Nutraceutical Provides Response to California AG Litigation

Park City, Utah, June 7 2018/PRNewswire/ — Nutraceutical Corporation today announced the following response to a press release issued earlier today by the California Attorney General’s office (the “California AG”) and several California counties regarding a lawsuit filed against Nutraceutical relating to the Peaceful Planet Plant Proteins Toddler Supreme protein supplement.

The California AG first contacted Nutraceutical on Friday, June 1st and Nutraceutical promptly informed the California AG the last sales of this product into California were made in February 2018 and that it voluntarily suspended any further sales pending completion of its own investigation. Nutraceutical informed the California AG that it has an opinion from a respected former FDA toxicologist that the Toddler Supreme protein supplement in fact contains ingredient levels that comply with applicable laws and regulation and does not pose any safety risk to Nutraceutical’s customers. Nutraceutical offered to supply the California AG with a formal written opinion from the former FDA toxicologist confirming that the Toddler Supreme protein supplement is safe, does not pose safety risks to Nutraceutical customers, and correcting the numerous factual errors in the California AG’s analysis of the product, but the California AG declined to wait to receive the information before moving forward with its lawsuit. Nutraceutical remains fully committed to the safety of its customers and their children, and intends to vigorously contest the lawsuit as it is believed to be without merit.

Additional Information about Prop 65

Proposition 65

Many California residents are familiar with a law known as Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986 or Prop 65. This law mandates that warnings be given to consumers in various circumstances. California residents see these warnings nearly everywhere — at gas stations, in parking garages, in hotel lobbies and on various consumer products.

The original concept of Prop 65 was to keep chemicals out of drinking water and to warn consumers before they are exposed to chemicals that may cause cancer, birth defects, or other reproductive harm. The California Office of Environmental Health Hazard Assessment (OEHHA) is responsible for publishing this list of chemicals and establishing the exposure levels that require warning statements. There are over 800 chemicals on the Prop 65 list. For example, under Prop 65 an exposure to an amount of lead over 15 micrograms per day requires a cancer warning, while an exposure to an amount of lead over 0.5 micrograms per day would require a reproductive toxicity warning. The level requiring a reproductive toxicity warning is set at a level 1000 times less than the level of exposure where there is no observable effect of harm, a level which is far lower than that set by the EPA or any federal agency. The vast majority of Prop 65 cases involving dietary supplements concern allegations of lead exposure.


When a warning statement is required on a consumer product, including a dietary supplement, it usually reads as follows:

For a carcinogen: ⚠ WARNING: Cancer —

For a reproductive toxin: ⚠ WARNING: Reproductive Harm —


Violations of Prop 65 are enforced by the California Attorney General, District Attorneys or by private party “bounty hunters” who are authorized to recover and keep part of the civil penalties recovered through a trial or settlement. As a result of the financial incentive offered to private parties to pursue these cases, lawyers and law firms have become “bounty hunters” and devoted their practices to pursuing settlements and recoveries. In a Prop 65 case, the only allegation is that the company failed to provide a warning – there is no claim that anyone has been harmed by the product at issue. There have been numerous Prop 65 cases and settlements involving dietary supplements.

Most Prop 65 cases settle prior to trial because the company bears the burden of proof to establish that a warning is not required on its products. In 2011, settlements with private party “bounty hunters” totaled over $15 million dollars – of which over $11 million was paid to the lawyers for the “bounty hunters.”


There have been several critiques leveled against Prop 65. Here are a few:

  • Prop 65 Unfairly Impacts Natural Products: Products with synthetic ingredients or which are heavily processed can more easily avoid introducing or remove natural contaminants. This unfairly impacts natural products. According to the Alliance for Natural Health, a grass-roots consumer group that seeks to promote health freedom in the United States,


“Some Prop 65 Chemicals are prevalent in the natural environment, and they unavoidably end up in supplements that contain natural ingredients. While there are certain allowable “safe harbor” levels for Prop 65 chemicals in a product, these levels are often either extremely low or must be established through complicated and expensive lab testing at the expense of the supplement company. Prop 65 does provide an exemption for “naturally occurring” chemicals – but it is up to the supplement company to prove that this is the case, which is both very difficult and expensive. In the end, supplement companies have the unfortunate choice of providing a prominent warning on what might in actuality be a very safe supplement, or not provide warning at all and risk noncompliance with Prop 65.” (A Guide to California’s Proposition 65, 2012).

