HEALTH

Natrol introduces Cholest Intercept aimed at lowering LDLs

BY Michael Johnsen

CHATSWORTH, Calif. Natrol on Monday announced the introduction this month of Cholest Intercept, which according to the company is a natural, safe and effective way to lower LDL cholesterol by as much as 15 percent in as little as 4 weeks while also preserving HDL cholesterol.

“Cholest Intercept contains an advanced formula of plant sterols that can actively compete with food cholesterol for absorption in the small intestines,” stated Michael Yatcilla, Natrol vice president of research and development. “When Cholest Intercept is taken with meals, the body absorbs less cholesterol from fish, meat, dairy, eggs and other animal products. This results in lower levels of LDL cholesterol in the blood.”

Cholest Intercept also contains B-vitamins which have been shown to help maintain normal homocysteine levels that are already in the normal range, Yatcilla added.

According to Natrol, the company is promoting the product launch through a buy-one-get-one-free offer at Rite Aid through Sept. 27.

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FDA responds to WHO’s query on ten medications

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration last week requested comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 10 drugs, including the over-the-counter cough suppressant dextromethorphan. The information will be utilized by FDA in its preparation of the United States’ response to a World Health Organization query.

Dextromethorphan is the only OTC medicine on WHO’s list. The other medicines being examined include:

  • Gamma-hydroxybutyric acid, a narcolepsy drug marketed in the United States under the brand name Xyrem (Jazz Pharmaceuticals) and controlled under Schedule III status (drugs with recognized medical use with a moderate to low incidence of dependence);
  • the anesthetic ketamine, controlled under Schedule III status;
  • benzylpiperazine, an illegal drug in the United States;
  • trifluoromethylphenylpiperazine, not marketed in the United States;
  • meta-chlorophenylpiperazine, not marketed in the United States;
  • methoxyphenylpiperazine, not marketed in the United States;
  • methylenedioxybenzylpiperazine, not marketed in the United States;
  • the reagent gamma-butyrolactone, not marketed in the United States, but controlled as a list I chemical ; and
  • the solvent butanediol (a scheduled substance in some states but not nationally).

WHO has called for information on these drugs to ascertain whether or not the organization should recommend that certain international restrictions be placed on distribution of the medicines.

Comments submitted to FDA are due Oct. 6. WHO meets April 20-23, 2009, to discuss the issue.

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Senate judiciary passes anti-‘smurfing’ legislation

BY Michael Johnsen

WASHINGTON The Senate Judiciary Committee on Thursday passed the Methamphetamine Production Prevention Act, introduced by Sens. Dick Durbin, D-Ill., and Chuck Grassley, R-Iowa, Grassley’s office stated in an announcement.

The legislation addresses the practice of “smurfing,” where individuals looking to circumvent federal purchase restrictions on pseudoephedrine by the maximum quantity allowed across several retailers, by making it easier for pharmacy operators to use electronic logbook systems in their sale of PSE products.

“Smurfing pseudephedrine products from store to store in city to city is a growing problem, especially in communities that border another state,” stated Grassley. “When we wrote the Combat Meth Act, we didn’t account for these unscrupulous individuals who have learned that if they provide false information or visit multiple stores, tracking and arresting these people is more difficult. … An electronic logbook will be a tremendous asset for local law enforcement and businesses as they work to end the devastating impact of meth on our communities.”

Today’s legislation revises the technical logbook requirements found in the federal Combat Methamphetamine Epidemic Act, which passed in 2006. The Durbin-Grassley bill would change the Combat Meth Act to facilitate the use of electronic logbooks instead of written logbooks. For instance, the bill would revise the Act’s purchaser signature requirement to allow signatures to be obtained and stored on paper when the rest of the logbook information is captured electronically. This would make electronic logbook systems far more cost-effective without hurting law enforcement efforts. The bill would also allow for the use of bar code reader technology, and would revise the current requirement that each purchaser “enter” his or her name and address into a logbook so that retailers can type in the information electronically.

The legislation has been endorsed by numerous organizations, including the National Narcotics Officers’ Associations’ Coalition, the National Criminal Justice Association, the National District Attorneys Association, the Consumer Healthcare Products Association and the National Association of Chain Drug Stores.

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