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Industry trade associations deliver primer on supplement regulation to Capitol Hill staffers

BY Michael Johnsen

WASHINGTON — Capitol Hill staffers this week learned useful tips from a medical expert on reading and understanding dietary supplement labels, and received a primer on the depth of regulation behind dietary supplement labeling during an educational briefing held by the Congressional Dietary Supplement Caucus in cooperation with the leading trade associations representing the dietary supplement industry, the group announced Friday. 

The Hill staffers in attendance at the DSC briefing learned details about what information must appear on a dietary supplement label and what each item means, including: the statement of identity; net quantity of contents; supplement facts with nutrition information for each ingredient; manufacturer or distributor information; complete listing of ingredients; safety information; FDA disclaimer; claims/benefits; and cautions/warnings/notices. They also learned the meanings of key terms such as: Estimated Average Requirements; Recommended Dietary Allowance; Adequate Intake; Daily Value; and tolerable upper intake level — making this DSC lunch briefing an opportunity for staffers to learn valuable information for their personal use and to help them better understand issues related to policymaking.

DSC educational briefings are held throughout the year, featuring nationally recognized authors, lecturers or authorities on health and wellness who provide tips and insights for better nutrition, including how dietary supplements can contribute to a healthier lifestyle. These briefings also help to educate congressional staff about constituent access to safe and beneficial dietary supplements, and legislative and regulatory issues associated with these products. In addition, DSC members receive regular updates on any new and ongoing developments in the dietary supplement arena.

The DSC is comprised of associations including the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance. 

 

 

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FDA issues warning to consumers, healthcare professionals on the use of teething topicals for infants

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Thursday notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a boxed warning to be added to the prescribing information label to highlight this information. 

The agency also encouraged parents and caregivers to steer clear of over-the-counter teething remedies like benzocaine "because some of them can be harmful." "FDA previously communicated about safety concerns related to use of OTC topical benzocaine teething preparations," the agency stated. "In 2011, we warned that using OTC benzocaine gels for teething or mouth pain can cause a rare but serious condition called methemoglobinemia. 

“Today’s suggestion from FDA regarding [OTC ingredients like] benzocaine does a disservice to parents and caregivers who use FDA-approved OTC gel and liquid medicines containing benzocaine to treat their children suffering from teething pain," the Consumer Healthcare Products Association released in a statement. "Consumer updates are not the appropriate means to alter the indicated use for FDA-approved medicines, and this suggestion creates confusion among consumers and healthcare providers as well. In 2012, the FDA advised parents and caregivers not to use benzocaine products for children younger than 2 years, unless under the advice and supervision of a healthcare professional. They provided no data as to why they changed the recommendation."

"Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes," the agency stated. "When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying."

In 2014, the FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2% solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions. 

Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death, the agency warned.

 

 

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FDA issues warning on certain OTC acne products

BY Antoinette Alexander

WASHINGTON — The Food and Drug Administration has issued a warning that certain OTC topical acne products may cause rare but serious and potentially life-threatening allergic reactions or severe irritation. 

The FDA stated that consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips or tongue.  Consumers should also stop using the product if they develop hives or itching. 

These hypersensitivity reactions differ from the local skin irritation that may occur at the product application site, such as redness, burning, dryness, itching, peeling, or slight swelling, that are already included in the Drug Facts labels, the agency stated.


Based on the information reported to the FDA, it cannot determine if the serious hypersensitivity reactions were triggered by the acne products’ active ingredients — benzoyl peroxide or salicylic acid — the inactive ingredients, or by a combination of both. The hypersensitivity reactions may occur within minutes to a day or longer after product use. 
According to the FDA’s statement, the OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands. They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs and other products.


Before using an OTC topical acne product for the first time, consumers should apply a small amount to one or two small affected areas of the skin for three days, the FDA stated.  If no discomfort occurs, then the product can be used according to the directions on the Drug Facts label. 

 

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