FDA – Methylsyneprhine in food supplements warning letters

This week the US Food and Drug Administration (FDA) issued several warning letters similar to the one below, to food business operators marketing food supplements containing methylsynephrine.
This letter concerns your product XXX which is labeled and/or offered for sale as a dietary supplement. The ingredient list on your product labeling declares methylsynephrine as a dietary ingredient. This ingredient is also called, among other names, Oxilofrine and p-hydroxyephedrine (hereinafter referred to as methylsynephrine).
 
Under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)], a dietary ingredient is a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Methylsynephrine is not a vitamin, a mineral, an herb or other botanical, or an amino acid. In addition, according to our research, methylsynephrine is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Finally, methylsynephrine is not a concentrate, metabolite, constituent, extract, or combination of a vitamin; mineral; herb or other botanical; amino acid; or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Accordingly, methylsynephrine is not a dietary ingredient within the definition set forth in section 201(ff)(1) of the Act. Declaring methylsynephrine in your product labeling as a dietary ingredient causes your products marketed as dietary supplements to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular.
 
We request that you take prompt action to correct the violation cited above, as well as any other violations associated with your XXX product or other products marketed by your firm that list methylsynephrine as a dietary ingredient in the labeling. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
 
Failure to immediately cease distribution of your XXX product, and any other products you market that list methylsynephrine as a dietary ingredient in the labeling could result in enforcement action by FDA without further notice. Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334]. 
 
Additionally, methylsynephrine is not approved as a food additive or prior sanctioned for use in dietary supplements. Further, FDA’s review of this substance does not identify a basis to conclude that the substance is GRAS [Generally Recognised As Safe] for use in food. If you contend that this substance is GRAS for use in food, please provide your basis for concluding that methylsynephrine is GRAS for use in dietary supplements, including supporting data or other documentation.”
Read more here.

Frutarom Launches New Phytopharmaceutical Ingredients Line

Frutarom Health BU, Switzerland, announces the launch of EFLA®pharm, a flagship proprietary product line comprised of both phytopharmaceutical ingredients and pharma flavors. The new product line for the pharmaceutical industry expands the established EFLA® brand, offering increased value to the pharmaceutical industry plus expertise in building a supply chain for sustainable, natural Active Pharmaceutical Ingredients that meet pharmaceutical manufacturers‘ needs. The EFLApharm family of products are scientifically supported, natural, pharmaceutical-grade herbal extracts. All are produced according to strict GMP guidelines.

Examples of herbals used in traditional medicine products under the EFLApharm brand include: Echinacea purpurea L.(purple coneflower), Hedera helix L. (common ivy), and Thymus vulgaris L. (thyme), all of which are key ingredients in the growing field of cough and cold therapeutics.

With the tremendous expansion in the use of traditional medicine worldwide, safety and efficacy — as well as quality control—of herbal medicines and traditional procedure-based therapies are major concerns for health authorities and the public.

Regulatory authorities protect public health while securing free movement of herbal medicinal products within a community, thus the process for licensing and information on herbal substances is being increasingly harmonized. EFLApharm products fall into the Traditional Herbal Medicinal Products (THMP) regulatory framework, and are suitable for global, pharmaceutical-quality submission, including the Drug Master File.

“Quality continues to be a major theme across the nutritional and pharmaceutical ingredients marketplace,” says Hadar Sutovsky, Global Manager of the Pharma & OTC segment at the Frutarom Health Business Unit. “Companies throughout the supply chain are taking a closer look at the quality of their ingredients and trying to determine better ways to deliver finished products of the highest quality. With EFLApharm, we can simplify access to the market for pharmaceutical companies striving to launch safe and effective herbal medicines.”

Active pharmaceutical ingredients sometimes taste bitter and/or irritate the mouth and throat, and thus are unpleasant not only to children but also to many adults. Flavorants are commonly used in pharmaceutical oral solutions and oral suspensions to mask bitterness and make the formulation more palatable. EFLApharm products offer GMP-quality fruitflavors with long-lasting taste profiles and masking properties. The ingredients are perfectly suited for oral care products, nutritional supplements, cough syrups and other pharmaceutical dosage forms.