Dietary Supplements

No Approval Necessary

From a legal standpoint, there is a third class of food chemicals in the United States that are neither food additives nor contaminants.  Like food additives, these chemicals have an intentional use; when consumers buy them, they expect or hope that it will have some desirable consequence.   Yet, unlike food additives, they do not require FDA approval before they can be sold.  This is pretty much true by definition: If a manufacturer wants to get FDA approval, they can.  But if they decide that is too difficult or not possible, they can call it a Dietary Supplement and sell it anyway.

There are some restrictions.  If a manufacturers are going to sell a new supplement, they are supposed to notify the FDA and send in whatever information they have about the supplement.  The FDA may decide to object to the sale, or not.  In particular, dietary supplements are subject to the same legal standard as unintentional contaminants, so if the product is hazardous enough to meet the “may render injurious” standard, then the FDA can prevent sale of the product. 

Yet outside the commonality of “no FDA Approval”, the range of products that are sold as dietary supplements is tremendous, as are the reasons for NOT seeking FDA approval.  Some may be sold as supplements because the process for getting approval is too expensive for small companies, which is probably the most legitimate reason.  Some may be sold as supplements because they couldn’t meet the rather strict safety standards required for food additives.  The supplement route can also be used to avoid the approval process required for drugs.   And finally, products that really have no use at all can rather easily be sold as dietary supplements.

Nutritional Supplements

If a product is sold as a dietary supplement, nutrition is what most people have in mind.  There are nutrients like calcium, iron, and vitamins that some people don’t get enough of in their diet, and therefore they need supplements to meet their nutritional requirements.  So, supplement manufacturers put nutrients in pills, and sell then to consumers that may need them. Furthermore, the amount of a particular nutrient in a supplement generally follows recommendations made by the Federal government.  Since nutrients can also be toxic, dietary guidelines consider both how the amount of the nutrient is that is necessary and how much may be excessive  (Institute of Medicine, 2013).  That all sounds good, and it is. 

However, that doesn’t mean supplement purveyors won’t encourage consumers to buy supplements they don’t really need.  Free enterprise, yay.  For example, you can buy a manganese supplement.  Yes, manganese is an essential nutrient – that has been demonstrated in animal studies with controlled artificial diets.  However, there is no evidence that anyone has ever suffered from manganese deficiency.  On the other hand, there is evidence from human studies that indicate that manganese is neurotoxic with symptoms that closely resemble Parkinson’s disease.

Drugs

Many of the substances sold as dietary supplements are really drugs.  While nutrients are essential to normal structure and function, drugs are not.  Before the Dietary Supplement Health and Education Act of 1994, selling a drug as a supplement was illegal, but now it is not.   Like the drugs that are regulated by the FDA as drugs, the drugs sold as dietary supplements have a wide range of effects.  Many of them can be used to treat various diseases.  There are also many psychoactive substances sold as supplements that alter mood or behavioral performance.  The best known example is caffeine, which is also used as a food additive.

Perhaps the best example of the drug subcategory of dietary supplements is ephedra, a plant that contains ephedrine.   Ephedrine is a sympathomimetic compound that has many of the same pharmacological properties as adrenaline and other substances that occur naturally in the human body.  It is also very similar to many of the drugs (e.g. pseudoephedrine or Sudafed) found in over-the-counter cold medicines that can be obtained in the U.S. and elsewhere without a prescription.  In China, the herb is known as Ma Huang, which like many other products sold as supplements, has a long history of use in Chinese medicine.  It can indeed be a useful treatment for colds.  Ephedra has also been marketed as a stimulant (i.e. in “energy” supplements) and for weight loss.   It works for that too.  But, like many other drugs, it can have side effects, and an overdose can be lethal.  In fact, many people have died from ephedra overdoses.   As a result, and because the FDA can regulate supplements when there is demonstrable harm, ephedra has been banned.  However, you can still grow ephedra yourself, or order synthetic ephedrine from Canada and have it delivered to the United States.

The drugs sold as dietary supplements may or may not be better than drugs approved by the FDA as drugs.  Leaving that issue aside, there is another problem:  Products that are sold as natural remedies in other countries are sold as dietary supplements in the United States, which one might expect to lead some people to think of those products as foods, rather than medicine.  Since people don’t expect to OD on food, they are more likely to do so with a dietary supplement like ephedra.  That’s a problem.

Placebos

The third category of dietary supplements are comprised of substances that pretty much don’t do a damn thing.  You can put dirt in a capsule and sell it as a dietary supplement, and guess what, people do.  Giving people the hope of a cure can, in fact, be a cure; so maybe they are worth something.  A good exemplar here is Laetrile, otherwise known as amygdalin, which is found in bitter almonds, apricot pits, and cassava.  It is called a cyanogenic glycoside because it releases cyanide when ingested.   Even though there is no scientific evidence to support claims that laetrile or amygdalin can treat cancer or any other illness, it has been marketed and used as an anticancer agent.  It was especially prominent in the US during the 1970’s, when it came to called “Vitamin B17” even though it isn’t a vitamin at all.   Although the evidence of harm at recommended levels of use isn’t especially strong, the cyanogenic properties of amygdalin led to an FDA ban in 1971.

The biggest downside of placebos is that they may be used instead of a treatment that would work.  Nonetheless, the main thing the FDA does with regard to placebos is to regulate health claims; a supplement manufacturer cannot claim on the label or packaging that a supplement will produce a desirable health effect without getting FDA approval first.  However, supplement manufacturers can put whatever claim they want on the internet, and they do.  For example, they will tell you that Laetrile works: Google it for yourself.

Reference

Institute of Medicine (2013).  Dietary Reference Intakes Tables and Application.  National Academy of Science, Washington DC.

Official Post Soundtrack

Pere Ubu (1977).  Final Solution.  In: Terminal Tower, Track 3.

Post Note

Thesis Post #50.  Part of the Regulatory Toxicology series.