Monthly Archives: June 2017

Red yeast rice is a dietary supplement designed to help treat hyperlipidemia and heart disease. Americans spend about $20 million a year on the product, which contains the same statin (monacolin K) as prescription lovastatin.

Despite this, the supplement is regulated as a food, not a drug. But a new study published in the European Journal of Preventative Cardiology has shown that even after the FDA implemented good manufacturing practices, the amount of the active ingredient in red yeast rice can differ widely from brand to brand, even reaching prescription-strength levels.

The study looked at 28 different brands of the supplements, each on sold in at least one of four major chainsGNC, Walgreens, Walmart, and Whole Foods.

Two of the brands contained no monacolin K. The brands that did contain monacolin K varied widelyfrom 0.09 to 5.48mg per 1200mg of red yeast rice. Over one-third of the brands tested contained more than 2 mg of monacolin K per 1200 mg of red yeast rice. This means that consumers could be ingesting 0.09 to 10.94mg of monacolin K per day, a difference of 120-fold. The study found that the dosages for some brands lined up with the dosages on prescription lovastatin tablets, which are produced in 10 mg, 20 mg, and 40 mg dosages.

No brand listed the amount of the monacolin K and only two brands warned the consumer not take the supplements with prescription statins. Previous studies have shown that consumers may suffer from the same adverse effects while taking red yeast rice as they would when taking a statineffects possibly exacerbated when taken with another prescription statin.

So why all the variance? Red yeast rice is made by fermenting rice with different strains of Monascus spp., also known as ang-khak rice mold. As with any fermented product, minor differences in the process can lead to large differences in the final result. Authentic Chinese red yeast rice generally contains small amounts of monacolin K, but certain mutant strains of yeast can produce higher levels of the statin.

FDA regulations say that red yeast rice with higher levels of monacolin Khigher than 4 mg per dayare not supplements but unapproved drugs. Six brands tested in the study would qualify as unapproved drugs.

The study only tested one batch of each supplement, but the authors warn that even from batch to batch the amount of monacolin K is most likely variable. The study also only examined monacolin K, whereas red yeast rice can have multiple statin-like monacolins, potentially creating additional problems.

See more here:

Dietary Supplements or Unapproved Drugs? - ModernMedicine

For the fiscal year that ended Sept. 30, 2016, FDAs Office of Dietary Supplement Programs (ODSP) had a budget of US$4.6 million to police an industry with tens of billions of dollars in sales and tens of thousands of products on the U.S. market.

The Council for Responsible Nutrition (CRN), a trade organization in Washington representing the dietary supplement industry, is seeking $5 million above current funding and has been in talks with lawmakers who hold the governments purse strings.

Mike Greene, senior vice president of government relations with CRN, said his organization has met with more than 50 appropriators on Capitol Hill.

Generally, everyone we meet withRepublican or Democratis supportive of the idea," he said. They understand this a growing industry."

Explained Greene in the first of two interviews on the subject: Were hopeful we get funding now, but if we dont or if we get less funding, well be focused on this over the long haul, probably the next three years, working to ensure that adequate funding is given to the Office of Dietary Supplement Programs."

ODSPs director, Steven Tave, and his staff of 25 in College Park, Maryland, face a daunting task: policing a $41 billion industry.

In 1994, the year Congress passed the Dietary Supplement Health and Education Act (DSHEA), there were an estimated 4,000 products on the market, according to FDA. Twenty years later, the number of dietary supplements on the market exceeded 85,000, according to FDA estimates in 2014.

In late 2015, FDAs Division of Dietary Supplement Programs was elevated to an office. As FDA explained in its FY18 budget report to Congress, the move further enhances the effectiveness of dietary supplement regulation by allowing ODSP to better compete for government resources and capabilities to regulate this rapidly expanding industry."

However, Greene said to some extent, there was no immediate follow-up to ensure FDA supplement officials received additional resources.

In FY16, FDAs Center for Food Safety and Applied Nutrition (CFSAN) provided ODSP $4.6 million, the agency disclosed to the Senate Committee on Appropriations. Michael Felberbaum, an FDA spokesman, said in an email to INSIDER that ODSPs FY17 budget is $6.5 million.

FY16 FDA Dietary Supplement Activities

678 domestic inspections

99 foreign inspections

83 warning letters

6 untitled letters

49 detentions

3 injunctions

Source: FDA FY18 budget request to Congress

Appropriators on Capitol Hill with whom CRN has met believe that an office should be funded appropriately because these are products that we put into our bodies," Greene said. We have to be very concerned with public health."