  • The Prop 65 Bounty Hunter System is Broken: An article by Jim Conran, former director of the California Department of Consumer Affairs, claims that It’s Time to Tame Prop 65 Bounty Hunters, pointing out that what started out as an environmental protection law has turned into a system that mainly seems to enrich private lawyers. A March 2012 law journal article entitled Bounty Hunters and the Public Interest – A Study of Proposition 65 reviews Prop 65 actions and settlements and argues that the law has been abused by private bounty hunters and the California Attorney General should more actively oversee enforcement of the law.
  • Prop 65 Hurts Small Businesses: The group Citizens Against Lawsuit Abuse believes prop 65 enforcement actions are an abusive practice hurting small businesses.


Nutraceutical has an active Prop 65 compliance program, which includes the following elements:

Brochures: Nutraceutical has distributed to its California retailers brochures that include information about Prop 65 for consumers, including a warning. The latest version of that brochure is available at

Posters: Nutraceutical has distributed posters to all its retail consumers in California. Like the brochures, these posters provide a clear and reasonable Prop 65 warning to California consumers. Nutraceutical has asked that its retailers place these posters in their store(s) at prominent locations so that consumers can see them.

Warning Labels: Nutraceutical has applied Prop 65 warning labels to various products on the labels.


For more information on Prop 65, please see the following links: – The California Office of Environmental Health Hazard Assessment publishes an overview of Prop 65 on the website. OEHHA also is responsible for publishing the list of Prop 65 chemicals. These lists are available at the foregoing link.

Office of the Attorney General – The Attorney General’s website contains a database of Prop 65 notices of violation and settlements at


*The views stated in the articles are not necessarily the views of Nutraceutical, its directors, officers or employees.

California Prop 65 Warning

For cancer and reproductive toxicity endpoints: ⚠ WARNING: Cancer and Reproductive Harm —


Click here to return to the Notices page.


There has been a significant amount of media attention paid recently to Bovine Spongiform Encephalopathy (BSE) or “mad cow disease.” Concerns have been raised about various food products in the marketplace, including dietary supplements, and their potential connection to a variant of Creutzfeldt-Jakob Disease (vCJD) that appears to be caused by BSE.

No one knows for sure how BSE first emerged, but it does appear that certain 20th century farming practices have helped to spread it. News reports indicate that the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) are attempting to keep BSE out of the United States, even though there is currently no reliable test to detect BSE in a live animal. To date, we are aware of only one reported case of BSE in the United States. Various experts have expressed their view that the United States has enough safeguards in place to prevent a widespread outbreak.

As a leading manufacturer of dietary supplements, Nutraceutical Corporation (Nutraceutical) endeavors to assure that ingredients used in its products are of the highest quality and are carefully selected. As part of this commitment, Nutraceutical has instituted measures to ensure that it purchases bovine material only from suppliers that provide written certifications of their procedures regarding BSE. While the specific procedures vary by ingredient and supplier, examples of some of the procedures that have been instituted by such suppliers include:

  • Where possible, limiting the purchase of bovine material from countries where BSE has either not been detected or where enforcement and surveillance programs are well developed and enforced;
  • Process and control systems in sourcing and packaging;
  • Compliance with government surveillance programs; and
  • Compliance with other applicable regulations and guidelines, including those of the FDA, the European Commission and other governing bodies.

We believe that one of the most important steps that can be taken is for the FDA, the USDA, and other U.S. government agencies to commit the funds to research BSE and develop the testing methodology to allow all of us to ensure that the U.S. food supply remains BSE free. We urge our customers to write their congressmen to encourage the government to continue to give the highest priority to this matter.

