September 20, 2010
Natural is definitely the new black, as more consumers turn away from conventional over-the-counter (OTC) and pharmaceutical drugs. Synthetic side effects are often thought of as worse than the disease. Botanicals, with a definition of a medicinal preparation derived from a plant (according to Merriam-Webster), are just about as natural as consumers can get.
And it seems those consumers cant get enough products made from botanicals. From dietary supplements to cosmeceuticals, not to mention functional foods and beverages, botanical ingredients are found in a wide variety of products. They arent sitting on the shelves either. HerbalGram, published by the American Botanical Council (ABC), reported a 14-percent increase in sales of herbal and botanical products in 2010 compared to 2009 in mainstream U.S. food, drug and mass markets (not including Wal-Mart or Sams Club). The report, published in July 2010, also noted numerous market data companies have reported growth in herbal dietary supplements, multi-herb formulas, and functional and conventional foods.
With increasing sales, the market is rich with opportunities for growth. As the world of botanicals is largely untapped in the food and beverage industries, product manufacturers have a new wealth of options for ingredients to add to their products attributes, and those brands that move first will enjoy this advantage, said Angela Dorsey-Kockler, R.D., product manager, BI Nutraceuticals. There is a large consumer trend toward more natural ingredients, or reaping health benefits in natural ways. Botanicals, which include everything from leaves to roots to flowers to berries, offer an extremely natural twist to products.
Botanicals, with their myriad benefits, were just waiting for the rest of us catch on, according to Rudi E. Moerck, president and CEO, Valensa. Two decades ago, natural botanicals were already addressing some of the hottest trends of personal consumption that are just emerging now, including the natural and green movements, the issue of global sustainability, the vegetarian/vegan and organic movements, as well as increased awareness of side effects coming from the products of the pharmaceutical industry. Today, botanicals are moving beyond specialty health-food stores and into the mainstream as both nutritional supplements and nutrients in functional foods.
Because consumers are so keen on botanicals, product manufacturers have a strong interest in botanical ingredients, especially those that are new or have clinical evidence supporting their effectiveness, according to Christian Artaria, marketing director and head of functional food development, Indena. Interest from manufacturers relates to a leadership position they are seeking to occupy within a certain segment based on consumer demand for a particular ingredient or health position.
Luckily for manufacturers and consumers alike, the list of studies on botanical ingredients is long and established, and covers both new offerings and those that are more established in the market.
To name just a few, taiuiá or tayuya (Cayaponia tayuya, Cucurbitaceae) is a climbing, lignified plant with a large swollen root that has traditionally been used as an anti-inflammatory and anti-rheumatic agent in the folk medicine of Brazil, Peru and Colombia. An in vivo experiment on tayuya found 22.30 microg/mL of butanol extract of cayaponia inhibited inflammation markers; both iNOS and COX-2 expression decreased by 98 percent and 49 percent, respectively.1
Bilberry juice also reduced inflammation in a February 2010 study.2 Researchers at the University of Oslo, Norway, found a group drinking bilberry juice experienced significant decreases in plasma concentrations of C-reactive protein (CRP; which rises when there is inflammation), interleukin (IL)-6, IL-15 and monokine induced by INF-gamma compared to placebo. The authors wrote, These findings suggest supplementation with bilberry polyphenols may modulate the inflammation processes. Further testing of bilberry supplementation as a potential strategy in prevention and treatment of chronic inflammatory diseases is warranted.
Billberry, and other dark-colored berries, are high in anthocyanins, which may be behind those anti-inflammation properties; but, one study noted for sure these anthocyanins exhibit interesting antioxidant properties, and could represent a promising class of compounds useful in the treatment of pathologies where free-radical production plays a key role.3
A 2008 study found the antioxidant compounds of one botanical helped cancer treatments. The liver protection afforded by gomisin A, a lignan compound from Schisandra fructus, a fruit native to East Asia, is the result of the reduced oxidative stress and its anti-apoptotic activity.4
Additionally, long-term Schisandrin B (Sch B), a dibenzocyclooctadiene-derivative isolated from the fruit of Schisandra chinensis, treatment could enhance cerebral mitochondrial antioxidant status as well as improve mitochondrial structural integrity, thereby protecting against brain damage.5
Consumers looking for digestive health products can also turn to botanicals, such as pysllium, derived from the husks of the seeds of Plantago ovate, Dorsey-Kockler noted. While pysllium has been used for years as the ingredient in Metamucil, it is becoming popular as an ingredient for crackers, breads, smoothies and more because of its ability to increase fiber content, as well as viscosity of foods. As fiber is a hot buzzword now on food labels, and digestive health is a sought-after consumer benefit, psyllium is well positioned to help meet these trends. In fact, psyllium is one of the few ingredients that is qualified for a heart-health claim, according to FDA. She added other ancient grains such as quinoa and chia seeds are well positioned to meet a variety of health benefits and consumer needs, including gluten-free, vegetarian protein source, high fiber and high in antioxidants. In addition, chia seed delivers a high level of omega-3 fatty acids, which also supports heart health.
