VMS industry joins FDA in crackdown on SARMs
WASHINGTON — The dietary supplement industry’s leading trade associations and the U.S. Anti-Doping Agency on Wednesday joined in support of the U.S. Food and Drug Administration’s recent actions to protect consumers from body-building products containing Selective Androgen Receptor Modulators (SARMs) illegally marketed as dietary supplements.
"We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients," advised Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, FDA. "Body-building products that contain selective androgen receptor modulators, or SARMs, have not been approved by the FDA and are associated with serious safety concerns, including potential to increase the risk of heart attack or stroke and life threatening reactions like liver damage,” he said. “We will continue to take action against companies marketing these products to protect the public health."
The FDA recently issued warning letters to Infantry Labs, IronMagLabs and Panther Sports Nutrition for distributing products that contain SARMs.
"SARMs are dangerous and illegal, and they pose an immediate risk to consumers, jeopardize the careers of athletes, and have no place in any sports nutrition regimen," the trade associations noted in a joint release.
Together, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association, the United Natural Products Alliance and USADA shared concerns about these products and are supporting FDA’s efforts to crack down on companies unlawfully manufacturing products containing SARMs.
Prohibited under the S1 Anabolic Agent category of the World Anti-Doping Agency Prohibited List, SARMs have raised serious concerns for FDA, USADA and the legitimate dietary supplement industry, as they have the potential to be misused for athletic performance enhancement due to their anabolic properties and their ability to stimulate androgen receptors in muscle and bone. SARMs are not approved for human use or consumption in the United States, but, despite being prohibited, SARMs have been found in a number of adulterated products falsely labeled as dietary supplements. Some products list the ingredient as
“Ostarine” — one ingredient in the class of SARMs — but the ingredients may also go by an alternative name, or be entirely undisclosed on the label.
In addition to alerting consumers, the five supplement industry trade associations have taken action to remind member companies of the responsibility to ensure that SARMs are not used in their products. FDA regulates the dietary supplement industry and this advisory puts companies on notice that those failing to comply with the law are subject to strict enforcement actions.
Additionally, the advisory serves as a reminder to consumers — particularly amateur and elite athletes — to educate themselves on the dangers SARMs-tainted products pose. There are legitimate sports nutrition dietary supplements that are safe, beneficial and not prohibited by WADA, and it is important for all consumers, including athletes, to engage in due diligence when deciding which products to use and which companies to purchase products from.
Q&A: Nutrisystem emphasizes nutrition’s role in diabetes management
For years now Nutrisystem has provided a comprehensive nutrition solution at retail that diabetes consumers can use to better manage their condition. Drug Store News recently checked in with David Burton, executive vice president of operations and retail at Nutrisystem, to explore how that proposition has been trending at retail and to uncover any new product offerings coming down the pipeline. Here's what he had to say:
Drug Store News: How has Nutrisystem’s diabetes offerings been trending? What is the consumer need that Nutrisystem meets with these products?
David Burton: Nutrisystem is the only company in retail today that provides a full-diet solution for losing weight to manage diabetes. In addition to meals and snacks, Nutrisystem provides a comprehensive shopping list to allow a one-stop shopping experience at the retail level.
The CDC reports that more than 30 million people in the United States are living with diabetes and, according to Nielsen, these consumers or consumers with diabetes spent $592 million on OTC-related products in 2015. Unfortunately, this is a growing trend with real health implications. A diabetes diagnosis can be overwhelming. From managing your diet to a wide range of possible new concerns including weight loss, eye health, kidney health, heart health and circulatory health. That’s where we come in and can help. Nutrisystem D is based on the nutritional guidelines of the American Diabetes Association and specially designed with an optimal balance of protein, fiber and slow-digesting carbs to help minimize blood sugar spikes and satisfy hunger. It’s easy to follow and offers free weight loss counseling and exercise tips, along with access to a Certified Diabetes Educator along the way.
DSN: What are some of Nutrisystem’s other key offerings?
Burton: Our most popular item is our 7-day weight-loss kit that contains seven breakfasts, seven lunches and seven snacks — it’s designed for people who need structure on their weight-loss journey, while allowing some flexibility to enjoy dinners on their own. The 7-day weight-loss kit contains an easy-to-follow meal planner as well as healthy dinner recipes.
In addition to the kit, we have a line of single items designed for the consumer looking to supplement their meals to help keep their blood sugar levels steady throughout the day. We are always looking at new ways to innovate in this category to ensure our foods are appealing and on trend, so we have low-glycemic items like soft-baked chocolate brownies, soft-baked blueberry muffins and soft-baked cinnamon buns — all contain 6 g of fiber without any artificial sweeteners or flavors. And of course, a favorite is our chocolate chip cookies — a perfect portion-controlled snack for consumers with diabetes.
DSN: What should retailers know to maximize sales among their diabetic consumers?
Burton: Because these customers can be overwhelmed by all that is required, diabetes education, management and easy solutions can be presented at retail. Enlist the expertise of in-store healthcare professionals such as the pharmacist or retail dietitian to help. Some retailers are partnering more with communities to do A1C testing on site, and are promoting nutrition through online content, cooking demos and recipe suggestions right in store.
DSN: What’s the bottom line?
Burton: In addition to the 30 million people living with diabetes, 84 million people — or more than 1-out-of-3 adults — have been diagnosed with prediabetes, which for many will progress to diabetes. Weight loss and lifestyle changes can halt the progression to Type 2 diabetes. The AACE states in its diabetes algorithm “the primary goal of prediabetes management is weight loss” and Nutrisystem is the only product on the shelf today that provides the consumer with an easy-to-follow, clinically tested, safe and healthy weight-loss program specifically designed for those with type 2 diabetes or pre-diabetes.
Zicam Cold Remedy Medicated Fruit Drops gives cold-fighters another choice
BRIDGEWATER, N.J. — Zicam on Tuesday announced the national launch of Zicam Cold Remedy Medicated Fruit Drops, offered in an assortment of fruity flavors.
“Coming down with a cold is an unpleasant experience; in addition to dealing with symptoms, we can also feel more isolated and lonely,” stated M'lou Walker, CEO Zicam. “At Zicam, we are always looking for ways to show our consumers that we are there for them. We are passionate about helping people get back to feeling better, so they can enjoy time with their family and friends. With our new Medicated Fruit Drops, we hope to bring a delectable mix of flavor into cold shortening, while making a difference in people’s lives.”
Zicam Cold Remedy Medicated Fruit drops are non-drowsy and non-habit forming. The soft assorted fruit drops come in a mix of three distinct flavors: orange, lemon and cherry, and contain pectin, a premium gelling agent that helps prevent the product from melting and sticking together. Each container holds 25 fruit drops, and can be found at major retailers nationwide.
"We recognize that consumers are looking for more choices in form and flavor when in the cold aisle, so we are always innovating new ways to shorten colds,” said Lori Norian, vice president marketing at Zicam. "We care about those using our products and with our new Medicated Fruit Drops we aimed to create another delicious, yet unique, way to get better faster. Early results are showing that consumers agree.”