By: Fatema Elias, Staff Writer

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With the New Year and everyone committing to their New Year resolutions, more and more patients are coming into the pharmacy asking for recommendations, particularly for weight loss dietary supplements. I hesitate to recommend an over-the-counter dietary supplement for weight loss. However, we as pharmacists and pharmacy students have to realize that patients come to us for advice, and if we tell them that we cannot recommend anything, we should at least give them some guidance. We cannot simply turn them away by saying that there aren’t products to use, because we may be leading them to other options that can be harmful.

The other day, a patient came into the pharmacy asking me to help her find a particular dietary supplement. Even after I explained that most dietary supplements have ingredients that do not show advantageous results and that some products have unknown mechanisms of action, the patient was undeterred, and ended up purchasing the ‘Acai Berry 14-day Fat Burn Cleanse’ product.

This brings to light an underlying issue. Patients are getting their healthcare information often from unprofessional and unreliable sources. Even with the risk of unknown side effects, patients are jumping into taking new supplements just to ‘test it out.’ Although the Food and Drug Administration (FDA) has identified dietary supplements that contain ingredients that could be harmful to users, it cannot test all supplements on the market that can contain potentially harmful ingredients. Still there are enforcement actions by the FDA and consumer advisories for products that are tainted which cover a fraction of the products that may potentially harm the buyer.¹

In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law.² Previously, dietary supplements were subject to the same regulatory requirements as other foods were. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created new regulations for the safety and labeling of dietary supplements. Currently, manufacturers of dietary supplements determine whether the products they distribute are safe for the public, unlike the FDA approval process that drugs go though. However, when a manufacturer wants to market something that is known as a ‘new dietary ingredient,’ it requires a pre-market review for safety data.^{3, 4}

A ‘dietary ingredient’ and a ‘new dietary ingredient’ are components of dietary supplements. In order for an ingredient of a dietary supplement to be a ‘dietary ingredient,’ it must be one or any combination of the following substances: 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 (e.g., enzymes or tissues from organs or glands), or a concentrate, metabolite, constituent or extract.² A ‘new dietary ingredient’ is one that meets the above definition for a ‘dietary ingredient’ and was not sold in the U.S. in a dietary supplement before October 15, 1994.² The FDA published comprehensive regulations for current good manufacturing practices for those who manufacture, package, or hold dietary supplements. These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.

Once a product is on the market, retailers and distributors must take responsibility for abiding by the FDA’s regulations. The FDA publishes a list of products marketed as dietary supplements with hidden drugs and chemicals.⁴ Some of the recent ones were promoted for weight loss, but have been found in lab analysis to have tainted dietary supplements along with other approved prescription drug ingredients and their analogues that are potentially dangerous. For example, ‘MAXILOSS Weight Advanced’, ‘Dream Body Slimming Capsule’ and ‘Celerite Slimming Capsule’ contained the hidden chemical sibutramine, and ‘Magic Slim’ contained the hidden chemicals sibutramine and phenolphthalein.⁵ Sibutramine has been associated with increased cardiovascular events and strokes, and the products were consequently removed from market and banned by FDA.⁵

Companies that sell dietary supplements play an important role in preventing tainted products from reaching consumers. Manufacturers have the legal responsibility to ensure that their products are not mislabeled and that their advertising does not misinform consumers. Anyone who sells or distributes products that do not follow these guidelines is “subject to criminal liability—misdemeanors and felonies, seizure of products, injunction of the responsible party/company, and disgorgement of profits and restitution.”⁶ In the past decade, the FDA has become increasingly active in pursuing criminal convictions for companies selling tainted supplements.⁶

There are some things that we as consumers, pharmacists, and pharmacy students can do to help the FDA better regulate dietary supplements. In order to keep safe supplements available on the market and to keep potentially dangerous ones away, the FDA relies on the voluntary reporting of adverse events. Reports can be made even if you are unsure of whether it was the product alone that caused the problem. FDA uses the data to maintain safety surveillance of FDA-regulated dietary supplements.⁷

So should you stop taking your daily diet pills? Not necessarily. Be cognizant of what you are buying and be wary of adverse effects. Ask yourself “is it too good to be true?” Some things to look out for when searching the web for dietary supplements is to check who operates the site, what the purpose of the site is, what the source of the information is, if there are reliable references, if the information is current, and if the email solicitations they send are reliable. Think twice about chasing the latest headline, check your assumptions, and contact the manufacturer for more information about the product you are purchasing if you have any doubts. Also, be open to reporting any side effects that may be related to supplement use without hesitation. This can help you protect yourself and also protect consumers everywhere just like you.

Definition of New Dietary Ingredient (NDI), Requirement for NDI Notification and Applicability of NDI Adulteration Standard4
	New Dietary Ingredient (NDI)	NDI notification required?	NDI adulteration standardapplies?
A dietary ingredient that was marketed in the U.S. before October 15, 1994	No	No	No
A dietary ingredient that was NOT marketed in the U.S. before October 15, 1994 AND was present in the food supply as an article used for food which has	Yes	See a) or b)	Yes
a) not been chemically altered	Yes	No	Yes
b) been chemically altered	Yes	Yes	Yes
A dietary ingredient that was NOT marketed in the U.S. before October 15, 1994 AND was NOT present in the food supply as an article used for food.	Yes	Yes	Yes

SOURCES:

1. Food and Drug Administration. Medication Health Fraud-Tainted Weight Loss Products. U.S. Food and Drug Administration. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234592.htm. Updated November 30, 2010. Accessed January 08, 2014.
2. Food and Drug Administration. What is FDA’s roles in regulating dietary supplements versus the manufacturer’s responsibility for marketing them? U.S. Food and Drug Administration. http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/default.htm#FDA_role.Updated November 30, 2009. Accessed January 22, 2014.
3. Food and Drug Administration. Dietary Supplements – New Dietary Ingredients in Dietary Supplements – background for Industry. U.S. Food and Drug Administration. http://www.fda.gov/food/dietarysupplements/ucm109764.htm#what_info. Updated March 16, 2009. Accessed January 28, 2014.
4. Food and Drug Administration. Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient. U.S. Food and Drug Administration. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm257563.htm. Published July 01, 2011. Updated August 19, 2013. Accessed January 08, 2014.
5. Food and Drug Administration. Tainted_Supplements_CDER. U.S. Food and Drug Administration.  http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder. Updated January 08, 2014. Accessed January 08, 2014.
6. Food and Drug Administration. Tainted Dietary Supplements and Foods: Responsibilities of Retailers and Distributors. U.S. Food and Drug Administration. http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/UCM230993.pdf. Updated October 2010. Accessed January 08, 2014.
7. Food and Drug Administration. Reporting Serious Problems to FDA – OTC Products and Dietary Supplements. U.S. Food and Drug Administration. http://www.fda.gov/Safety/MedWatch/HowToReport/ucm085680.htm. Updated February 02, 2013. Accessed January 08, 2014.

Published by Rho Chi Post