Goodgut prebiotics gain mass retail distribution
PALO ALTO, Calif. — Greenteaspoon, the team behind Goodgut, on Thursday announced that its clinically-proven line of prebiotic supplements is now available at leading retailers nationwide.
Goodgut products, which work to help stop "leaky gut" and promote digestive health, have been offered through the company's website and on Amazon.com for the past year. Now, customers have the option to pick up Goodgut prebiotics from their local Walgreens, CVS, Vitamin Shoppe or Meijer stores.
"On behalf of the Goodgut science and R&D team, we're thrilled our customers now have the option to shop for our products at leading national chain outlets within their own neighborhoods," stated Robert Wotring, CEO of Greenteaspoon. "We believe that the Goodgut product line has the potential to fundamentally transform people's digestive, as well overall, health and well-being – and we are extremely excited that leading drugstore chains have embraced our breakthrough offering," he said. "The fact that Goodgut is now accessible to individuals via the mass consumer marketplace speaks to the retail segment's growing support for what we believe is a truly evolutionary addition … to the fast-growing prebiotic/probiotic space."
The brand markets multiple formulas designed to help a range of individuals based on their specific digestive profiles and overall gut health needs.
Goodgut Rescue provides rapid help for the sudden onset symptoms of diarrhea, upset stomach, gas and bloating; Goodgut Balance alleviates digestive distress and is designed to help balance daily health; and Goodgut Boost helps to strengthen the immune system.
CHPA advocates for modernized OTC Monograph system
WASHINGTON — The OTC Monograph system that regulates over-the-counter medicines is more than four decades old and in need of modernization, according to Consumer Healthcare Products Association president and CEO, Scott Melville who testified earlier this week in strong support of OTC Monograph reform before the House Energy and Commerce Committee, Subcommittee on Health.
“CHPA member companies produce the vast majority of OTC medicines in our country and provide millions of Americans with safe, effective and affordable therapies to treat and prevent many common ailments and conditions,” Melville said. “The availability of self-care treatment options saves money, reduces burdens on the healthcare system, and keeps consumers active and productive.”
Citing the importance of OTC medicines to consumers and our nation’s healthcare system, Melville emphasized that it is essential for the OTC regulatory structure to promote efficiency, transparency and innovation. To ensure the U.S. Food and Drug Administration is adequately funded and resourced to accomplish this important work, the subcommittee is considering a draft of OTC Monograph reform legislation.
CHPA strongly supports the OTC Monograph system as a balanced framework for regulating OTC medicines containing ingredients with a proven history of safe use. And, as emphasized in the Congressional hearing, CHPA, health professionals and manufacturers in the OTC marketplace support modernization.
“The legislation we are discussing today is incredibly important and, if enacted, will impact the health of nearly every American for decades to come,” Melville said. “It’s the product of months – and even years – of consideration and compromise between many stakeholders,” he said. “We look forward to continuing to work with members of this committee to finalize the text and support its introduction and consideration by the Congress.”
CRN challenges Amarin Pharma complaint against 18 omega-3 manufacturers
WASHINGTON — The Council for Responsible Nutrition on Thursday strongly urged the United States International Trade Commission to reject a complaint filed by Amarin Pharma against 18 manufacturers of concentrated EPA omega-3 fish oil.
In two separate filings with the ITC, CRN argued the complaint is “financially motivated” to expand Amarin’s near monopoly over a subset of omega-3 products and would “dramatically affect consumers’ access by making it more difficult and expensive, if not impossible, to obtain the health benefits associated with these products.”
Additionally, the Amarin complaint suffers from significant legal deficiencies that should “preclude institution of an investigation under Section 337 and the Commission Rules.”
“This appears to be a case of a company seeking a market monopoly that would deprive both legitimate manufacturers of selling legal fish oil supplements and consumers of having access to products that benefit their health and well-being,” stated Steve Mister, president and CEO CRN.
In asking the ITC to make a legal determination whether the products in question “are ‘dietary supplements’ within the meaning of [Food, Drug & Cosmetic Act (FDCA)] Section 321,” CRN says Amarin has crossed a legal boundary. “Amarin is inappropriately seeking to bypass the U.S. Food and Drug Administration’s rightful authority to make this determination by filing its complaint with the ITC,” said Rend Al-Mondhiry, associate general counsel, CRN. “Contrary to Amarin’s assertions, FDA has exclusive authority to make this determination.”
CRN submitted two separate filings in the case: the first arguing that Amarin’s requested prohibition on the importation or sale of concentrated omega-3 supplements runs counter to public interest, and the second urging the ITC to reject the complaint because it essentially asks the ITC to second-guess how the FDA would answer the question of these products’ legal status under the FDCA.
The first filing focuses on public interest implications and argues that Amarin’s request would limit millions of Americans’ ability to obtain concentrated omega-3 supplements without a prescription for the preventive benefits those supplements provide. Additionally, the request would further convert a highly competitive market to an Amarin monopoly.
In the second filing, which focuses on legal standing, CRN refutes Amarin’s claims that concentrated omega-3 supplements have not been recognized as dietary supplements by the FDA. Amarin cannot ask the ITC to find a violation of the FDCA without pointing to specific cases or documents where FDA has expressly adjudicated the status of these supplements; therefore, CRN states the Commission has ample ground to reject Amarin’s complaint and determine not to institute an investigation.
CRN is working in consultation with the law firm Adduci, Mastriani & Schaumberg, specialists in international trade law.