FDA warns consumers about body-building products that contain steroids, related substances
ROCKVILLE, Md. The Food and Drug Administration on Tuesday issued a Public Health Advisory warning consumers to stop using body-building products that are represented as containing steroids or steroid-like substances and oftentimes misbranded as dietary supplements.
The agency also issued a Warning Letter to American Cellular Laboratories for marketing and distributing body-building products containing synthetic steroid substances. Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.
The PHA notifies consumers and health care professionals that the FDA has received reports of serious adverse events associated with the use of body-building products that claim to contain steroids or steroid-like substances. Those adverse events include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung). The PHA also advises consumers to stop taking body building products from any manufacturer that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.
The FDA has received five adverse event reports, including serious liver injury, in men taking products marketed as dietary supplements by American Cellular Laboratories, including TREN-Xtreme and MASS Xtreme. Acute liver injury is generally known to be a possible side effect of using products that contain anabolic steroids. Some of the cases resulted in hospitalization, but there were no reports of death or acute liver failure.
“Products marketed for body-building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” stated FDA commissioner Margaret Hamburg. “The FDA is taking enforcement action today to protect the public.”
The products listed in the Warning Letter to American Cellular Laboratories, include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme,” and are sold on the Internet and in some stores. These products, which claim to contain steroid-like ingredients but in fact contain synthetic steroid substances, are unapproved new drugs because they are not generally recognized as safe and effective. In addition, the products are misbranded because the label is misleading and does not provide adequate directions for use.
Bayer Consumer Care launches virtual march against breast cancer
MORRISTOWN, N.J. Bayer Consumer Care last week announced an initiative encouraging women to join a virtual march against breast cancer as part of its One A Day Women’s Take A Stand Campaign.
Through the end of October, women will have the opportunity to show that they’re taking a stand against breast cancer by going to www.oneaday.com, and creating a customizable character in honor of someone special.
According to a recent Yankelovich survey, although a large majority of women know there are simple steps they can take to support breast health, few women are taking the necessary actions. As many as 80% of the women surveyed have been personally affected by breast cancer or know someone who has been.
The survey also found that 1-in-5 women who support breast health or breast cancer awareness causes wish they could do more, and 60% of women who have not supported breast cancer organizations and causes say they lack the time or money.
“Joining the Take A Stand virtual march provides a quick, easy and free way for women to help raise funds to support breast cancer awareness and research,” Bayer stated. “For each character created, the One A Day brand will make a donation to a breast cancer cause that will be determined by an online vote.”
The organizations to be included in that vote are: The Breast Cancer Research Foundation, the American Cancer Society and the National Breast Cancer Foundation.
“This program is part of our continued efforts to increase awareness about the importance of supporting breast health,” stated Barton Warner, VP marketing and new business for Bayer Consumer Care. “Last year One A Day Women’s woke women up about breast cancer through the One A Day Women’s Wake-Up Call program, and now it’s time women answer the call by taking a stand.”
BDI Marketing announces new wave of energy drinks
CARMEL, Ind. BDI Marketing announced the release of a new series of products, including its new 357 Super Magnum Energy Shot, Xtreme Energy Rush and Top Gun sexual stimulant pills in a new 2-oz. liquid shot.
BDI’s 357 Super Magnum Energy Shot provides consumers with enough caffeine to stimulate and fuel the body to perform at unparralled levels throughout the entire day but without the fat, sugar, carbohydrates or calories, the company said.
In celebration of the 10th anniversary of the introduction of its popular Top Gun sexual stimulant pills, BDI is now offering the product in new two-ounce liquid shots, available in Cherry Passion flavors. The pill is aimed to provide consumers with enhanced libido and increased energy and endurance.
Xtreme Energy Rush is packed with three-times the strength of a single cup of coffee; a triple strength punch that provides the body with a shot of long lasting energy.
The new products join BDI’s ever-growing family of incredibly popular liquid, gum and capsule Mini Thin energy products to provide consumers with a delicious option to high-sugar energy drinks.