Leisure, Lifestyle & Wellness
FDA Warns Companies about Dangers of Stimulants in Supplements
Eight products found to have BMPEA and 17 products contain DMBA, both amphetamine-like stimulants
 
Just a few weeks after the FDA said it didn’t think an amphetamine-like stimulant known as BMPEA found in weight-loss products was a safety concern, it issued warnings to five companies listing it as an ingredient on their supplement products based on labeling issues. 
 
The warnings come after Harvard doctor Pieter Cohen lambasted the FDA for not taking more aggressive action against supplements that contain BMPEA, which hasn’t been proven safe for human consumption and has been found in Acacia rigidula weight-loss, body-building and brain function products.
 
Acacia rigidula is a perennial shrub found in Texas and Mexico. A study co-authored by Cohen and published in the journal Drug Testing and Analysis found that 11 supplements out of 21 tested that are labeled as having Acacia rigidula, contained BMPEA. After the study was published, three Democratic U.S. Senators, Charles Schumer, Richard Blumenthal and Richard Durbin, also urged the FDA to take action.
 
Cohen said companies were using the stimulant in their products as replacements for other ingredients, such ephedra and DMAA, and cloaking it as a natural extract of Acacia rigidula. In 2013, the FDA found BMPEA in nine out of 21 Acacia rigidula workout and diet supplements but never took any further action. The agency said it didn’t consider the stimulant a safety concern.
 
In its recent warning letters, however, the FDA said BMPEA does not meet the statutory definition of a dietary ingredient and thus any products with the ingredient are misbranded as dietary supplements. Additionally, it said BMPEA is “not approved as a food additive or prior sanctioned for use in dietary supplements” and that the agency has not concluded that it is safe for use in food.
 
FDA spokesman Jennifer Dooren said the warnings were based on misleading labeling issues.
 
“We didn’t reverse our previous statement on safety,” she said. ” The FDA took action against products containing BMPEA because it is not a new dietary ingredient. Declaring BMPEA as a dietary ingredient in product labeling causes products marketed as dietary supplements to be misbranded in that the labeling is false or misleading.”
 
The warnings related to a total of eight products, including two where companies identified the source of BMPEA as the botanical Acacia rigidula. In the letters to the companies, the FDA said that its 2013 study established that BMPEA is not a constituent or extract of Acacia rigidula.
 
The warning letters went to:
Hi-Tech Pharmaceuticals for Fastin-XR, Fastin Rapid Release and Lipodrene Extended Release. 
Tribravus Enterprises for Conquer. 
Train Naked Labs for Critical FX and Sudden Impact. 
Better Body Sports for Phoenix Extreme. 
Human Evolution Supplements for Core Burner Watermelon.
 
Following the warning letter, Hi-Tech filed a lawsuit against Cohen and the other co-authors of the Harvard study, alleging they published “false and malicious statements about the safety and efficacy of dietary supplements containing Acacia rigidula manufactured by High-Tech and others, with the intent to influence the FDA.” The suit contends that BMPEA is a naturally occurring compound of Acacia rigidula.
 
The FDA Wednesday also issued warning letters to 14 companies for 17 products containing another stimulant, DMBA. DMBA is related to the stimulant 1,3-dimethylamylamine (DMAA), which was banned by the FDA.
 
Cohen said the FDA needs to take additional actions regarding companies whose products contain these stimulants. He noted that the FDA only went after companies whose products listed the stimulants as ingredients, but not the ones where the stimulants have been found but aren’t listed on the labels. Last year, a study also co-authored by Cohen found DMBA in 12 of 14 supplements tested.
 
“BMPEA and DMBA are both synthetic, untested stimulants masquerading as natural products that should never have been in supplements in the first place,” Cohen said. “A lot of work still needs to be done.”
 
In response to a question about whether the FDA plans further action against products containing the stimulants, the FDA’s spokeswoman Dooren said, “I cannot speculate on future enforcement action regarding other products.”
 
For more of TINA.org’s coverage of dietary supplements click here.
This story was updated on 5/1/2015. 
 

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Gadkari denies wrongdoing, Rajya Sabha disrupted

The BJP leader denied any wrongdoing by the Purti Group or by him in financial dealings

 

The Rajya Sabha was repeatedly disrupted on Monday as opposition demanded union Road Transport Minister Nitin Gadkari's resignation over alleged corruption.
 
The BJP leader denied any wrongdoing by the Purti Group or by him in financial dealings.
 
The upper house saw at least eight adjournments before being adjourned for the day around 4 p.m.
 
Before the last adjournment, the agitated opposition members refused to allow Leader of House Arun Jaitley to make a statement on the issue.
 
Amid slogans demanding Gadkari's resignation, the minister said the report was "deliberately being misinterpreted for political reasons".
 
"There is no scam or irregularity... Purti has repaid all loans. There are no allegations against me," Gadkari said amid sloganeering by Congress members.
 
Gadkari's reaction came after the Congress demanded his resignation over a Comptroller and Auditor General report that has named him as one of the "promoters and/or directors" of Purti Sakhar Karkhana Ltd. that was sanctioned a loan of Rs.84.12 crore by the Indian Renewable Energy Development Agency (IREDA) in violation of guidelines.
 