The information contained in this statement is provided for educational purposes only and is current as of the date of publication. Although reasonable efforts have been made to provide accurate information, there is no guarantee that all of the information is accurate or current.

©2004 Nutraceutical Corporation. All rights reserved.

Answers to Questions About Kava Kava (Piper methesticum)

Historical Uses of Kava

Kava Kava – also known simply as kava – originated in the islands of the South Pacific, where it has been used for centuries as a ceremonial and communal drink. A member of the black pepper family, kava’s active properties appear to stem from the kavalactones found in its roots, which are dried and pounded into a powder and then mixed into a beverage. More recently, kava has become popular as a dietary supplement, either in capsule form (often using extracts from the roots) or as a beverage. Kava is best known for promoting relaxation.

Recent Government Actions

In recent months, there have been news reports regarding actions about kava by government agencies in various countries. Reports of liver-related risks associated with the use of kava have prompted regulatory agencies in countries including Germany, Switzerland, France, Canada and the United Kingdom to take actions ranging from warning consumers about the potential risks of kava to removing kava-containing products from the marketplace.

Germany has been at the forefront of these activities, and in early 2002 the German government announced a nearly complete ban on the sale of kava herbal medicines in Germany. Under the ruling, the sale of kava is only allowed in homeopathic products that contain minute amounts of kava. The chief herbal authority in Germany – the German Commission E – was apparently not consulted on the German government’s investigations. Recently, the German Commission E issued a press release indicating that it has reviewed available scientific data on the efficacy of kava and assessed the risk/benefit ratio and the therapeutic advantages, and determined that it continues to support kava’s availability as prescribed in medical product. The Commission also indicated it is of the opinion that there is no imminent danger which justified the German government’s action.

FDA Statements

In the United States, the FDA has issued a Consumer Advisory indicating that although liver damage appears to be rare, the FDA believes consumers should be informed of this potential risk.

The FDA has indicated that persons who have liver disease or liver problems, or persons who are taking drug products that can affect the liver, should consult a physician before using kava-containing supplements. The FDA has also stated that consumers who use a kava-containing dietary supplement and who experience signs of illness associated with liver disease should consult their physician. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Non-specfic symptoms of liver disease can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, and loss of appetite.

The FDA has indicated that it is continuing its investigation into the relationship, if any, between the use of kava-containing dietary supplements and liver injury. The agency’s investigation includes attempting to determine a biological explanation for the relationship and to identify the different sources of kava in the U.S. and Europe. The agency has indicated that it will alert consumers, and if warranted, take additional action as more information becomes available.

Industry Reaction in the U.S.

In the United States, there are two primary trade organizations involved with the manufacture and sale of herbal products: the Council for Responsible Nutrition (CRN) an the American Herbal Products Association (AHPA).  CRN is a science-based trade association for the dietary supplement industry that promotes responsible self-regulation, and AHPA is a trade association devoted to the U.S. herbal supplement industry.

In response to news reports about kava, both CRN and AHPA investigated the situation and developed cautionary statements for kava-containing dietary supplements. The CRN-sanctioned cautionary statement reads as follows:

Caution: The US FDA advises that a potential risk of rare, but severe liver injury may be associated with kava-containing dietary supplements. Ask a health care professional before use if you have or have had liver problems, frequently use alcoholic beverages, or are taking any medication. Stop use and see a doctor if you develop symptoms that may signal liver problems, including jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other nonspecific symptoms can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, and loss of appetite. Not for use by persons under 18 years of age, or by pregnant or breastfeeding women. Not for use with alcoholic beverages. Excessive use, or use with products that cause drowsiness, may impair your ability to operate a vehicle or heavy equipment.

CRN provided this statement to the FDA, an on July 22, 2002, the FDA sent a letter to CRN indicating that it believes that CRN’s caution statement regarding kava-containing dietary supplements is useful in providing information to consumers about liver injury and can assist consumers in making decisions and choices about dietary supplements.

Nutraceutical Products

Nutraceutical Corporation is a manufacturer of a variety of nutritional supplements, including products that contain kava. Nutraceutical cooperated with CRN and AHPA in developing new caution statements and has adopted the CRN statement.

