NY AG Investigation Goes after “Misbranded” Devil’s Claw Supplements Now

« After what appeared like a quiet couple of months, New York Attorney General (NY AG) Eric Schneiderman’s dietary supplements investigation has resurfaced—this time issuing cease-and-desist letters to makers of devil’s claw supplements sold in the state of New York.
On September 9, AG Schneiderman’s office sent cease-and-desist letters to 13 devil’s claw supplement manufacturers, including NBTY, Now Foods, Thorne Research, Nutraceutical International Corp., and Nature’s Sunshine Products, alleging that their products contain a plant species that is not in fact the more-expensive devil’s claw species Harpagophytum procumbens. Schneiderman ordered the companies to recall the products and to compensate consumers who purchased them.

To test the devil’s claw products, the NY AG’s office once again employed DNA barcode testing, a method his office has relied on throughout its investigation of the herbal supplements industry, which began in February when his office ordered numerous herbal supplements, including ginseng, Echinacea, and St. John’s wort, off retail shelves. The dietary supplements industry has heavily criticized the use of DNA testing on finished herbal products, explaining that DNA may no longer be intact in finished herbal products to allow for accurate testing.
In its press release announcing the devil’s claw probe, the NY AG’s office says that DNA testing performed by the New York Botanical Garden found that the supplements in question contained a “cheaper related species that is considered less desirable”—namely, related devil’s claw species Harpagophytum zeyheri, “which contains some—but not all—of the same chemicals” as Harpagophytum procumbens.

Of the 16 supplements that the New York Botanical Garden was able to detect DNA in, tests allegedly found that all contained Harpagophytum zeyheri, either alone (81 %) or in mixture with Harpagophytum procumbens (19 %).
But in an American Botanical Council (ABC; Austin, TX) press release, medicinal plant expert Thomas Brendler, editor of the African Herbal Pharmacopeia, says that Harpagophytum procumbens and Harpagophytum zeyheri are equally effective, despite their different chemical makeup.
“Both species of devil’s claw have a similar chemical profile,” Brendler is quoted as saying. “While both species differ marginally in shape and chemical composition, both are considered equally effective.” And, the ABC press release points out, some government pharmacopeias consider the two species interchangeable in terms of anti-inflammatory properties and benefits for osteoarthritis, and that it is not uncommon to find devil’s claw extract in the global market containing both devil’s claw species. (In Canada and Europe, devil’s claw is sold as an arthritis treatment, according to an ABC HerbClip monograph on devil’s claw.)
“According to various government-recognized medicine evaluation bodies and pharmacopeias, the two species of devil’s claw are considered interchangeable for the purpose of their use for their medicinal actions,” the ABC press release states. “These organizations include the European Medicines Agency, the European Pharmacopoeia, and the unofficial ESCOP (European Scientific Cooperative for Phytotherapy), a pan-European consortium of medicinal plant experts. Also listing both species as interchangeable is the proposed monograph ‘Harpagophytum species root’ in the United States Pharmacopeia’s Herbal Medicines Compendium.”

Mark Blumenthal, founder and executive director of ABC, said in the press release that while his group appreciates the NY AG’s interest in herbal supplement quality, “splitting the devil’s claw genus in the very narrow way that they have done in this investigation is akin to splitting hairs—it has no real meaning or value to anyone, particularly the herb consumer.”
“This may be a hair-splitting botanical distinction,” noted Blumenthal in the press release, “but it certainly is not a legal or regulatory one, especially since authoritative sources recognize both species as being ‘devil’s claw.’”
Blumenthal also points out that ABC data show devil’s claw to be a relatively low-selling herb in the United States, with total sales in the country ranging from $ 250,000–$ 500,000.

One Company Settles
AG Schneiderman’s office announced that it has so far reached agreement with one devil’s claw supplement manufacturer, Nature’s Way, who, unlike the other manufacturers, did label its product as containing a combination of Harpagophytum zeyheri and Harpagophytum procumbens. According to the AG’s press release, the company has agreed not only to issue refunds to customers but also to employ DNA barcode testing in its operations in order to ensure that devil’s claw products do not contain Harpagophytum zeyheri.
This is the second company to settle with the NY AG’s office in the course of his investigation of the supplements industry. In March, retailer GNC agreed to employ DNA testing at its facilities—a move criticized by many industry members.

