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.

Food recalls in EU is back – Week 7/2016

Dear readers, the weekly articles about EU food recalls is back with a slightly modified format, to be even more immediate. January was an hectic period and I had big changes in my firm: that will lead to better organisation and an enhanced capacity to answer regulatory services requests, but it took me energy and time.

Soon you will have more information via the blog.

This week on EU RASFF (Rapid Alert System for food and feed) we can find the following relevant notifications:

1. Alerts followed by a recall from consumers:

  • Migration of melamine (3.1 mg/l) from melamine bowl from China, via Spain and via Italy, following an official control on the market. Notified by France, distributed also to Belgium, Luxembourg, Serbia and Slovenia.

2. Information for attention/for follow up followed by a recall from consumers:

None.

3. Alerts followed by a withdrawal from the market:

  • Listeria monocytogenes (210 CFU/g) in frozen olive focaccia brie oregano from Portugal, following company’s own check. Notified by France, distributed also to United Kingdom;
  • Metal particles (< 1 cm) in canned tortellini from Austria, following a consumer complaint. Notified by Austria, distributed also to Germany.

4. Seizures:

None.

5. Border rejections:

Country of notification Countries Concerned Subject Action taken
Denmark Denmark, Turkey (O) aflatoxins (B1 = 100; Tot. = 160 µg/kg – ppb) in hazelnuts from Turkey placed under customs seals
Germany Germany, Turkey (O) aflatoxins (B1 = 13.49 µg/kg – ppb) in roasted hazelnuts from Turkey re-dispatch
United Kingdom Brazil (O), United Kingdom aflatoxins (B1 = 13.9; Tot. = 15.7 µg/kg – ppb) in shelled groundnuts from Brazil use for other purpose than food/feed
Italy Italy, Turkey (O) aflatoxins (B1 = 15.3; Tot. = 16 µg/kg – ppb) in sweet apricot kernels from Turkey informing recipients
Slovenia Commission Services, Hungary, India (O), Slovenia, United States aflatoxins (B1 = 29.5; Tot. = 32.5 µg/kg – ppb) in nutmeg in shell from India, via the United States
Bulgaria Bulgaria, United States (O) aflatoxins (B1 = 3.3 µg/kg – ppb) in groundnuts from the United States placed under customs seals
France France, Turkey (O) aflatoxins (B1 = 3.3; Tot. = 24.1 µg/kg – ppb) in whole organic hazelnut kernels from Turkey return to consignor
Italy Egypt (O), Italy, San Marino (D) aflatoxins (B1 = 38.1; Tot. = 41.3 µg/kg – ppb) in peanuts in shell from Egypt placed under customs seals
Italy Egypt (O), Italy aflatoxins (B1 = 75.9; Tot. = 116.1 µg/kg – ppb) in peanuts in shell from Egypt placed under customs seals
Italy Azerbaijan (O), Italy aflatoxins (B1 = 9.5; Tot. = 10.2 µg/kg – ppb) in hazelnut kernels from Azerbaijan re-dispatch
Malta China (O), Malta aflatoxins (B1 = 9.8; Tot. = 12.0 / B1 = 4.5; Tot. = 5.6 µg/kg – ppb) in blanched peanuts from China placed under customs seals
Italy Italy, Turkey (O) aflatoxins (Tot. = 32.5 µg/kg – ppb) in shelled hazelnuts from Turkey official detention
Portugal Iran (O), Portugal, Turkey fenpropathrin (0.14 mg/kg – ppm) and ethion (0.024 mg/kg – ppm) and unauthorised substance propargite (0.030 mg/kg – ppm) in raisins from Iran, via Turkey re-dispatch
Italy Italy, Tunisia (O) hepatitis A virus (presence) in chilled clams (Ruditapes decussatus) from Tunisia destruction
Italy Italy, Tunisia (O) hepatitis A virus (presence) in chilled clams (Ruditapes decussatus) from Tunisia destruction
Italy Italy, Tunisia (O) hepatitis A virus in grooved carpet shells (Ruditapes decussatus) from Tunisia destruction
Italy Commission Services, Italy, Thailand (O) mercury (0.12 mg/kg – ppm) in canned cat food from Thailand import not authorised
Netherlands Brazil (O), Netherlands poor temperature control (-14 <–>-6 °C) of frozen salted skinless half chicken breasts from Brazil import not authorised
Italy Italy, Turkey (O) prochloraz (1.5 mg/kg – ppm) in pomegranates from Turkey
United Kingdom India (O), United Kingdom Salmonella (in 1 out of 5 samples /25g) in betel leaves from India import not authorised
Cyprus Cyprus, Ukraine (O) Salmonella (presence /25g) and Salmonella Senftenberg (presence /25g) in rapeseed meal from Ukraine official detention
United Kingdom India (O), United Kingdom Salmonella (presence /25g) in betel leaves from India import not authorised
Germany Germany, Thailand (O) Salmonella (present /25g) in frozen salted chicken breasts from Thailand re-dispatch
Slovenia India (O), Slovenia Salmonella Isangi (in 2 out of 5 samples /25g) in hulled sesame seeds from India placed under customs seals
France Brazil (O), France, Netherlands shigatoxin-producing Escherichia coli (stx1+, stx2- /25g) in chilled boneless beef meat (Bos taurus) from Brazil destruction
Bulgaria Bulgaria, China (O) spoilage of peanuts in shell from China infested with moulds re-dispatch
Spain Spain, Turkey (O) too high content of sulphite (2314-3399 mg/kg – ppm) in dried apricots from Turkey re-dispatch
Czech Republic Czech Republic, Vietnam (O) unauthorised substances carbendazim (0.25 mg/kg – ppm), hexaconazole (0.058 mg/kg – ppm), diafenthiuron (0.18 mg/kg – ppm) and chlorfenapyr (0.079 mg/kg – ppm) in fresh chilli peppers from Vietnam official detention

(Source: RASFF Portal)