Nutraceutical Corporation is committed to providing consumers with dietary supplement and natural food products that are of the highest quality and use carefully selected ingredients. Nutraceutical markets its products under various brand names, including Solaray®, KAL®, NaturalMax®, VegLife® and others. If you have any questions or concerns pertaining to kava-containing dietary supplements, please visit our website at Additional information may be found at or

The information contained in this statement is provided for educational purpose and is current as of the date of publication. Although reasonable efforts have been made to provide accurate information, there is no guarantee that all of the information is accurate or current.

©2002 Nutraceutical Corporation. All rights reserved.

Update on and Notice Regarding California Transparency in Supply Chains Act of 2010

On January 1, 2012, the California Transparency in Supply Chains Act of 2010 (SB 657) (“Act”) went into effect in the State of California. The Act is an attempt to seek the elimination of slavery and human trafficking from product supply chains and requires that companies disclose their efforts to ensure that their supply chains are free from slavery and human trafficking. Nutraceutical opposes slavery and human trafficking in any form and urges governments and government agencies around the world to take measures to eradicate these activities by outlawing and prosecuting violators. We are committed to supporting these efforts as a small cap company in the United States if there are viable steps we can take. We describe our current practices below.

Overview of Natural Ingredient Sourcing

Nutraceutical currently sells over 7,000 SKUs of products which incorporate over 2,000 raw materials, with their ultimate sources likely including regions in virtually every country in the world. Many of these ingredients are planted and harvested using traditional techniques developed over centuries if not millennia, while others are harvested using modern techniques. The suppliers can range from large businesses to small, family-owned farms, co-ops and harvesting operations, where products are sometimes wild-crafted (i.e., harvested from the wild). In some traditional family operations, family members of all ages may participate together and support each other and in fact enjoy working together, just as many farming operations in the United States have done since the founding of this country. Since growing conditions can change from year to year and season to season, buyers who work for Nutraceutical and for the natural product suppliers we purchase from must source these materials from a wide variety of vendors, which can change from year to year or even season to season. All of these factors create a particularly challenging situation for any company of our size to make a meaningful contribution in this area.

Supply Chain Standards

Nutraceutical expects its suppliers to ensure that quality and safety standards are maintained throughout our supply chain by well-treated, fairly compensated workers in accordance with all applicable laws. Our current efforts include the following:

  • Standards: Our contracts with our suppliers requires that they commit to us that they ensure that their activities and the activities of their suppliers comply with all applicable laws and regulations related to slavery and human trafficking as well as our Code of Ethics.
  • Verification and Audits: On those occasions when our purchasing team members have the opportunity to visit suppliers, they are asked to take the opportunity to inspect storage, production and/or harvesting facilities and operations and ask appropriate questions. We do not normally engage third parties to do this.
  • Certification: Our purchase terms contain a clause under which our direct suppliers certify to us that they comply with laws regarding slavery and human trafficking in the country or countries in which they do business.
  • Internal Accountability: If we were to determine that an employee or contractor has violated a law regarding slavery and human trafficking, this would constitute grounds for termination of the employment or supply relationship.
  • Training: Our purchasing personnel have been instructed to review these statements and our contracting terms and comply with them. Our Vice President over purchasing is responsible to ensure that existing employees and new hires are trained on these issues.

Update on “Dietary Supplement Safety Act of 2010” and Other Attacks on DSHEA

In 2010, Senator John McCain (R-AZ) and Senator Byron Dorgan (D-ND) proposed The Dietary Supplement Safety Act of 2010 (DSSA). As written, it would have had the effect of gutting key protections currently provided by the Dietary Supplement Health and Education Act (DSHEA). It would have also restored virtually unlimited control to the FDA to decide what supplements you can take and at what levels – within this agency are many individuals who have long tried to shut down the natural health industry. DSSA denies individuals the freedom to protect their own health. We were opposed to its passage.

