Part I: Who’s in Charge Here?
Dietary supplements. Chances are, once or twice in your lifetime, you’ve walked through a medical supply aisle at your local drug store and thought to yourself, “Maybe I should be taking these vitamins,” or, “Perhaps I do need more fish oil in my diet.” Luckily for you, market shelves in the United States are bursting with options for each and every American who, just like you, thinks the nutrients they are receiving from food might be lacking.
Personally, I enjoy the gummy versions of supplements: bright colors and sugar crystal coating looks like a good option to get some extra nutrients! It’s rare that we really question who approved this gummy bear vitamin, or even more importantly, whether it actually contains what it says it does. This two-part blog series will explain 1)The evolution and process of supplement regulation in the United States and 2) What’s actually in those supplements you’re grabbing off the shelves to supplement your nutrient-deficient diets.
The supplement market is gigantic. In the United States, people are always looking for easy ways to eat a healthy diet. Rather than taking time to cook a nutritious meal, it is easier and more convenient to pop a couple of capsules and call it good. In 2012, the United States dietary supplement market earned over 11 billion dollars, at a growth rate of nearly 7% per year. A supplement is defined by the FDA as a product that is intended to supplement the diet; contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents; is intended to be taken by mouth as a pill, capsule, powder, softgel, gelcap, tablet or liquid; and is labeled on the front panel as a dietary supplement.
In the Early 1990s, Congress set out to strengthen the ability of government agencies to stop health frauds. Congress considered two separate bills to combat this issue. The first bill would amend the Food Drug and Cosmetic Act (FDCA) to increase the ability of agencies to issue a recall of food, drug, device or cosmetic which was in violation of the FDCA or presented a significant risk to human or animal health. The bill would grant this authority to the Secretary of Health and Human Services.
The second bill that Congress considered was the Nutrition and Drug Coordination Act of 1991, which would have amended the Federal Trade Commission Act to impose stricter prohibitions against misleading advertisements, and accordingly would have made it illegal to advertise any nutritional or therapeutic relationship to a food product unless it was in accordance with specifications of the Food Drug and Cosmetic Act.
Despite the efforts to pass these bills, neither was passed because of an industry uproar protesting further hurdles to jump to get food on the market shelves, leading to a public outcry for less government involvement in food regulation. The health food industry, like the meat industry that opposed further labeling and inspection of their meat in the early 20th century, hurriedly approached Congress, lobbying that these regulations would take away consumer freedom to choose dietary supplements for their “health.” With the help of retailers and manufacturers alike, the public joined the brigade in concern these regulations would ultimately hinder their freedom of choice; how un-American!
This ultimately led to the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under DSHEA, manufacturers need not seek or receive any approval from the FDA before marketing dietary supplements. Notably, the DSHEA defines a supplement as a food instead of a drug, and more specifically, a dietary supplement is:
“[A] product (other than tobacco) intended to supplement the diet that bears or contains one of more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient noted in clause (A), (B), (C), (D), or (E).”
Because supplements are now categorized as food instead of drug, the criteria for approval lessened substantially, and practically speaking, were almost eliminated entirely. A supplement now could be sold and marketed to the public with limited government interference, and without any approval before hitting the shelves.
With this in mind, manufacturers of food are prohibited from marketing and selling foods only if they are adulterated or misbranded. The manufacturers are responsible for ensuring their product is unadulterated and has is branded and advertised accurately; the supplement is not tested or evaluated prior to its appearance on market shelves to ensure that it complies with the label its bears nor that it is not polluted with an adulterant. The FDA only intervenes in this respect after a complaint has been received. That is, there will be no intervention until some damage has already done: a reactive, rather than proactive form of regulation.
In order to avoid adulterants in supplements, the DSHEA includes a section about new dietary ingredients, which deems any “new dietary ingredient” an adulterant. A new dietary ingredient is defined only as any ingredient that was not marketed in the United States before October 15, 1994. The purpose of this section was to avoid the introduction of any potentially dangerous new ingredients in supplements. Enforcement of this section of DSHEA has been confusing and difficult, but no official guidance has been released, despite numerous requests.
The only federally required label on a supplement, according to the FDA is as follows:
FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a ‘supplement;’ the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product. In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a ‘Supplement Fact’ panel. This label must identify each dietary ingredient contained in the product.”
A “descriptive name of the product stating that it is a supplement” leaves an overwhelming amount of room for a creative marketing team to label a bottle of capsules as a life-changing miracle pill, all while staying within the minimal regulations of the FDA. Under FDA regulations, supplement labels may not make medical claims, because this is reserved for drugs; however, as I’m sure you’ve all seen, creative marketing teams have found an easy way around this.
DSHEA requires that a dietary supplement label may include a claim explaining the role of a dietary ingredient or nutrient intended to affect a structure of the body, so long as it states in a “disclaimer” that the FDA has not evaluated the claim. We’ve all seen it; we’ve picked up a bottle of vitamins, excitedly proclaiming; “Immune System Support*,” and then in fine print on the bottom: “*This statement has not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Essentially, the main label can make any claim it wishes, so long as it provides this disclaimer, usually hidden at the bottom or on the back of the label. In 2000, the FDA revised a final rule on health claims to combat the instances of false advertising. DSHEA still prohibits any disease-related claims, such as “Helps cure the flu,” however, it allows health-maintenance claims, and non-disease related claims, for example, a “bedtime” tea that “Helps promote restful sleep.”
The FDA maintains that the manufacturer is responsible for ensuring the accuracy of the claims on their label, but by limiting their claims to maintenance claims such as: “promotes eye health,” or “immune system support,” it is difficult for a consumer to actually prove the statements as false. There is no law or regulation that requires manufacturers to disclose any information they have regarding the statements they are making about their products, nor any safety information. DSHEA places great responsibility on consumers to think for themselves and evaluate the claims made on these labels using their own knowledge. The FDA boasts that manufacturers are required to list each and every ingredient contained in the product; however, with little to no official testing done on these supplements to guarantee that they contain what they say they do, there is little motivation for manufacturers to be completely honest in their disclosure, but we’ll get to that in Part 2.
Through avoidance of a heavily regulated nutrient supplement industry, consumers have created an industry where companies can release a supplement claiming to “promote heart health,” so long as they accompany it with a disclaimer at the bottom of the label. This product may or may not contain ingredients that are beneficial to your heart, and although the manufacturer is required to list all of the ingredients and the net contents, the FDA does not test supplements for accuracy. As a consumer, you are putting a great amount of trust into the manufacturer to give you a capsule or gummy vitamin containing what the back panel says it contains; or you could just make a salad and get your vitamins and minerals directly from the source – it’s all about who you trust.