Moerck pointed out the plant-based omega-3 alpha-linolenic acid (ALA) aids the heart. Studies that have focused on the ratio of linoleic acid (LA) to ALA show clear evidence that the nations with high ratios have much greater incidence of mortality from cardiovascular disease (CVD). In the United States and Europe, where the LA/ALA ratio is 30:1, the CVD mortality is 45/1,000. In Inuit populations where LA/ALA is 1:1, that rate drops to 5/1,000. He added low levels of ALA supplementation have been reported to have profound effects both before and after myocardial infarction.
Chinese red yeast rice (Monascus purpureus) has also shown heart-health benefits with a significant reduction of serum total cholesterol levels, triglycerides levels and low-density lipoprotein ( LDL) cholesterol levels, and increase of high-density lipoprotein (HDL) cholesterol levels compared with placebo in a study from Norway.6 And, in an Annuals of Internal Medicine Summary for Patients, designed to help patients better understand the complicated and often mystifying language of modern medicine, authors noted a 24-week study of 62 patients with high cholesterol levels and a history of stopping statin therapy because of muscle pain found LDL cholesterol levels decreased more in patients receiving red yeast rice (average decrease, 35 mg/dL) than in patients receiving placebo (average decrease, 15 mg/dL).7
pTeroPure, a trans pterostilbene offered by pTeroPure Inc., is like resveratrol in that it is a natural stilbenoid found in small berries, such as blueberries and grapes, and offers heart-health benefits, according to Jeremy Bartos, Ph.D., ingredients product manager, pTeroPure. Among other things, there are published reports of the effectiveness of pterostilbene in lowering cholesterol, lowering blood pressure, lowering blood glucose levels, alleviating oxidative stress and acting as a powerful antioxidant. It also has anti-cancer properties, he said.
Andrographis panaiculata is a botanical native to India and Sri Lanka traditionally used to boost immune function. A Russian outpatient clinic backed that tradition with science when it conducted two randomized, parallel-group clinical studies with a standardized extract (SHA-10) of Andrographis panaiculata (N.), and found significant differences in the duration of sick leave and frequency of post-influenza complications compared to placebo.8 The researchers noted the phytopreparation not only contributed to quicker recovery, but also reduced the risk of post-influenza complications.
And, botanicals can help in the bedroom as well. Icariin, commonly known as Horny Goat Weed or Yin Yang Huo, is a compound derived from several species of plants in the Epimedium family. It has testosterone-mimetic properties with the therapeutic potential to manage hypoandrogenism, a deficiency of androgens in the body leading to a lack of virility and sexual potency.9
Indena markets a range of botanical ingredients for specific health conditions. Indena's best-selling offerings, according to Artaria, include bilberry for eye and cardiovascular health; grape seed for anti-aging, cardiovascular heath and joint health; green tea for energy, weight management and womens health; and olive pulp for healthy skin and lipid peroxidation.
Moerck added to the list: saw palmetto (saw palmetto extract oil is the only type of saw palmetto product that has been used in every successful clinical trial for mens urinary tract health to date); and spirulina.
Still, this is just a tiny fraction of all the beneficial botanicals and the health issues they address. To help manufacturers and consumers find more information on the herbs and botanical ingredients, ABC offers the Healthy Ingredients database of botanicals used for cosmetics, aromatherapy and dietary supplements. The database offers overviews that highlight historical and modern uses, research from human clinical trials, and a future outlook that addresses availability, market statistics and sustainability issues. ABC also offers HerbClip, summaries and critical reviews of seminal articles covering research, regulation, marketing and responsible use of medicinal plants; and the HerbalGram, a scientific quarterly journal on botanicals.
Botanicals can be delicate creatures, and need to be treated as such during formulation and processing to ensure finished products are efficacious.
Indena, for instance, developed its PHYTOSOME delivery system technology to help increase bioavailability. Many phytoconstituents like polyphenolics have good water solubility, but are, nevertheless, poorly absorbed because of their large size, incompatible with a process of passive diffusion and/or their poor miscibility with oils and other lipids, Artaria said. Phenolics show a high affinity for biological membranes, and, once complexed with phospholipids, are embedded into a lipid matrix that, while shielding them from hydrolytic degradation, can capitalize on the rapid exchange of phospholipids between biological membranes and the extracellular fluids, shuttling [botanicals] into biological membranes and increasing cellular captation. These PHYTOSOME combinations result in markedly enhanced bioavailability over their standard botanical forms.
Valensas main processing focuses are extraction, stability and shelf life, Moerck said. It employs DeepExtract ultrahigh pressure carbon dioxide extraction technology. It offers extremely high extraction efficienciesdelivering more of the higher molecular weight compounds that more closely track the natural source materials. Put another way, it delivers more of what nature offers. The process is flexible and allows for fractionation of the product and the delivery of very specific compounds out of the raw material. Additionally, DeepExtract offers gentle treatment of raw materials at low-temperature levels and creates ingredients for products that can be marketed as all-natural and organic.
Because botanical ingredients are subject to rapid oxidation and rancidification if left unprotected, Moreck said Valensa uses O2B Peroxidation Blocker system. O2B is an application-specific formulation that combines highly effective botanical ingredients to prevent destructive oxidative, photochemical and rancification reactions, he said. O2B is useful for protecting expensive and sensitive compounds, such as carotenoids and polyunsaturated fatty acids.
Draco uses a full-spectrum water extraction process for a carrier-free, solvent residue-free formulation. This allows for formulation into water-soluble personal care products for smooth, grease-free skin products, as well as easy dispersion into foods and beverages, said Brien Quirk, director of R&D, Draco Natural Products.
Steam sterilization allows BI Nutraceuticals to sterilize botanicals without significantly altering the nutritional or organoleptic properties of the material, Dorsey-Kockler noted. This is extremely important when the goal is to protect and maintain a specific level of bioactive compounds in the botanical.
Steam sterilization helps maintain bioavailability, but its main goal is to make sure the botanicals are sanitized and safe. All the new botanicals from all over the world and the innovative ways to process them are exciting indeed, but modern methods can pose new dangersand new health risks. The U.S. Pharmacopeial Convention (USP) hopes to help reduce the safety threats from all for supplements and their ingredients, including botanicals.
USP has been establishing botanical monographs for the U.S. market for 200 years. These monographs include the name of the ingredient or preparation; the definition; packaging, storage and labeling requirements; and the specification. The specification consists of a series of tests, procedures for the tests and acceptance criteria. If a finished good or an ingredient falls short of the list or requirements, it may be harmful to circulate to the public.
As a public health mission-orientated organization, we feel its important to get quality standards out in the public domain for products and ingredients that are in commerce, said Jim Griffiths, vice president of food, dietary supplement and excipient standards, USP. If the public is being exposed to these types of products, the public also deserves the best quality, and we can supply quality standards. In other words, we offer a yardstick against which the manufacturers can target their products and offer to the public the best ingredients possible.
USP offers a verification program to manufacturers whose product met or exceeded USPs standards. The USP Verified Mark ensures the public that a finished good: contains the ingredients listed on the product label, in the declared strengths and amounts; does not contain harmful levels of contaminants; will breakdown and release ingredients in the body within a specified amount of time; and has been made under good manufacturing practices (GMPs). After a dietary supplement has been verified, USP will periodically conduct random, off-the-shelf tests to ensure the product continues to meet USPs standards. USP also continues to conduct GMP-compliance audits of a manufacturing site on a three-year basis. To maintain the Verified Mark during the intervening years, manufacturers are required to conduct annual self-audits and report results to USP for review.
Beyond third-party tests, many manufacturers support studies and tests of their ingredients to ensure safety. The CO2 process used by Valensas DeepExtract offers virtual sterilization of the finished product and biomass without chemical residues, according to Moerck. DeepExtract products are devoid of impurities and residues that can resonate with the safety concerns of consumers.
And, Quirk noted Dracos primary concerns are proper testing and cleaning procedures to assure low-lead and heavy-metal levels. The company uses a closed system, water extraction and spray-drying process to sterilize and make sure bacterial count levels are low. This is all done without the need for irradiation so that food, beverage and cosmetic companies can safely use our ingredients with full confidence, he said. For our industry customers, scientific validation and quality control certifications are key for positive market reception.
Advanced processing techniques and safety strategies allow for diversified products, as well as effectiveness. Dorsey-Kockler added different types of mixtures are better for some applications. Granulated materials offer easy manufacture of dietary supplements; water-soluble extracts offer solubility of botanicals for beverage applications; and powder botanicals can be mixed in with other dry ingredients in snacks in a cost-effective manner.