After Washington D.C. was flooded with hundreds of thousands of phone calls and emails from concerned citizens, and after a phone call and public letter from Senator Hatch, Senator McCain withdrew his sponsorship for this bill. However, we should all remain vigilant to avoid any further erosion of the protections provided by DSHEA, no matter who is sponsoring the proposal and no matter what bill it is hidden in.

Here is some background:

  • DSHEA – this law has provided the framework for regulation of dietary supplements by FDA since 1994. It treats supplements as foods and gives FDA authority to remove unsafe or adulterated products from the market. It was the result of a massive grassroots effort to protect supplements from a history of overly aggressive regulation from FDA. See the positive commentsPresident Clinton made about it when he signed DSHEA into law. See an overview of the history of DSHEA from a former General Counsel of FDA, who reveals that FDA purposefully delayed its enforcement for over 10 years!


  • DSSA will Overturn DSHEA the passage of DSSA would effectively eliminate the supplement protections contained in DSHEA. It not only eliminates these protections, but actually grants the FDA unprecedented and arbitrary authority over what products you can take. View the article on The Alliance For Natural Health website or the article on the Natural Products Association website to see a discussion of this issue. The likely result of its passage? A consolidation of the supplement industry into a few big companies selling many fewer supplements and ingredients at much lower doses. And far fewer new products.


  • DSSA is an Effort to Divert Attention – DSSA appears to originate at least in part from major league sports teams who are trying to divert attention from illegal steroid use and their own failure to enforce anti-doping rules. One of the primary driving forces appears to be the US Anti-Doping Agency (USADA), which is funded by major league sports teams including baseball, football and others. Baseball commissioner Bud Selig has urged the adoption of DSSA. In his comments announcing the bill, Senator McCain cited six NFL players recently suspended for testing positive for banned substances who were allegedly exposed to these substances through “dietary supplements.” These parties are all missing the point: they should be focused on bringing an end to the underground and illegal conspiracy of suppliers, trainers and athletes who work together to find new ways of hiding and taking steroids and other performance enhancing drugs, which they might occasionally disguise as supplements. All of this has nothing to do with the traditional dietary supplement industry. These performance enhancing products and activities are or should be illegal and should be shut down by FDA. Unfortunately, FDA has a well-known history of failing to take illegal products off the market (see the Natural Products Insider article).


  • DSSA Doesn’t Solve Any Problems – DSSA is unnecessary and harmful. The FDA already has complete authority to remove illegal steroids from the market and to regulate dietary supplements. DSSA won’t stop irresponsible companies or criminals from breaking the law and will only hurt responsible companies. Athletes who want to take illegal products will still be able to find them. Criminals who want to supply these athletes will still find ways to do it. DSSA is not the solution to the problems faced by major league sports. The solution to that problem involves a major shift in sports culture and practices, which cannot be resolved by a bill that punishes vitamin manufacturers! Sports leagues are pushing a proposal that unfairly punishes everyone instead of simply cleaning up their own house.


  • Who Else is Opposed? The Natural Products Association and the Alliance for Natural Health have spoken out against this proposal (see below). We should all be vigilant to make sure someone doesn’t attempt to come up with a compromise bill. Senator McCain’s proposal and any compromise should be resisted at all costs.


  • Resources and Links — Consumers, retailers, natural care practitioners and others who are interested in opposing this proposal may wish to visit the following resources and links:Alliance for Natural Health (

Update on Red Yeast Rice Products

Some customers have contacted us regarding negative publicity about red yeast rice products marketed under our Solaray®, Natural Balance® and VegLife® brands. This publicity originated with a ConsumerLab review.

We want to reassure you that our manufacturing and testing processes are designed to ensure that our products meet applicable safety standards in the United States. We believe that our products are safe when used as directed. The ConsumerLab review should not be construed as evidence that our products are unsafe.


We sell traditional red yeast rice which is produced from the natural fermentation of the yeast, Monascus purpureus, on rice. Red yeast rice traditionally contains trace amounts of lovastatin – however, due to the regulatory status of red yeast rice, we focus our efforts on sourcing red yeast rice that has been manufactured according to traditional methods, which is the only kind of red yeast rice that meets FDA’s regulatory requirements. Traditional red yeast rice has been consumed for centuries.

