 supplements; today, there are well over 85,000 (Price 2015).
The differences between drug and supplement regulations raise the question of whether we should make changes to regulate supplements more strictly.
While most people can take supplements safely, there are cases where supplements have caused damage (Price 2015). If supplement stores are mandated to have a sign displaying how little the FDA is involved in the supplements industry, it may give people pause before purchasing supplements and cause them to do a little more research into what they are taking and different interactions that may come from the supplements. The statement “*The statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” sounds more like the FDA does not want to be sued rather than educating the public on how little the FDA is involved in regulating the supplement industry.”
The freedom to choose what supplements a person would like to take should remain the same. What needs to change is the education of the public, and I feel that it should be covered at the government's expense, not the supplement industry. Conversely, if severe adverse side effects can occur from taking specific supplements, that should be listed on the box or bottle. For example, the Red Yeast Rice supplements should expressly state,” This product has been known to cause harm to unborn babies.” Supplement manufacturers should also be required to list the levels of the active ingredient responsible for the supplement's effects. For example, Red Yeast Rice products should be required to list the levels of effective ingredients in the bottle, Monacolin K. If these changes occur, I believe the supplement industry may be slightly safer for the population!
References
Natural Products Association (2018). History of Dietary Supplement RegulationLinks to an external site.. [Video]. YouTube. URL: https://www.youtube.com/watch?v=kLzOjCzmNCk
Price, Catherine. (2015). Vitamania: How Vitamins Revolutionized the Way We Think About Food (p. 160). Penguin Publishing Group. Kindle Edition. (Vitaminia).
Raymond, J.L. & Morrow, K. (Eds.). (2022). Krause and Mahan’s Food and the Nutrition Care Process (16th ed). Elsevier.
U.S. Food and Drug Administration. (2022). Questions and Answers on Dietary SupplementsLinks to an external site.. URL: https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements
