ABC: Why is skullcap still being adulterated with germander?

22-Feb-2012 - Germander is still being used as a substitute for skullcap in dietary supplements, despite ongoing attempts to raise awareness about the problem, according to a new paper published by the American Botanical Council (ABC).

AHA GRAS attack reaction: Why self-affirmed GRAS is not ‘GRAS lite’

21-Feb-2012 - Experts in helping firms navigate the GRAS (generally recognized as safe) process say the American Heart Association (AHA) made some valid points in its recent attack on GRAS, but argue the system is actually working pretty well.

Guest article

2011 FDA Warning Letter Review: The Rise of GMPs

10-Feb-2012 - GMP violations dominated dietary supplement warning letters issued by the Food and Drug Administration in 2011, from failure to establish product specifications to poor record keeping, reveal FDA legal specialists Ivan Wasserman and La Toya Sutton.

ABC paper promises to dispel ‘myth’ of unregulated supplements

07-Feb-2012 - A new paper published by the American Botanical Council (ABC) attempts to dispel the ‘puzzling’ and pervasive ‘myth’ that the US dietary supplements trade is unregulated.

cGMP compliance, time bombs and the ‘ten-ton elephant in the room’

24-Jan-2012 - An analysis of recent Food and Drug Administration (FDA) warning letters has exposed several ‘ten ton elephants in the room’ and ‘time bombs waiting to go off’ when it comes to cGMP (current good manufacturing practice) compliance, according to one leading testing lab.

Idaho judge fines firms selling ‘synthetic steroids masquerading as dietary supplements’

23-Jan-2012 - Two firms found guilty of selling muscle building supplements laced with unapproved drugs have been fined by a federal court in Idaho.

AHP releases monograph for 'one of the most widely adulterated herbs on the market'

12-Jan-2012 - A monograph for American Ginseng – claimed to be one of the most widely adulterated herbs on the market - has been released by the American Herbal Pharmacopoeia (AHP).

Be on your guard for ‘bath salt’ stimulants in supplements, warns expert

09-Jan-2012 - Dangerous stimulants in so-called ‘bath salts’ and plant food could make their way into the supplements trade this year if firms do not maintain their vigilance, according to one expert in the analytical testing field.

FDA warning letters: Social media, website claims & GMP violations

03-Jan-2012 - The FDA published a handful of warning letters in late December, with cGMP violations and claims on websites and social media sites continuing to catch the FDA’s eye.

FDA will 'consider whether regulatory action is warranted on DMAA'

22-Dec-2011 - The Food and Drug Administration (FDA) has weighed into the debate over the stimulant DMAA (1,3-Dimethylamylamine, also known as methylhexaneamine or MHA), which has garnered more bad press in recent weeks.

The agony and the ecstasy: A year in the life of the trade association…

20-Dec-2011 - Not surprisingly, the FDA's draft guidance on new dietary ingredients (NDIs) is top of the list for most trade associations when asked what is keeping them awake at night as we head into 2012, but it is not the only thing causing sleepless nights.

Infiniti Marketing Group: ‘We are NOT the firm targeted by FDA in ephedrine seizure’

08-Dec-2011 - A California-based company with the same name as a firm targeted by the Food and Drug Administration (FDA) in a crackdown on adrenaline-like stimulants says it has been inundated with calls from confused customers, although it has nothing to do with the FDA enforcement action.

US Marshals seize ephedrine-containing raw materials for supplements

07-Dec-2011 - The FDA claims US Marshals have seized $70,000 worth of raw materials for dietary supplements containing ephedrine alkaloids, as enforcement action in the dietary supplement industry continues.

Syntec hopes for 'swift resolution' with FDA post supplement seizure

07-Dec-2011 - Syntec Inc (Syntec Nutraceuticals) says it is “fully co-operating” with the Food & Drug Administration (FDA) after supplements made at its facility in Wisconsin were seized following allegations of serious cGMP violations and unauthorized disease claims.

Syntec supplements seized over unauthorized disease claims and serious cGMP violations

05-Dec-2011 - The Food and Drug Administration (FDA) says it had no choice but to seize supplements manufactured by Syntec Inc (Syntec Nutraceuticals) after the firm committed serious cGMP violations and ignored warning letters accusing it of making unauthorized disease claims.

NJ supplement companies hit with $1 million fines, owners get 'stiff' prison sentence

01-Dec-2011 - The owner of two New Jersey-based dietary supplement companies guilty of criminal contempt of court relating to GMP violations has been sentenced to prison for 40 months.

GMP inspections show ‘consistent fundamental failures’: Israelsen, UNPA

29-Nov-2011 - The ‘consistent fundamental failures’ of companies in the dietary ingredients and supplement segment for current good manufacturing practices (GMPs) is a ‘topic of disappointment’, says Loren Israelsen.

FDA files permanent injunction against supplement manufacturer

25-Nov-2011 - The US Food and Drug Administration has filed for a permanent injunction against a Pennsylvania dietary supplement manufacturer as the agency turns the GMP compliance screw.

Warning Letters continue as FDA maintains cGMP vigilance

23-Nov-2011 - The US Food and Drug Administration (FDA) has issued two warning letters in November for alleged dietary supplement cGMP violations, as the agency maintains its vigilance.

FDA on warning letters: ‘We are going to do more than just hand out paper’

24-Oct-2011 - The dietary supplements industry should keep an eye on GMP compliance, and not be distracted by discussions over NDIs, because enforcement may move beyond handing out paper if warning letters are ignored, said FDA’s Dr Daniel Fabricant.

Dispatches from SupplySide West

Imminent ‘seed event’ set to expose dry labbing issues?

19-Oct-2011 - The industry may be on the verge of facing up to potential ‘dry labbing’ issues, which could bring the issue to the forefront and ‘hopefully get this problem fixed’, says ChromaDex’s Frank Jaksch.

EuroPharma to launch probe into synthetic vs natural curcumin

07-Sep-2011 - EuroPharma is planning to launch a probe into commercially available curcumin supplements to establish whether products purporting to contain exclusively natural extracts in fact contain cheaper, synthetic raw materials.

ChromaDex seals African botanical standards deal

06-Sep-2011 - ChromaDex has signed a deal with the Association for African Medicinal Plants Standards (AAMPS) to sell and market its botanical standards and the African Herbal Pharmacopoeia.

USDA expresses skullcap supplement concerns with new analytical method

30-Aug-2011 - Scientists with the US Department of Agriculture (USDA) have developed a ‘simple, fast, and easy’ method to test for adulterants in skullcap herbal formulations, a timely development given potential short-comings with formulations currently on the market.