The Germans are the best-known herbalists in the world, but a new product that could save a nation of 1.3 billion people by turning back the clock is making its debut.
The herbal product, called the Gefilte fish extract, is made from fish but with a blend of plants, according to an FDA notice posted online.
Gefiltte is made by extracting the fishy, oily fish from a gillnet called a kurkurk, a piece of wood used for woodworking, according the FDA.
The fishy oil has a medicinal effect that includes reducing the inflammation caused by cancer and helping the immune system fight infections, according Dr. Jörg Schuster, chief scientific officer at the German company Gefeltz.
He said Gefiledte is a “good alternative” to traditional medicine that has a number of other health benefits, including boosting the immune systems and helping to prevent and treat infections.
In its first week of sales, Gefildt has been sold in Germany for just under $2 per unit.
It’s also available in other European countries, including France, Spain, and the United Kingdom.
In the United States, the drug is being marketed by drugmaker Sanofi-Aventis and is expected to be available in stores in the fall.
Schuster said the fish oil will have about 30 to 40 percent of the anti-inflammatory effects of the Gysin supplement, which is made with plant extracts and can reduce inflammation in the liver.
The supplement contains no synthetic chemicals and is only extracted from fish.
The FDA said GEFilte has no safety or effectiveness data, but it’s not the only fish oil product making the news.
A number of products have been developed for people with Crohn’s disease, such as the Sea to Sky fish oil.
But Schuster and others have criticized the FDA for not requiring a safety evaluation for the supplements.
It also isn’t the first fish oil to have the name “fish.”
The FDA is considering an appeal against a ruling that it has blocked an oral supplement that was developed by a New York-based company, called Cetaphil.
The Fish Oil Association of America, a trade group, filed a petition last year in federal court in California, asking the FDA to let Cetabil go forward.
The group said the FDA failed to consider whether the product was safe or effective and was ignoring a long-standing and growing body of scientific evidence about fish oils, including an FDA study that found the fish oils are no better than placebo for reducing symptoms of Crohn.
A spokeswoman for the FDA said the agency is reviewing the FDA’s notice and will provide a response by the end of the week.
The company that developed Cetacil said in a statement on Tuesday that it’s disappointed the FDA has blocked it from selling its product.
“The FDA’s decision to halt its FDA-approved product Cetacycline is a disappointing move that is in conflict with the scientific evidence supporting the effectiveness of Cetacline in preventing Crohn disease and its related inflammatory and autoimmune disorders,” the statement said.
The agency has been scrutinizing Cetatacil in recent months, particularly over a study of its anti-inflammatories in Crohn patients, because of a connection to the fish-oil supplement.
The study, conducted in 2013 and 2014, showed that fish oil had no effect on Crohn symptoms or inflammation in Crohns.
In a statement, the FDA acknowledged the Fish Oil and Lifestyle Foundation has been conducting research with Cetawil, and that the Fish oil group is continuing to do research with its product, but said the organization will not be able to share any information with the FDA about the efficacy of the Fish oils in patients with Crohneas.