While FDAs FY18 budget request to Congress doesnt specify a requested funding level for ODSP, CFSAN may have an incentive to boost FY18 funding for dietary supplement activities if it receives such direction from Congress in House and Senate appropriations committee reports.

Nonetheless, Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, cautioned, Technically, FDA doesnt have to follow the report languagejust be prepared to explain what it did or didnt do in response to it. As a practical matter, they are not going to say that they didnt follow Congress direction."

On June 20, FDA Commissioner Scott Gottlieb, M.D., appeared before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.

During the hearing to discuss President Trumps FY18 request and the budget justification for FDA, lawmakers discussed with Gottlieb a range of issues from the opioid epidemic to prescription drugs to regulations impacting premium cigars.

Dietary supplements werent mentioned. On a broader level, lawmakers expressed concerns about FDAs ability to carry out its duties under Trumps proposed budget.

Excluding a proposal to increase user fees and the mandatory funding through the 21st Century Cures Act of 2016, FDAs FY18 budget features a 34 percent cut, according to Sen. Patrick Leahy, a Democrat from Vermont.

The cuts include $119 million from monitoring food safety and a $55 million reduction in medical product safety," Leahy said in a statement. In my many years in the Senate, I have heard repeatedly that the FDA needs more, not less, resources to adequately fulfill the agencys mission."

In response to a question from Sen. Jon Tester (D-Montana) regarding expedited review of generic drugs under Trumps budget proposal, Gottlieb conceded, These are challenging budgetary times, and were going to have to figure out ways to do more with less."

While Greene of CRN acknowledged the budgetary constraints under the Trump administration, he described a $5 million increase in ODSPs budget as a drop in the bucket" relative to FDAs overall budget ($5.1 billion in requested appropriations for FY18).

CRN is seeking additional funds for ODSP to increase dietary supplement inspections and bolster enforcement activities to target companies that violate the law, such as dietary supplement firms that spike products with pharmaceutical ingredients. ODSP has faced criticisms on occasion for moving too slowly against bad actors" in the industry, while the agency has cited limited resources and its focus on safety in prioritizing its work.

Concluded Greene: We are a growing and robust industry, and therefore, we should have an office that matches the industry growth and is able to inspect and enforce all the things that they [FDA officials] need to fully implement the Dietary Supplement Health and Education Act."

The following members of Congress did not respond to requests for comment for this article: Sens. John Hoeven (R-North Dakota) and Jeff Merkley (D-Oregon), the chairman and ranking member of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration; Reps. Robert Aderholt (R-Alabama) and Sanford Bishop (D-Georgia), the chairman and ranking member of the corresponding appropriations subcommittee in the House; and Sen. Dick Durbin (D-Illinois), who has introduced dietary supplement legislation in previous years andcited shortcomings withthe current regulatory framework at FDA.

More:

Trade Group Seeks More Funds for FDA to Police Dietary Supplements - Natural Products INSIDER (blog)

By RALPH ANSAMI

ransami@yourdailyglobe.com

Ironwood - For the second straight year, a Feed the Hungry van arrived Monday to bring 21,000 pounds of food to the Lighthouse Faith Center Church on Ironwood's Ayer Street.

Pastor Tom Rouse said the free food products will be distributed to the needy on the Gogebic Range on Thursday from 5 to 8 p.m.

"Whoever comes, comes," he said of the would-be recipients.

Rouse said from his conversations with area food shelter operators, like the Union Station pantry, the need is as great or greater than ever for the food supplements on the Gogebic Range.

The semi-truck and trailer arrived for unloading on a rainy, cold Monday morning from "Feed the Hungry," of South Bend, Ind., and there were about a dozen volunteers on hand to help out.

Forslund Building Supply of Ironwood offered a forklift for the church to use to remove the large boxes from the truck.

Rouse said some of the food items were to be transported to the companion church in Calumet.

Included in the food items are sausages, oatmeal, apple juice, granola bars and cereal.

The church has been feeding hungry people in Africa for more than a decade. "We've fed 43,000 people in Africa," Rouse said.

The food distribution here is available to anyone in need. They should bring bags or boxes for the food.

The church is at 777 E. Ayer St., near the high school baseball field.

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Lighthouse Church offering free food - Your Daily Globe.com