Supplements Probe Persists
After this latest move, it appears that AG Schneiderman will not let up on his investigation of the herbal supplements industry. In June, AG Schneiderman and a collation of state attorneys general asked FDA to enact stricter dietary supplement regulations and asked Congress to do the same in April.
In his office’s press release on the devil’s claw investigation, AG Schneiderman said, “When a scientific study tests numerous herbal supplements manufactured by more than a dozen companies and finds the wrong plant in just about every one, it raises more troubling questions about whether people who buy dietary supplements are getting what they pay for. This is yet another sign that weaknesses in the supplements industry’s approach to quality control are having real-world consequences for consumers. The manufacturers receiving letters from my office should follow the lead of Nature’s Way and address these gaps immediately.”

Industry reactions to this latest NY AG probe are largely critical.
Dan Fabricant, PhD, executive director and CEO of the Natural Products Association (Washington, DC), stated: “More than six months have passed since the Attorney General first began this inquiry and two critical issues remain. First, he has yet to make public or subject to peer review the questionable ‘science’ or ‘research’ on which this action is based, and second, he has not pursued prosecutorial actions in either case. We encourage the U.S. Food and Drug Administration and other public health interests to ask the Attorney General to release his findings immediately so they can do the most good for consumer protection in the quickest fashion possible.”

Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), issued this statement: “Supply chain integrity is of the utmost importance to the dietary supplement industry. There are multiple ways to qualify the supply chain, to identify ingredients, and to detect adulterants in products. The companies involved should be permitted to defend their methods of ingredient testing and to justify their use of particular species of botanicals before being declared to be misbranded or adulterated by the New York Attorney General. The federal law for dietary supplements requires that what’s in the bottle is on the label. Proper identification of ingredients is a requirement of federal law and we expect all companies to stand behind the quality of their products. As we have seen before, investigations by the New York Attorney General’s office are rarely as clear-cut as they might seem.”

Article by Jennifer Grebow

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ABC- Devil’s Claw Position

American Botanical Council: New York Attorney General’s Investigation on Devil’s Claw Ignores Expert Evaluations and Provides No Benefit to the Public
Herbal science organization says that NY AG focus is too narrow and is “splitting hairs”
The nonprofit American Botanical Council (ABC) says that the New York Attorney General’s (NY AG’s) investigation on the herb devil’s claw has reached an incorrect conclusion based on its too-narrow interpretation of botanical classifications.
Today the NY AG sent cease-and-desist letters to 13 companies that sell devil’s claw herbal dietary supplements informing them that their products containing devil’s claw material were tested at the New York Botanical Garden using DNA technology. The results showed that the devil’s claw was a different botanical species than what was labeled, and what the NY AG termed a “less desirable” species of the herb.
In botanical classification and nomenclature, devil’s claw is usually known scientifically by its Latin name, Harpagophytum procumbens, where Harpagophytum is the genus of the plant and procumbens refers to the species of the plant. The DNA-barcoding tests commissioned by the NY AG showed that some herbal supplements actually contain Harpagophytum zeyheri, a slightly different form of devil’s claw, i.e., a different, but very closely related species. In effect, they are like two siblings.

