Q & A
On April 9, 2013, The Dr. Oz Show aired a segment on vitamins. Only one guest was featured, but a lot of questions were raised. CRN would have liked the opportunity to participate in the show to answer some of those questions. Although we offered, the show’s producers chose not to include us in the conversation.
Q. Are dietary supplements regulated?
A. Yes. Dietary supplements are regulated. The FDA’s authority over dietary supplements allows it to inspect manufacturing facilities, to review labeling for accuracy and the inclusion of required information, and to monitor products for safety by requiring manufacturers to report serious adverse events to FDA. The Federal Trade Commission (FTC) has authority over advertising and marketing claims and challenges claims that are misleading, not truthful or not substantiated with credible scientific evidence.
Q. What are Good Manufacturing Practices (GMPs)?
A. FDA has inspection authority to ensure quality throughout the manufacturing process, under the agency’s GMP regulations, issued in 2007 and made effective for all companies in June 2010. GMPs set standards for testing and manufacturing. GMPs include:
- Raw materials quality assurance;
- Record-keeping of substances throughout the manufacturing process;
- Standards for cleanliness and safety;
- Qualifications of manufacturing personnel;
- Finished product specifications, and
- Production and process controls.
GMPs ensure that what’s on the label must be in the bottle.
Q. What is the reason a product might have more of an ingredient in it than what the label states?
A. In order to be compliant with label claims, a manufacturer must ensure that a product contains at least the labeled amount of each ingredient up until the date of expiration, if an expiration date is listed on the bottle. Vitamins are a category of food, and unlike pharmaceutical products, they naturally lose activity/potency over time, so a manufacturer may need to increase the amount of the ingredient—while still maintaining safe levels—to ensure compliance with the law. CRN Q&A A Response to The Dr. Oz Show, April 9, 2013
Q. How much of an ingredient is too much?
A. The Institute of Medicine identifies Upper Tolerable Levels (ULs) for nutrients. The UL is a point at which no adverse effects are known. Exceeding the UL for a nutrient does not automatically trigger a negative effect, but some adverse effects are observed at these higher levels so it’s best to stay under the UL for a particular nutrient. In general, there is a wide margin between a Recommended Dietary Allowance and a UL. When considering the ULs, you should take into account how much of that nutrient you are getting from all sources, including conventional foods and dietary supplements.
Q. Is it true that I only want to buy products that dissolve completely in water?
A. No, and in fact, while the water test demonstrated on the show made for good TV, it is misleading. Here’s why. When a dietary supplement is ingested, it is exposed to digestive enzymes, stomach acid and the churning of the stomach. The biological process that dissolves a dietary supplement is by no means replicable in a glass filled with warm water and a stirrer. In fact, the United States Pharmacopeial Convention (USP), a standard-setting body that was referenced on the show, uses a test for dissolution that is quite a bit more comprehensive—and more likely to replicate actual digestion—than the glass of water depicted on the show.
Q. What do I need to know about calcium and lead?
A. All minerals, including calcium, contain some amount of lead. Although California generally limits the amount of lead in many consumer products to .5 mcg/1000 mg, the California Attorney General’s office has determined that acceptable levels for calcium supplements should be composed of naturally occurring levels and what is technically feasible to achieve. Therefore the state of California generally applies a level of 1.3 mcg/1000 mg of calcium for these products. Even this allowable level is a unique and restrictive standard, not applied anywhere else in the U.S. In referring to the California requirement for lead levels, not only did Dr. Oz’s guest refer to an incorrect standard, but also he was wrong to advise that companies would need a warning label if they surpassed the .5 mcg/1000 mg level. This unique standard for lead in calcium products is not clearly listed on the website of the California Attorney General or the California Office of Environmental Health Hazard Assessment because the standard was part of a consent decree that California reached with the individual manufacturers, so it is understandable that Dr. Oz’s guest was not aware of the new standard.
Q. What is a proprietary blend?
A. A proprietary blend is a combination of ingredients, often herbal, that is exclusive to a manufacturer. The law requires the manufacturer of a proprietary blend to list on the product label the ingredients contained in the product in descending order of their amount—just like a can of soup; however, the label does not need to list the absolute amounts of each ingredient because the specific formula is considered the company’s intellectual property. CRN Q&A A Response to The Dr. Oz Show, April 9, 2013
Q. Do I need to stay away from proprietary blends?
A. Not necessarily. It’s a personal choice. A manufacturer that chooses to market a proprietary blend must still comply with the law, and ensure that the ingredients levels —though proprietary—are safe for consumer use. Like all dietary supplements, one that contains a proprietary blend can be removed from the market by FDA if it is found to be unsafe. Consumers of dietary supplements, whether they contain proprietary blends or not, should purchase from companies and brands they trust to stand behind the safety and quality of their products.
Q. What do I need to know about third party testing?
A. There are several certification programs available including from CRN member companies HFL Sport Science, NSF, Nutrasource Diagnostics and USP that independently review the manufacturing process or finished products for supplement makers. Seals or certifications are just one way that companies can invest in their brand, but the absence of a seal does not mean that a product is of poor quality.