Regulatory Update From Nature’s Sunshine December 2014: This brief quarterly report by Nature’s Sunshine is designed to provide members with a snapshot of the key regulatory issues affecting our industry and, where applicable, the Company’s role in those issues. Each quarterly newsletter will focus on some of the major developments in our industry since the previous edition.
INTERNET CAN BE BOTH HELPFUL AND HARMFUL TO NON-COMPLIANT RETAILERS.
Recently, the Food and Drug Administration (FDA) sent warning letters to two online marketing companies
because of labeling errors and unauthorized disease claims set forth on each of the companies’ respective
- On October 17, 2014, the FDA issued a warning letter to Golden Pride Inc., for labeling errors and making
unauthorized disease claims, including of “reduc[ing] the risk of heart disease and lower[ing] cholesterol
levels,” and that the “[product] benefits include providing antibacterial, antiviral, and antifungal properties
while aiding in the prevention of heart disease.” The FDA stated that such unauthorized disease claims would
make the company’s products unapproved new drugs.
- On October 9, 2014, the FDA issued a warning letter to Health Research Laboratories, LLC, for making
unauthorized disease claims such as “combats certain degenerative diseases such as Parkinson’s,
Alzheimer’s, and Huntington’s,” “can give relief from pancreatic conditions such as diabetes and
hyperglycemia,” and “days free from the pain of rheumatism, osteoarthritis and general joint aches.” The
FDA also cited the company for posting a letter from a medical doctor on its website that the promoted the
company’s products for disease conditions.
These recent FDA warning letters are good reminders, that it is imperative to follow the Nature’s Sunshine Policies and Procedures, including not making disease claims, either verbal or written, whether in print or online format, related to Nature’s Sunshine’s products.
THE DIRECT SELLING ASSOCIATION (DSA) VOTER RESULTS OF THE NOVEMBER 2014 ELECTION.
All but two DSA-supported candidates were elected. With the Republican party now holding the majority of both houses of Congress, the dietary supplement industry are hoping to see some positive changes, however, the newcomers will still need to be educated. The dietary supplement and direct selling industry as a whole will need to stay involved. NSP will continue to meet with Politicians and educate them on our industry.
REPRESENTATIVES FRANK PALLONE JR., AND JASON CHAFFETZ TAKE POSITIONS ON KEY COMMITTEES: The nutritional supplement industry is happy to welcome in Representative Frank Pallone (D-NJ) as a replacement for Representative Henry Waxman (D-CA). Representative Waxman was an industry critic and was on the House Energy and Commerce Committee. Representative Pallone, friendly to the industry, will now be the ranking democrat on the House Energy and Commerce Committee. Michael McGuffin, President of American Herbal Product Association (AHPA) said, “As the popularity of herbal products continues to grow, it is critical that the industry is well represented on this influential committee. AHPA looks forward to working with Rep. Pallone and the rest of the committee to promote the responsible commerce of herbal products.” The nutritional supplement industry is also pleased with Representative Chaffetz (R-UT) winning the race to become chairman of the House Government Reform Committee. Patricia Knight and Peter Reinecke, Senior Political Advisors for the United Natural Products Alliance (UNPA), have stated “[w]hile the Government Reform Committee does not write legislation on supplement issues, it is a critical committee in that it has oversight authority over all federal agencies including FDA and FTC.” Representative Chaffetz has a strong interest in supplement issues, which could be very helpful to the industry. It is helpful to have political support in these critical committees in Congress.