"My respectful submission before this august house is that let us follow the established procedure in the matter of CAG reports and if any wrongdoing is established by the PAC (parliamentary affairs committee), which will be discussing the CAG report in due course of time, the law should take its own course," Gadkari said.
 
"The CAG has nowhere named me as a wrongdoer nor there is any adverse comment against me. There is neither any indictment nor any charge of corruption or misappropriation against me of the PSKL (Purti Sakhar Karkhana Ltd.)," he said.
 
As Gadkari finished his statement, the Congress members kept protesting, forcing Deputy Chairman P.J. Kurien to adjourn the house for 10 minutes.
 
When the house met again, Leader of Opposition Ghulam Nabi Azad said they were not satisfied with the minister's response. Azad said the loan was taken for a different purpose but was used for generating thermal power.
 
"You are getting a loan for a project and you are using it for something else. Whether it was returned or not is a different issue," said Azad. After this, Congress members once again started raising slogans demanding Gadkari's resignation.
 
Minister of State for Parliamentary Affairs Mukhtar Abbas Naqvi said: "We are not making him resign to satisfy you... There is no allegation of corruption."
 
Amid the din, Kurien adjourned the house again till 12 p.m.
 
The question hour saw similar scenes, and after two brief adjournments of 15 minutes each, Chairman M. Hamid Ansari adjourned the house till 1 p.m.
 
At 1 p.m. the house passed an amended version of Land Boundary Agreement bill, before adjourning for lunch.
 
However, when the house reassembled at 2 p.m., Congress members were once again on their foot. The house was adjourned till 2.30 p.m., then till 3.00 p.m. and after that till 4 p.m..
 
At 4 p.m., Leader of the House Arun Jaitley tried to make a statement on the issue. However, he was not allowed to speak by shouting opposition members.
 
"What they are saying has no basis," Parliamentary Affairs Minister M. Venkaiah Naidu said.
 
As the protests continued, the house was adjourned for the day.

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E-auction of imported gas for idle power plants from Tuesday

Imported RLNG will be made available at a reduced price under the scheme

 

E-auction for allocation of imported regasified liquefied natural gas (RLNG) under the power ministry's scheme for gas-based power plants is set to begin on Tuesday, the government announced.
 
"E-auction process for Power System Development Fund (PSDF) support under the Scheme for Utilization of the Stranded Gas-based Generation Capacity will start Tuesday, 12th May at 11 a.m.," the power ministry said in a statement here on Monday.
 
On May 12, the reverse e-auction will be held for stranded gas-based power plants and on May 13, the reverse e-auction for plants receiving some domestic gas and running at sub-optimal levels, it added.
 
Imported RLNG will be made available at a reduced price under the scheme. Besides, the reverse bidding process will determine a tariff subsidy, which will be released to power plants through the PSDF.
 
The Cabinet Committee on Economic Affairs (CCEA) in March allowed gas imports by way of e-auctions for 31 gas-based power units, with a capacity of 14,000 MW, lying idle for lack of feed stock.
 
"The additional generation would help light up many unconnected households in the country, besides benefiting the public at large, including farmers and poorer sections of the society who have limited access to electricity," the CCEA communique had said.
 
"This decision will also help improve grid stability and safety, as gas-based plants are ideal for being used as spinning reserve, and for meeting peaking power requirements, as they can be started and shut down at very short notice," it said.
 
Power and Coal Minister Piyush Goyal told reporters that GAIL and GSPL (Gujarat State Petronet Ltd) will be permitted to import gas by purchasing on a spot basis from the international market and supply to companies, who can bid for this gas depending on their requirements.
 
"The bidding process will be reverse bidding, where companies can bid for this gas for up to 30 percent of their plant load factor (PLF)," he added.
 
Explaining the reverse bidding to keep down power tariffs, Goyal said: "We could start the bidding at around Rs.5.50 a unit and then see if we can go lower depending on the international gas prices."
 
The need for this intervention has arisen because discovery of natural gas in the Krishna-Godavari basin, notably from the blocks awarded to Reliance Industries, had raised expectation of considerable increase in the availability of domestic gas in the country.
 
Accordingly, a large number of gas-based plants were set up by developers, some with firm allocation and others with expected allocation. But the supply of domestic gas to them started declining since 2012 and stopped from March 2013.
 
Since then, these plants have either stopped operating or being under-utilized.
 
Out of 24,150 MW gas-grid-connected power generation capacity in the country, 14,305 MW of capacity has currently no supply of domestic gas and may be considered as stranded.
 
"This represents an investment of over Rs.60,000 crore which is at the threshold of becoming non-performing assets. The balance capacity of 9,845 MW involving an investment of over Rs.40,000 crore is also working at a sub-optimal level," CCEA said.
 
Rating agency CRISIL said in a statement on Monday that the success of the scheme will hinge on the ability of power plants that are allocated the imported RLNG to find buyers for their electricity.
 
"That's because, as per the scheme, the net sale price of electricity to distribution companies (discoms) has been fixed in the Rs.4.7 to Rs.5.5 per unit band, well above current average prices in a market plagued by low demand," it said.
 
"It is also higher than the average Rs.3.5 to Rs.4.5 per unit that discoms paid last fiscal," CRISIL added.
 

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