HEALTH

GNC absolved of wrongdoing in case against USPLabs

BY Michael Johnsen

PITTSBURGH — As part of an agreement with the Department of Justice in connection with that agency's investigation into USPLabs, GNC Holdings has been absolved of knowingly selling products in violation of the Food, Drug and Cosmetic Act, the specialty channel retailer announced Wednesday.

"We are pleased to have reached an agreement with the DOJ related to certain products manufactured by USPLabs which were removed from GNC's shelves years ago," GNC stated. "The DOJ and Food and Drug Administration concluded in the agreement that GNC relied on the representations and written guarantees of USPLabs that it was in full compliance with FDCA and applicable state laws with respect to the ingredients contained in its products," the Pittsburgh-based retailer added. "Ultimately, the DOJ found sufficient evidence that USPLabs provided false assurances and information and fake documentation to third parties, including GNC. The DOJ andFDA also concluded that GNC was unaware of any information that the products manufactured by USPLabs violated the FDCA, while recognizing GNC's representation that it did not knowingly sell products that violated the FDCA."

As part of the agreement, GNC will take a number of actions to broaden industry-wide knowledge of prohibited ingredients and improve compliance by vendors of third party products. "GNC remains committed to maintaining robust compliance policies and procedures and holding third party vendors and suppliers accountable for those standards," the company stated.

The action ends a year-long link between USPLabs and GNC. GNC had dropped the vendor from its shelves in November of last year in the wake of a DOJ investigation into USPLabs — known for its workout and weight loss supplements, which it sold under such names as Jack3d and OxyElite Pro — that produced an 11-count indictment against USPLabs and several of its top executives. The case against USPLabs was part of a broader crackdown on outlier supplement companies.
 

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Renew Life Probiotics raises gut-wrenching issue for women

BY Michael Johnsen

CLEARWATER, Fla. — It's a gut-wrencher of an issue — as many as 72% of women have experienced an occassional digestive issue in the past year, including the occasional constipation, gas or diarrhea, yet the majority of those women (64%) aren't willing to disclose that "reveal" to their closest friends, according to a survey commissioned by Renew Life Probiotics.

In response, Renew Life Ultimate Flora Probiotics is launching the "Get to Know Your Gut" education campaign to put the taboo topic on the table in an effort to educate women about digestive health, how vital its ecosystem is to the body's overall health and well-being, and the benefits everyone can reap from a daily dose of probiotics.

"Many women are shocked to learn that the gut is the center of their overall health and wellness. It affects the entire body including digestion and immunity," stated Ellie Krieger, Renew Life Probiotics spokesperson and a culinary nutritionist, host of "Ellie's Real Good Food" show and author to several healthy cookbooks.

Nearly a quarter of women (22%) don't consider the status of their digestive health when they think about their overall health and wellness, which suggests they may be severely underestimating the power of their gut.

"Some women are unaware that stress (21%), diet (16%), aging (43%) and even their living environment (52%) are factors that can upset the bacterial equilibrium in the gut, which can make it difficult to feel one's best," commented Katie Keil, director marketing, Renew Life Probiotics. "Women need to know there are solutions to their digestive struggles."

There are more than 100 trillion live bacteria cultures of many diverse strains inside the digestive tract that need to be balanced in order to keep the body healthy. There are simple, everyday activities that support healthy digestion, such as eating a healthy diet, including probiotic-rich foods like kefir, sauerkraut, kimchi, and yogurt, drinking plenty of water, staying physically active and managing stress. Nutrition experts also agree that a probiotic supplement is the key to replenishing the gut with good bacteria, and yet a third of women (34%) report that they don't clearly understand the role probiotics play in the body.

"It's important to maintain gut health all year long. I generally take a food-first approach when it comes to getting the nutrients you need, but probiotic supplements offer a distinct advantage for gut balance that is difficult to get with food alone, so I recommend them along with getting more probiotic-rich foods into your life," Krieger said. "During the winter season, 63% of women look for ways to support their immune system, and with 70% of one's natural immune system support in the digestive tract, taking a probiotic is a good place to start."

The survey was conducted online within the United States by Harris Poll on behalf of Renew Life Probiotics from Nov. 9-11, 2016 among 1,127 U.S. women ages 18 and older.

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FDA to make hearing aids available OTC

BY Michael Johnsen

SILVER SPRING, Md. — The U.S. Food and Drug Administration on Wednesday announced its commitment to considering a category of over-the-counter hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.

In addition, the agency issued a guidance document explaining that it does not intend to enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids.

“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,” stated Robert Califf, FDA Commissioner. “The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”

The FDA has cited that hearing loss affects some 30 million people in the United States and can have a significant impact on communication, social participation and overall health and quality of life. Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention.

At present, hearing aids often cost more than $2,000 a piece, and such barriers to distribution channels may limit new entrants who could achieve technological breakthroughs that could offer a greater variety of lower-cost hearing aid options to those suffering from hearing loss. The regulation requires that all prospective hearing aid users have a medical evaluation by a licensed physician to determine the cause of hearing loss and whether medical or surgical treatments would be more appropriate. Individuals 18 and up may waive the requirement for a medical evaluation by signing a waiver statement.

Under the new guidance, the FDA will continue to enforce the medical evaluation requirement for prospective hearing aid users under 18. Under the FDA’s hearing aid regulations, hearing aid labeling must include information about medical conditions that should be evaluated by a licensed physician. In addition, the FDA requires that information and instructions about hearing aids be provided to consumers before any purchase from a licensed hearing aid dispenser.

The guidance is “Immediately in Effect,” which means it is implemented without prior public comment because it presents a less burdensome policy that is consistent with public health. The public can still comment on the guidance, and the FDA will consider all comments received and revise the guidance document as appropriate.
 

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