“Both species of devil’s claw have a similar chemical profile,” said Thomas Brendler, a medicinal plant expert and editor of the African Herbal Pharmacopeia, a compilation of technical information of various African medicinal plants, including their botany, growing conditions, range of habitat, chemistry, and traditional and modern medicinal activities and uses.
“While both species differ marginally in shape and chemical composition, both are considered equally effective,” he added.
According to various government-recognized medicine evaluation bodies and pharmacopeias, the two species of devil’s claw are considered interchangeable for the purpose of their use for their medicinal actions. These organizations include the European Medicines Agency, the European Pharmacopoeia, and the unofficial ESCOP (European Scientific Cooperative for Phytotherapy), a pan-European consortium of medicinal plant experts. Also listing both species as interchangeable is the proposed monograph “Harpagophytum species root” in the United States Pharmacopeia’s Herbal Medicines Compendium.
Brendler added that many, possibly most, devil’s claw extracts in the world market are based on mixtures of the two species, as are devil’s claw herbal teas and dried powdered root materials used in supplements and other products. Both species of devil’s claw have been in the market in the United States since the 1980s, he noted.
“We sincerely appreciate Attorney General Schneiderman’s interest in the quality of herbal materials sold in dietary supplements and his apparent desire to help consumers maintain access to high-quality, safe, and effective herbal products,” said Mark Blumenthal, founder and executive director of ABC.
“We here at ABC have a similar mission, as evidenced by our long-time efforts in the ABC-AHP-NCNPR Botanical Adulterants Program in which we have been working on educating industry and all relevant stakeholders about quality issues in the global herbal market,” he continued. “However, splitting the devil’s claw genus in the very narrow way that they have done in this investigation is akin to splitting hairs — it has no real meaning or value to anyone, particularly the herb consumer.”
“This may be a hair-splitting botanical distinction,” noted Blumenthal, “but it certainly is not a legal or regulatory one, especially since authoritative sources recognize both species as being ‘devil’s claw.’”
Blumenthal added that, according to data ABC used for its annual herb market report, devil’s claw is a relatively low-selling herb in the United States. In 2014, devil’s claw ranked 162nd in sales in the US mainstream retail market and 150th in the natural and health foods channel. Total estimated sales of devil’s claw dietary supplements in the United States range from approximately $ 250,000 to up to $500,000.

About Devil’s Claw
Devil’s claw, the vernacular name for the two species Harpagophytum procumbens and H. zeyheri, occurs in the desert regions of southern Africa (Namibia, Botswana, and South Africa). Its bitter root has historically been used to treat a wide range of ailments and, prominently, as an anti-inflammatory and digestive. Major clinical uses in modern phytotherapy (herbal medicine) focus on its anti-inflammatory effects in the treatment of joint diseases and back pain. The suggested mechanism of action is through COX-2 inhibition. Some 20 human clinical trials conducted over the last 30 years have confirmed its safety and efficacy in the treatment and alleviation of degenerative joint disease, osteoarthritis, and lower back pain. »


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Compound That Makes Pepper Hot Could Help Kill Cancer Cells

« Researchers figured out how capsaicin kills cancer cells, which may lead to ways of using it in treatment.

A previous study showed that in order to achieve the cancer-killing effects of capsaicin seen in mice, a 200-pound man would have to eat three to eight habenero peppers three times a week.
The compound in chili peppers that makes them hot, capsaicin, has been known to kill prostate cancer cells for about a decade. Researchers have moved closer to a way of using the molecule in cancer treatment by figuring out how it works, they report in a new study.
Capsaicin is already employed medically in pain relief creams, such as Capzasin and Theragen, used for arthritis, backaches and strains. A recent study in China found it can lower the risk of death from cancer, heart and respiratory diseases.
In 2006, a study found that capsaicin can cause prostate cancer cells in mice to die while leaving healthy cells alone. It required, however, giving the mice a dose of the molecule equivalent to a 200-pound-man eating three to eight habanero peppers three times a week.
Researchers at the Indian Institute of Technology Madras found in a new study, published in The Journal of Physical Chemistry, that the molecule binds to the surface of cancer cells and affects the membrane that surrounds and protects it.
By detecting how the molecule interacts with cell membranes, they hope to find better ways of delivering it when attempting to kill cancer cells.
« The study showed that capsaicin lodges in the membranes near the surface, » the researchers said in a press release. « Add enough of it, and the capsaicin essentially causes the membranes to come apart. With additional research, this insight could help lead to novel tools against cancer or other conditions. »

Article by Stephen Feller

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Plant Used In Traditional Mayan Medicine Holds Potential Leishmaniasis Treatment

« Drug Discovery: Researchers synthesize a natural product with activity against visceral leishmaniasis
Researchers synthesized a natural product, pentalinonsterol, that protects mice from the parasite that causes visceral leishmaniasis.
A compound isolated from a plant used in Mayan traditional medicine could be a new drug candidate for the parasitic disease visceral leishmaniasis (ACS Infect. Dis. 2015, DOI: 10.1021/acsinfecdis.5b00081). Spread by sand flies, the disease infects about 300,000 people each year, mainly in tropical regions, and can be deadly if untreated.

