Weight Management is Everybody’s Responsibility, Especially Manufacturers

8/15/13

“An apple a day keeps the doctor away” is what I grew up with. And there was that pyramid telling us to eat some bread, some fruit and veggies, and a little protein and dairy while being sparse with the fats and oils. They even included “sweets,” as if it’s ever really OK to eat sugary foods.

The USDA is responsible for the food pyramid (among many other things) and has graciously set guidelines in effort to keep the U.S. strong and healthy. They even have a web site,www.choosemyplate.gov, to help us make good decisions about what to eat and drink. The most up-to-date food pyramid is no longer a pyramid at all, but a plate that shows 25 percent designated to proteins, 25 percent to grains, ~35 percent to veggies, and the rest to fruits. There is a small circle offset (like a glass) where dairy is designated.

While this is all very helpful, today weight management can be approached in so many directions, from the extreme to the “Oh, that makes sense.” I don’t have to tell you where these options land on the spectrum.

–Surgical Options

–Pharmaceutical Drugs

–Medical Weight Loss

–Non-Medical Weight Loss

–Fad Diets

–Dietary Supplements

–Diet and Exercise

As if all those options aren’t confusing enough for consumers, FDA has identified over 400 weight-loss/dietary supplements sold by unscrupulous companies since 2008, that when analyzed, contained undeclared prescription drugs like Sibutramine and/or its close analogs. While this liability rests on the shoulders of nearly every point in the chain of custody, manufacturers have a particularly important role in combating this threat to consumer confidence and safety. In a letter to industry, the FDA “reminds dietary supplement companies of their obligation under current good manufacturing practice (cGMP) to establish and meet specifications on those types of contamination that may adulterate or lead to adulteration of the finished batch of dietary supplement (see 21 CFR 111.70(b) and 111.75(a)).”The American Herbal Products Association (AHPA) has created a website (www.keepsupplementsclean.org) to keep the dietary supplement industry informed on issues related to illegal tainted products being sold as “dietary supplements.”

The problem isn’t as innocent as the mistaken botanical ingredient or more maltodextrin than the spec lists. Somewhere, at an ingredient supplier near you, an employee is fortifying a weight-loss product with undeclared prescription drugs to add efficacy and increase sales with blatant disregard to the health and safety of the end user. With guidance available and expectations clear, the manufacturer has the power to avoid mistakes of complacency that lead to tainted finished products. Even though the undeclared drugs and their analogs present themselves as moving targets, a handful of independent testing labs exist and are diligently doing their best to stay ahead of the unscrupulous. Panels of tests are available for common weight-loss supplement adulterants—just as there are for the sexual enhancement products and bodybuilding products—that change regularly to meet the need of the industry. Still, cheaters cheat and willful ignorance is bliss, making the job of the manufacturer not only to produce the highest quality products possible but to also be proactive in searching for undeclared prescription drugs in high profile products like weight-loss supplements.

Categories: Analytical Testing, Botanical Identification, Product Verification/Validation, Regulations