Recently, NPTA did an article on the Consumer Reports piece on the 12 “Dirty Dozen” ingredients found in dietary supplements that have been linked to health problems. Several readers of the article posted some great questions about dosing information, what kinds of dietary supplements these ingredients are found in and what should people be doing to use dietary supplements safely. The Consumer Reports piece is just the latest in a slew of controversy surrounding dietary supplements, how they are regulated and how they are marketed.
To shed some light on the situation regarding dietary supplements and to help pharmacy technicians provide consumers with more information on dietary supplements, we reached out to the Council for Responsible Nutrition, one of the dietary supplement industry’s most prominent trade associations. Dr. Douglas MacKay, N.D., the CRN vice president of scientific and regulatory affairs, graciously took time to explain exactly how dietary supplements are regulated, some of the most common illegal marketing practices concerning dietary supplements, and what consumers and health care professionals can do to protect themselves from unsafe and illegal dietary supplements.
For consumers who are worried about the dietary supplements mentioned in Consumer Reports, what’s the best thing they can do to make sure the ingredients in their supplements are safe and legitimate?
The best thing that consumers can do is check the label, MacKay said. If they have any questions about dosages or percentages of the ingredients found in their dietary supplements, consumers should visit the website of the supplement’s manufacturer, or they should speak with their pharmacist or primary care physician. CRN also has a label breakdown page that pharmacy technicians can use if they are approached by consumers with questions about a dietary supplement’s label and its ingredients.
Does the FDA consider dietary supplements a food, a drug, or do they have their own special category?
Dietary supplements are considered a food by the FDA, but they fall under a special category of food per the Dietary Supplement Health and Education Act (DSHEA) of 1994. Some dietary supplements can be marketed as both a supplement and a drug. As long as the manufacturer applies for pre-market approval as a drug with the FDA, the supplement can be marketed for medical purposes. A good example of this is calcium carbonate. In addition to being sold as an inexpensive calcium supplement, calcium carbonate is marketed as an OTC antacid medication by companies such as Bayer (Alka-Mints), Johnson & Johnson (Rolaids Calcium Rich) and GlaxoSmithKline (Tums). If a product is being marketed and sold as a supplement and a drug, it should have dual labels with a Supplement Facts box and a Drug Facts box. Another good example of this is omega-3 fatty acids. There is a drug Lovaza, which is FDA-approved as a prescription drug for high triglycerides. The company, GSK, can market for this indication. This product will also have a Drug Facts box. Only fish oil can make FDA–approved qualified health claims for omega-3 fats or structure function claims in marketing and has a Supplement Fact box.
How are dietary supplements regulated by the FDA?
Since dietary supplements are considered foods, they are regulated much the same way foods are. Therefore, there is no pre-market approval process by the FDA for dietary supplements. However, DSHEA did establish some special provisions to help the FDA better monitor new dietary supplements being released on the market and to help ensure their safety. One such provision is the new ingredient notification process. Before DSHEA was passed in 1994, there were already several dietary supplements being sold on the market. The ingredients in these supplements, mostly vitamins, minerals, herbs, amino acids or extracts, were grandfathered in. After 1994, if a company is introducing or adding any new ingredients to a supplement, it is required to submit a notification form to the FDA at least 75 days before the product is released. More information on the premarket notification form for dietary supplements and its requirements is available on the FDA website.
The FDA also has specific guidelines that manufacturers must adhere to regarding dietary supplements under the Good Manufacturing Practices amendment, which was finalized on DSHEA in 2007. Under the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, which also went into effect in 2007, after dietary supplements are released on the market, manufacturers are required to report and keep record of any adverse reactions received and must further report any that are serious. The FDA is supposed to closely monitor these reports and determine whether there are any patterns or concerns that warrant further action be taken by the agency (i.e. consumer warnings or taking the product off the market completely).
What should consumers who are taking prescription medications do if they are worried that their dietary supplements will have adverse reactions to their medications?
If consumers are ever worried about how a dietary supplement will interact with their medications, talk to a doctor or a pharmacist. According to MacKay, a handful of medications should be closely monitored if they are being used with dietary supplements. These are drugs with a narrow therapeutic index, the ratio that compares amount of a drug that produces the desired effect in patients to the amount that causes no effect or an adverse effect. Common drugs with a narrow therapeutic index include digoxin, warfarin and lithium carbonate. “Consumers need to communicate everything they are taking with their health care professionals,” MacKay said. “Not just dietary supplements, but many types of foods also can have adverse reactions with certain medications.” Pharmacy technicians can also help by asking a customer if they are taking any dietary supplements when they pick up a prescription drug known to have a narrow therapeutic index.
What’s the story on these dietary supplements that have been found to contain steroids, male enhancement drugs like Viagra and other risky ingredients?
Under FDA rules, dietary supplements are not allowed to have any kind of chemical compounds that are classified as a drug or act as a drug. Most dietary supplements are nothing more than vitamins, multivitamins, minerals, nutritional supplements such as fish oil or herbal products such as St. John’s wort. According to MacKay, however, a small minority of illegitimate manufacturers of dietary supplements, mostly online companies, are placing drugs such as Viagra (sildenafil) or chemical compounds such as steroids in their products and marketing them as dietary supplements. These are not real dietary supplements, and they are illegal under the FDA rules and DSHEA. Most often, these products are marketed as weight loss supplements, bodybuilding supplements and sexual enhancement supplements.
MacKay advised consumers to use good judgment when purchasing these types of supplements, especially when purchasing online. The FDA monitors all claims made on food and drug product labels. If the agency finds a product label has anything false or misleading on it, the product is considered “misbranded.” The FDA takes action against any product it believes has been misbranded. However, the Federal Trade Commission (FTC) regulates the way supplements are advertised and marketed. The FTC has also released letters and pamphlets to help consumers watch out for supplements that are marketed illegally. The FTC’s Red Flag Bogus Weight Loss Claims Guide highlights some buzzwords and phrases consumers should watch out for when purchasing a dietary supplement.
What measures can people take to protect themselves against illegal or unsafe dietary supplements?
“Buy from companies you know and trust,” MacKay said. Also, pay close attention to the way the supplement is marketed. True dietary supplements are supposed to promote good health and wellness. If the marketing message sounds too good to be true, it usually is. Consumers and pharmacy professionals who encounter a product they believe is being marketed illegally as a dietary supplement should report the manufacturer to the Better Business Bureau. They can also research a business and find out if it is accredited by the BBB by looking it up on the BBB website www.bbb.org. CRN works closely with the BBB’s National Advertising Division and the FTC to target companies that use deceptive practices to market their supplements. The U.S. Pharmacopeia also has a verification program where companies can put their products through testing, audits and reviews by USP staff to earn the USP Verified Mark of Approval. A list of USP Verified dietary supplement manufacturers is available on the USP Verified program information page.
Did you have a question for CRN and Dr. MacKay that we did not cover?
Pharmacy technicians with their own questions about dietary supplements can visit the Council for Responsible Nutrition website at www.crnusa.org or email their questions to the CRN staff by visiting their bio pages.
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