Current leishmaniasis drugs, however, have serious drawbacks. Many have toxic side effects, and most must be injected and require long treatment courses. Moreover, the protozoa that cause the disease, Leishmania donovani, have become resistant to some of these drugs in many parts of the world. So researchers such as Abhay R. Satoskar at Ohio State University have been pursuing alternatives.
About eight years ago, Satoskar learned from collaborators in Mexico that traditional Mayan healers in the state of Campeche used a poultice made from the roots of the plant pentalinon to treat cutaneous leishmaniasis. This nonfatal form of the disease, caused by a similar parasite, leads to skin sores. Satoskar says he was initially skeptical, but after visiting the area, he thought, “This seems to be working, whatever it is.” He and his team decided to test the compounds in the plant roots for activity against the parasite that causes visceral leishmaniasis, which targets the spleen, liver, and bone marrow.
They initially tested more than 20 compounds and discovered a novel sterol, pentalinonsterol, with strong activity against the parasites (Phytochemistry 2012, DOI: 10.1016/j.phytochem.2012.06.012). But to produce enough of the compound to evaluate it as a potential drug candidate, they needed to find a way to synthesize it.
In the current study, the researchers synthesized the compound in five steps from pregnenolone, an inexpensive cholesterol. At concentrations of at least 50 µg/ml, the synthetic pentalinonsterol killed a significant portion of leishmaniasis parasites in cell culture. In a separate experiment, the researchers found that the compound decreased the total lipid content of the parasites, indicating that it may work by damaging the protozoa’s cell membrane.
To test pentalinonsterol’s effectiveness in mice, the researchers first encapsulated it within liposomes. Liposomes protect the hydrophobic compound from degradation in the body and “target it directly to the areas where the parasite is living,” says Satoskar, because macrophages in the organs infected by the disease gobble up liposomes as they would other foreign particles. When the researchers injected L. donovani-infected mice with this treatment, parasite levels in the spleen, liver, and bone marrow fell by 83 %, 64 %, and 57 %, respectively, compared with a control treatment of empty liposomes.
The compound was well tolerated by mice, and also activated their immune systems by inducing a T-cell response that was twice as strong as in mice treated with the control. This allows the host to combat the infection, says Elizabeth R. Sharlow of the University of Virginia, a pharmacologist focused on infectious diseases who was not involved in the research.
Sharlow calls the work an “elegant translational study” that integrates novel chemistry, traditional medicine, and natural products to address a pressing clinical need. “Pentalinonsterol could represent the next generation of small-molecule-mediated immunotherapy for visceral leishmaniasis,” she says.
Next, says Satoskar, the researchers are working to develop an oral formulation of the compound and identify its molecular target. »

Article by Deirdre Lockwood

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A Chemist Educates People on the Importance of Organic Cosmetics

« Nearly seven years ago Kasia Cummings founded Buffalo Gal Cosmetics when her daughter began getting rashes on her hands. For her healthy cosmetics are just as important as healthy food “If you’re putting something into your mouth and you’re so concerned whether it’s this that or the other thing, but you’re putting all these chemicals when you’re washing your body, you aren’t doing yourself a service.”
Cummings graduated from University at Buffalo with a degree in medicinal chemistry. She worked in the field in labs for about four years. A year and half ago, Cummings dedicated all of her working hours to her brand Buffalo Gal Cosmetics, time that she says is about 50 percent creative, 50 percent scientific. For Cummings, “scientific” means using traditional method and writing a formula, which is where her degree comes in handy.