We think it is important to note that FDA has historically pursued regulatory action against manufacturers and products that have moderate to high levels of lovastatin or make claims about the presence of lovastatin on their labels. See for example these warning letters:

Consumers should be cautious about purchasing products that are manufactured using techniques that increase or concentrate the amount of lovastatin above what is found in traditional red yeast rice. Some manufacturers may even be adding lovastatin. In either case, FDA would take the position that such products should not be sold or purchased as they violate the law in numerous respects, including lack of assurance of safety.


The ConsumerLab review contains some errors. One of the primary errors is its failure to note that among health food store brands tested by ConsumerLab, only Solaray®, Natural Balance® and VegLife® products contained levels of lovastatin within the range that FDA considers naturally occurring and safe. In fact, the ConsumerLab review suggests that consumers may wish to consider purchasing products with moderate to high levels of lovastatin – the very products that could be and have been subject to regulatory action and that FDA considers to be unacceptable and unsafe for dietary supplements.

We have made some suggestions to ConsumerLab regarding its approach to creating and publishing standards and some improvements to its business model. Here is a copy of our letter to them.


We screen our red yeast rice using UPLC-MS (ultra performance liquid chromatography-mass spectrophotometer detection). Current detection capabilities are down to 1 ppm.


ConsumerLab acknowledged in its review that there is no scientific basis to determine whether or not the levels of citrinin that ConsumerLab claimed to have found in our products and other products has any adverse health effects. We have consulted an independent toxicologist who has confirmed to us that the levels referenced in the ConsumerLab report do not raise a safety issue. Nevertheless, in order to continue to assure the highest level of quality for our products, we have expanded our screening program tests for citrinin in all red yeast rice raw material down to 1 ppm.


Nutraceutical has built its reputation as a superior quality supplement manufacturer by providing ingredients with guaranteed purity and potency. We are noted for having among the most stringent testing and quality control standards in the industry and are audited by an external auditor. Routine tests are performed for aluminum, lead and other heavy metals, more than 500 pesticides, herbicides and fungicides, microbial contaminants such as E. coli and salmonella, disintegration time and, of course, potency.

You can be confident that Nutraceutical products meet their stated label claims by being manufactured under strict quality control procedures, by being thoroughly screened for suspected contaminants and by using high quality ingredients.

FDA Re-evaluates Health Claims

On December 21, 2007, FDA announced that it intended to re-evaluate certain previously approved health claims and qualified health claims involving soy proteins, antioxidant vitamins and selenium. Read a copy of Nutraceutical’s submission to FDA.

The Ephedra Decision: The Real Story

On April 14th, 2005, a Federal District Court in Utah ruled against FDA’s ban on low-dose ephedra products. The plaintiffs were Nutraceutical Corporation and its subsidiary Solaray. We sued not just to protect our ephedra product, but to protect your access to other supplements. The FDA subsequently appealed the decision to the 10th Circuit Court of Appeals and on August 17th, 2006, the 10th Circuit Court of Appeals reversed and remanded. Nutraceutical subsequently petitioned for a rehearing but its petition was denied. Nutraceutical subsequently filed a petition for a writ of certiorari to the U.S. Supreme Court. On May 14, 2007, Nutraceutical’s petition was denied.

In the meantime, Nutraceutical filed a motion for summary judgment with the Federal District Court in Utah, and FDA responded with a cross-motion for summary judgment. On March 16th, 2007, the Federal District Court in Utah ruled in favor of FDA. However, in its decision, the District Court held that the risk-benefit test announced in FDA’s decision only applied to dietary supplements containing ephedrine alkaloids. Neither Nutraceutical nor FDA appealed this decision.

Industry-Related Codex Positions and Responses

See the Food and Drug Administration’s Responses to Questions about Codex and Dietary Supplements

See the Council for Responsible Nutrition’s Myths and Facts on Codex and WTO

See the National Nutritional Foods Association Position Paper as well as its Codex Alimentarius Resource Center.