Ten years ago, supplements were the most popular delivery form of botanicals, according to Artaria. Now, however, There has been significant innovation to broaden the applications so individuals can get a particular ingredient in a wide variety of forms that include supplements, beverages and foods. This innovation will continue to meet new consumer demands. Consider, he said, the growth of energy shots made with botanicals.
Supplements still reign supreme in the botanical delivery arena, according to Bartos. They are easy to make, easy to take, easy to formulate, and dont have the regulatory hoops that functional foods and beverages have. He did add cosmetics and other skin-care products are also gaining popularity as a vehicle for botanicals.
Quirk agreed the cosmeceutical botanical market is growing. The increasing desire of consumers to look good, coupled with an aging population and the growing availability of high-performance cosmetics, will drive this.
Diverse, efficacious, safe botanical ingredient and products will be the catalyst for growth in this market. Elan Sudberg, CEO at Alkemists Labs, said, The future for natural botanical ingredients as we see it is going to be largely dependent on improved regulations for acceptable testing measures that better ensure safety and quality. For example in the past 12 months, we have seen a jump in more FDA warning letters issued to companies that fail to meet identity testing requirements on their finished products, which is a great start. However, we think a larger success for this market will come as a result of suppliers better understanding their customers (i.e. manufacturers) needs and production issues relating to the raw materials they are selling, such as identity/screening, in-process testing, finished products analysis and even stability.
GRAS (generally recognized as safe) status, if it were approved for more botanical ingredients, may also help boost this market. It will be exciting to see a plethora of botanicals cross over from the traditional spot in the dietary supplement industry into the food and beverage sectors, Dorsey-Kockler said. As consumers continue to become more familiar with many of the botanicals that are positioned for specific health benefits, consumers will be more open to seeing those botanicals in their foods. Additionally, exciting potential comes from the continued progress of granting botanicals GRAS status by FDA. BI Nutraceuticals already offers more than 200 GRAS botanicals for use in foods and beverages, and we look forward to many more botanicals achieving GRAS status.
Manufacturers can spend hours daydreaming with predictions for which botanicals will be popular in the future. There are an unlimited number of potential botanicals that could enter the market, and I dont think anyone has a clue what the next acai might be and how much of the market share it will get, Griffiths said. The next hot botanical could be growing in your backyard right now. There is so much we dont know about the less-developed parts of the world where they have traditional botanicals they use for flavoring in cooking or use as part of their regimen. If they live longer with less cancer, everyone will want to track what they are doing. We are on a huge growth curve all around the world with this type of ingredient.
With so many botanicals blooming in the supplement, food, beverage and personal-care industries, its no wonder sales are increasing and researchers are logging lab time. Still, consumer interest can quickly be diminished if ingredients arent formulated with the utmost care thats required to make myriad, safe and beneficial products.
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References for Flower Power
1. Aquila S, et al. Anti-inflammatory activity of flavonoids from Cayaponia tayuya roots. J Ethnopharmacol. 2009 Jan 21;121(2):333-7.
2. Karlsen A, Paur I, Bohn SK, et al. Bilberry juice modulates plasma concentration of NF-kappaB related inflammatory markers in subjects at increased risk of CVD. Eur J Nutr. Sep2010;49(6):345-55.
3. Acquaviva R,et al. Cyanidin and cyanidin 3-O-beta-D -glucoside as DNA cleavage protectors and antioxidants. Cell Biol Toxicol. 2003 Aug;19(4):243-52.
4. Kim SH, et al. Anti-apoptotic and hepatoprotective effects of gomisin A on fulminant hepatic failure induced by D-galactosamine and lipopolysaccharide in mice. Pharmacol Sci. 2008 Feb;106(2):225-33.
5. Chen N, Chiu PY, Ko KM. Schisandrin B enhances cerebral mitochondrial antioxidant status and structural integrity, and protects against cerebral ischemia/reperfusion injury in rats. Biol Pharm Bull. 2008 Jul;31(7):1387-91.
6. Liu J, et al. Chinese red yeast rice (Monascus purpureus) for primary hyperlipidemia: a meta-analysis of randomized controlled trials. Chin Med. 2006 Nov 23;1:4.
7. Becker, D., et al. Summaries for patients. Red yeast rice to treat cholesterol problems in patients who cannot tolerate statin therapy because of muscle pain. Ann Intern Med. 2009 Jun 16;150(12):I28.
8. Kulichenko LL, et al. A randomized, controlled study of Kan Jang versus amantadine in the treatment of influenza in Volgograd. J Herb Pharmacother. 2003;3(1):77-93.
9. Zhang ZB, Yang QT. The testosterone mimetic properties of icariin. Asian J Androl. 2006 Sep;8(5):601-5.
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