But with cheap bottles of perfumes, lotions and lip balms on the market, Cummings said convincing customers to buy her product becomes less focused on making a sale and more focused on educating consumers on the ingredients and the importance of knowing where your product comes from. Because of the secrecy of mass-market cosmetics on their ingredients, Cummings said she feels obligated to be transparent to her customers. She said she wants people to trust and love her brand and feel safe using it. »


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Nanotechnology for a Competitive Chemical Industry: Risks vs Opportunities

« A public hearing was organised by the European Economic and Social Committee to address the possibilities, opportunities and risks of nanotechnology for one of Europe’s key sectors, the chemical industry

Chemical innovations will continue to play a pivotal role in the future, since they are indispensable to meeting people’s basic needs (such as food, health, clothing, housing, energy, communication and nature). Nanotechnology is a key enabling technology for developing new products. Examples of this include energy-saving lighting technology, new pharmaceutical products (for example, tumour therapies), using surface coatings to conserve resources, and the development of new battery and solar cells.
The European Economic and Social Committee (EESC) through its Consultative Commission for Industrial Changes organised on the 9th of September 2015 a public hearing to address the possibilities, opportunities and risks of this technology for one of Europe’s key sectors, the chemical industry, and to illustrate the innovative potential for consumers, SMEs and large businesses. The event was considered also an opportunity to discuss nanotechnology’s contribution to a sustainable industrial policy, including its economic, social and environmental aspects.
Following an interesting series of presentations, Otto Linher, Deputy Head of the Chemicals Unit of DG GROW (European Commission), provided an overview of the European Legislation on nanomaterials. Attention was focused on horizontal themes such as the definition of nanomaterials, REACH and possible new transparency measures to be introduced in Europe. In line with emerging national initiatives across Europe and in the United States, Europe is evaluating the possibility to introduce a European nano-register; Mr. Linher indicated that an impact assessment has been almost completed and will soon be ready for scrutiny.
Information gap on nanomaterials was presented as a crucial issue to be solved. However, considering that complete scientific knowledge (i.a. risk assessment, workers protection, bioaccumulation, microparticles in air, etc.) will not be available in the short/medium term, the right balance between precautionary principle and risk acceptance must be found in order to not jeopardise innovation. »


Programme of the event : http://www.mychemicalmonitoring.eu/dap/files/programme—hearing-nanotechnologie.doc
Presentations : http://www.eesc.europa.eu/?i=portal.en.events-and-activities-nanotechnology-competitive-industry-presen
Article: http://www.mychemicalmonitoring.eu/news/acb64997-4ebb-46ef-bf22-eec9b477d5af/Nanotechnology_for_a_competitive_chemical_industry_risks_vs_opportunities

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Gattefossé- New Technical Center for Personal Care in India

Gattefossé Inaugurates New Technical Center for Personal Care & more in Mumbai, India
« Subsequently growth in its business activity in India initiated Gattefossé group to expand its presence in the country through the establishment of a technical center of excellence.
This new facility reinforces the activity of its affiliate, Gattefossé India, run by Mr Sunil Bambarkar.

This new office and technical center is officially inaugurated with the distinguished presence of Mr Jacques Moyrand, Gattefossé group Chairman, Mr Ajit Singh, Chairman, AGC Worldwide Associated Capsule Pvt Ltd. and Mr Yves Perrin, The Consul General of France.
The center brings together a FDA certified laboratory for pharmaceutical applications to facilitate the use of API’s in formulations as well as a state-of-the-art personal care laboratory on surface area of 325 m² (3500 sqft).
The staff specialists provide an essential technical interface for customers throughout India and beyond using these tools and apparatus. These new premises aim at facilitating the research and formulation work and consolidating the local assistance to customers.
Olivier Midler, CEO of Gattefossé group describes its vision for the future: “Our growth strategy for the company is based on two main pillars; innovation, by pursuing our significant investments in R&D and product applications, and geographical expansion by developing our business and expertise in new territories. All these efforts to ensure our customers a responsive and adapted service specific to their markets.”

About Gattefossé India
« Gattefossé India is a decade run strategic supplier for cosmetics and pharmaceuticals companies in India. This Gattefossé affiliate is responsible for sales, marketing and technical service support throughout the Indian subcontinent. It sustains a profitable operation, supported by a professional team of business development, technical and customer service as well as administration managers. Gattefossé India extends extensive regulatory, toxicological support, technical and application guidance to the pharmaceutical and personal care customers. »


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