PMID- 33488809
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240330
IS  - 1831-4732 (Electronic)
IS  - 1831-4732 (Linking)
VI  - 19
IP  - 1
DP  - 2021 Jan
TI  - Safety of water extract of Cistanche tubulosa stems as a Novel food pursuant to 
      Regulation (EU) 2015/2283.
PG  - e06346
LID - 10.2903/j.efsa.2021.6346 [doi]
LID - e06346
AB  - Following a request from the European Commission, the EFSA Panel on Nutrition, 
      Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on water 
      extract of Cistanche tubulosa stems as a novel food (NF) for its use in food 
      supplements (FS) and foods for special medical purposes (FSMP). The target 
      population is the general adult population excluding pregnant and lactating 
      women. The applicant proposes a maximum daily intake of 2 g for FS and a maximum 
      use level of 10% in FSMP. The characteristic components of the extract are 
      phenylethanoid glycosides (at least 70% of the NF), in particular, echinacoside 
      (25-45% of the NF). The NF has been authorised as a prescription drug in China in 
      2005 for the treatment of vascular dementia. The Panel notes that an integrated 
      analysis of three studies covering 1,076 patients with vascular dementia treated 
      with the proposed NF at a daily dose of 1,800 mg, reported that 12 adverse events 
      (AEs) were classified to be 'definitely', 'probably' or 'possibly related' to the 
      exposure to the NF. Two of these AE were classified as severe (cerebral 
      haemorrhage and epilepsy). The Panel considers that the reported AEs raise safety 
      concerns. The Panel also notes the limitations of the provided toxicological 
      studies, in particular the non-compliance with the EFSA approach on the 
      genotoxicity testing strategy and the non-compliance with good laboratory 
      practice (GLP) and the respective OECD Guidance documents of the repeated dose 
      toxicity studies. In view of the AEs in the human studies, the Panel considers 
      that additional toxicological studies, following testing guidelines would not be 
      able to overcome the concerns raised from the human studies. The Panel concludes 
      that the safety of the NF has not been established.
CI  - (c) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and 
      Sons Ltd on behalf of European Food Safety Authority.
CN  - EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens)
FAU - Turck, Dominique
AU  - Turck D
FAU - Castenmiller, Jacqueline
AU  - Castenmiller J
FAU - De Henauw, Stefaan
AU  - De Henauw S
FAU - Hirsch-Ernst, Karen Ildico
AU  - Hirsch-Ernst KI
FAU - Kearney, John
AU  - Kearney J
FAU - Maciuk, Alexandre
AU  - Maciuk A
FAU - Mangelsdorf, Inge
AU  - Mangelsdorf I
FAU - McArdle, Harry J
AU  - McArdle HJ
FAU - Naska, Androniki
AU  - Naska A
FAU - Pelaez, Carmen
AU  - Pelaez C
FAU - Pentieva, Kristina
AU  - Pentieva K
FAU - Siani, Alfonso
AU  - Siani A
FAU - Thies, Frank
AU  - Thies F
FAU - Tsabouri, Sophia
AU  - Tsabouri S
FAU - Vinceti, Marco
AU  - Vinceti M
FAU - Cubadda, Francesco
AU  - Cubadda F
FAU - Frenzel, Thomas
AU  - Frenzel T
FAU - Heinonen, Marina
AU  - Heinonen M
FAU - Marchelli, Rosangela
AU  - Marchelli R
FAU - Neuhauser-Berthold, Monika
AU  - Neuhauser-Berthold M
FAU - Poulsen, Morten
AU  - Poulsen M
FAU - Maradona, Miguel Prieto
AU  - Maradona MP
FAU - Schlatter, Josef Rudolf
AU  - Schlatter JR
FAU - van Loveren, Henk
AU  - van Loveren H
FAU - Gelbmann, Wolfgang
AU  - Gelbmann W
FAU - Knutsen, Helle Katrine
AU  - Knutsen HK
LA  - eng
PT  - Journal Article
DEP - 20210115
PL  - United States
TA  - EFSA J
JT  - EFSA journal. European Food Safety Authority
JID - 101642076
PMC - PMC7810154
OTO - NOTNLM
OT  - Cistanche tubulosa
OT  - Novel Foods
OT  - echinacoside
OT  - food for special medical purposes
OT  - food supplement
OT  - phenylethanoid glycosides
EDAT- 2021/01/26 06:00
MHDA- 2021/01/26 06:01
PMCR- 2021/01/15
CRDT- 2021/01/25 05:40
PHST- 2021/01/25 05:40 [entrez]
PHST- 2021/01/26 06:00 [pubmed]
PHST- 2021/01/26 06:01 [medline]
PHST- 2021/01/15 00:00 [pmc-release]
AID - EFS26346 [pii]
AID - 10.2903/j.efsa.2021.6346 [doi]
PST - epublish
SO  - EFSA J. 2021 Jan 15;19(1):e06346. doi: 10.2903/j.efsa.2021.6346. eCollection 2021 
      Jan.