Alfa Fem’Com

1.  Overview of the advantages of Alfa Fem’Comfort

• Alfa Fem’Comfort provides a fast effectiveness against the main symptom of menstrual discomfort: mood swings.
• Clinical studies performed with Persian saffron extracts have demonstrated a significant improvement of emotional balance after only one week of oral supplementation.
• Quality compliance – Alfa Fem’Comfort is 100% organic, vegan, GMO free, allergen free, BSE free, and nanoparticles free

2.  Synergistic Ingredients

• The ingredient: patent-pending hydro-alcoholic extract of stigmas from Persian saffron. Saffron (Crocus sativus L.) has been traditionally used for millennia by Asian and Persian medicines to relieve mood swings associated with menstrual disorders. Obtained from the reddest part of saffron stigmas (Sargol quality), it provides the richest concentrations in safranal, crocin and safromotivines.
• Yarrow (Achillea millefolium L.): the European Medicines Agency (EMA) recognizes this plant as “a traditional herbal medicinal product for the symptomatic treatment of dysmenorrhea (abdominal cramps)”, observed in more than 50% of women during premenstrual periods.
• Feverfew (Tanacetum parthenium (L.) Sch. Bip.): traditionally used for 2000 years against menstrual pain, amenorrhea (absence of menstruation) and headaches.
• Hibiscus (Hibiscus sabdariffa L.): traditional plant used to soothe gastrointestinal spasms.

3.  Clinical evidence

• A proprietary consumers study* has confirmed the product benefits on mood: 3 out of 4 consumers are satisfied by its effectiveness and 2 out 3 consumers feel their emotional balance improved.
• Benefits on both emotional and physical symptoms involved in premenstrual discomfort have been demonstrated in 4 published clinical studies.
• Yarrow: A double-blind randomized clinical trial on yarrow shows that this plant is effective in minimizing the pain severity in primary dysmenorrhea.

Publications: BS-08-A3, BS-01-F4, BS-02-F4, BS-09-A3 (available on request) *Consumers study on 50 healthy volunteers supplemented with 30 mg/day of Safr’Inside™ for 15 days.

4.  Mechanism of Action

• Saffron acts as an efficient mood stabilizer, acting as a cortisol blocker and a selective serotonin reuptake inhibitor (SSRI): MOOD STABILIZER
• Yarrow provides anti-inflammatory and antispasmodic effects allowing relieving primary dysmenorrhea and increasing abdominal comfort: PREMENSTRUAL ABDOMINAL WELL-BEING

5.  Composition

• Feverfew aerial part powder* (Tanacetum parthenium (L.) Sch.Bip.); Hibiscus flower powder* (Hibiscus sabdariffa L.); Coating agent: HydroxyPropylMethylCellulose Safr’Inside™: Saffron stigma extract* (Crocus sativus L.); Yarrow aerial part extract* (Achillea millefolium L.). *Ingredients from Organic Farming

6.  Per soft gel:

• Organic Feverfew aerial part powder (Tanacetum parthenium (L) Schi.Bip.)150 mg
• Organic Hibiscus flower powder (Hibiscus sabdariffa L.) 150 mg
• Safr’Inside™: Organic Saffron stigma extract (Crocus sativus ) 35 mg, of which Safromotivines 4,2 mg
• Organic Yarrow aerial part extract (Achillea millefolium ) 35 mg

7.  Pantent:

• Tech’Care Extraction™ patent-pending (FR 1657297 – PCT/EP2017/069200): “Plant extract highly concentrated in safranal, process of obtaining and uses.”

8.  FAST EFFECTIVENESS: ONE WEEK

• Alfa Fem’Comfort provides a fast effectiveness against the main symptom of menstrual discomfort: mood swings.
• Clinical studies performed with Persian saffron extracts have demonstrated a significant improvement of emotional balance after only one week of oral supplementation.

Publications: BS-01-A3, BS-03-A3, BS-06-A3 (available on request)

9.  EFSA PENDING CLAIMS:

• Saffron helps to maintain good comfort before and during menstrual cycle. (Entry ID 2251)
• Yarrow soothes periodic abdominal cramps. (Entry ID 2760)

10.  AUTHORIZED LABELING:

• France: Premenstrual Comfort Organic has been registered with the French authorities (DGCCRF), guaranteeing its marketing authorization. Nevertheless, this registration doesn’t constitute a guarantee of conformity with current regulations. (see packaging in appendix)
• Belgium: According to Belgium authorities, the EFSA claim “Yarrow soothes periodic abdominal cramps”, is not authorized. But the wording “Yarrow contributes to abdominal comfort during the premenstrual period” has been accepted through the notification procedure, even though the assignment of a notification number shall not be considered as an endorsement of the claims used and / or the manner in which they are formulated. (see packaging in appendix)
  

11.  Technical Data

• Dosage form: HPMC (hydroxypropylmethylcellulose) capsule, size 0, transparent
• Primary packaging: White PET pillbox (100ml) of 30 capsules, with sealed tamper-proof cap PP label 130x57mm, quadricolor
• Secondary packaging: Box 50x50x90mm, 295g, quadricolor, acrylic varnish (See appendix) Package insert and selective UV varnish in option 
• Net weight:9 g – 465 mg/capsule
• Shelf life: 36 months after production date if stored in the original closed packaging and protected from light exposure in a clean, cool and dry place.