Drug Enforcement Administration adds Code for Marihuana Extracts

The registration of marihuana extracts will take effect January 13, 2017 according to a notice filed by the DEA.  The notice defined marihuana extract as “containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.” 

Still being regarded as a Schedule 1 controlled substance, requiring an Administrative Controlled Substance Code number “7350”, will allow the DEA to tract the material and aid in compliance with international drug control treaties.

The Administrator, in accordance with the Regulatory Flexibility Act (RFA) has reviewed this rule and by approving it, certifies that it will not have significant economic impact on a substantial number of small entities/businesses.  The DEA already registers persons handling marihuana extracts but within another already established drug code 7360 and those persons who handle these marihuana extracts have already met DEA’s registration, security, and other statutory and regulatory requirements.  The only direct effect to registrants will to require the addition of the new drug code 7350 to their registration.

SENPA will continue to keep you updated on information that will affect your business.

​​Senators Blumenthal and Durbin Intend to Introduce

New Dietary Supplement Legislation in 2016

 Today SENPA learned U.S. Senators Richard Blumenthal (D-Conn.) and Dick Durbin (D-Ill.) have announced that they intend to introduce new legislation impacting the dietary supplement industry in 2016. This comes one day after the announcement that the Food and Drug Administration’s (FDA) Division of Dietary Supplements will be elevated to an Office. Both Senators believe that dietary supplements have outgrown the current legislative framework and therefore new comprehensive legislation is required for FDA's Office of Dietary Supplements to provide the necessary oversight. With details unclear at this point, SENPA will monitor legislative updates and keep a watchful eye how this will impact the industry, it is believed there will be increased transparency, more aggressive enforcement on those who neglect the law, and more regulatory burden on the industry at large.

​​The U.S. House of Representatives yesterday passed the highly debatable measure that blocks any mandatory labeling of foods made with genetically engineered crops, including pre-empting state laws that are set to take effect next year in Vermont.  Dubbed the Safe and Accurate Food Labeling Act by supporters, but the “Deny Americans the Right to Know” or DARK act, by opponents, the measure was approved 275 to 150 with 45 Democrats voting for the bill. 

Opponents of the Bill said they see it stalling in the Senate where a companion bill will be introduced, but supporters said they are finding growing support.

Southeast NPA will continue to monitor the progress on this highly debatable issue and keep you informed on any progress.

​​​Tell Congress to Vote No on S.A. 1463, 1560, 1561 & 1562 on National Defense Authorization Act (NDAA)

 As predicted longtime industry critics Senators Durbin (IL) and Blumenthal (CT) have once again started an attack against dietary supplements.  This year their initial attack comes in the form of four proposed amendments to NDAA which is the legislation which authorizes the budget authority for the Department of Defense (DoD) for the fiscal year 2016. These amendments all relate to dietary supplements in the military, more specifically “Monitoring of Adverse Event Data on Dietary Supplement Use by Members of the Armed Forces”, “Reporting of Dietary Supplement Use by Members of the Armed Forces” and finally the one with the potential to have the gravest impact on the industry “Limitation on Sale of Dietary Supplements in Commissary and Exchange Stores”.

While each of these four amendments raises many concerns, please find below the concern with each that we believe to have the most daunting impact:

  • Amendment 1560 is redundant in that FDA already has the authority to collect serious AERs for U.S. made supplements that are used in the U.S. including military installations. This information should go to the singular competent authority, in this case the FDA, in order to protect not only our military but also the entire U.S. population should there be any public health risk.
  • Amendment 1561 puts our soldiers’ privacy at risk as when disclosing any protected health information (PHI) the Military Health System (MHS) must make “reasonable efforts” to limit the use or disclosure to the “minimum necessary” to accomplish its intended purpose and any provisions covering such are absent in this amendment.
  • Amendments 1463 &1562 are burdensome because already have dietary supplement cGMPs (21 CFR Part 111) in place to ensure what is on the label is in fact in the product and failure to comply with these ensures real legal consequences. This provision would require a third party certification (not FDA) to those cGMPs which isn’t currently required by law. While a third party certification may have some utility for customer confidence, requiring them on military installations will only increase prices to soldiers while limiting access to products that are already compliant with federal laws for public health and safety.

 It is imperative that we band together to protect not only our industry but the brave men and women that fight for the United States of America. We need Congress to hear from as many of us as possible in opposition of these amendments so that they understand the impact this has on the industry that not only civilians but also our esteemed military personnel use day in and day out as a part of their preventive healthcare regime.   These amendments would impose redundant, burdensome and expensive regulations that would impede our soldiers’ access to the dietary supplements which they rely on to stay in fighting shape.

Please take a minute to let your elected officials know that it is imperative that when these amendments are brought to the floor for a vote, Congress must say no! 

New York Attorney General and Natural Products Association Agree to Collaborate to Promote Product Safety, Authenticity, and Transparency

AG Schneiderman and leading dietary supplement trade association announce plans to work together to educate supplement industry, consumers 

New York State Attorney General Eric Schneiderman and Daniel Fabricant, Ph.D., CEO of The Natural Products Association today issued the following joint statement:

“We share a common objective of ensuring herbal products bought by consumers are authentic, pure, and sold in full compliance with consumer protection laws. Anyone who buys an herbal supplement should be able to do so with full knowledge of what is in the product and have complete confidence that every precaution was taken to ensure its authenticity and purity.  While no single test or technology alone can provide complete confidence to consumers, we support the application of DNA barcoding technology as part of a multi-faceted approach to assuring authenticity and identifying substitution. This includes testing herbal/botanical ingredients prior to extraction in circumstances where DNA Barcode is available for the relevant species. Together, we look forward to jointly working with major manufacturers and retailers of herbal supplements to promote a model for product safety, authenticity, and transparency in this industry. We view this dialogue as a positive step in resolving our differences and we are hopeful that we can work in collaboration to enhance confidence and safe access for consumers.”​​​


New York Attorney General and Herbal Supplements: What Consumers Need to Know

What is the situation involving the New York attorney general and herbal supplements?

  • In February, New York Attorney General Eric Schneiderman sent cease-and-desist letters to four major retailers requesting they remove herbal supplements from store shelves after DNA barcoding tests found products supposedly contained DNA that was either unrecognizable or from a plant other than what was claimed on the label.
  • However, the study methodology used by the attorney general is not fit-for-purpose in testing herbal supplements, and he has since allowed one of the retailers to return the exact same products to its shelves after reaching an agreement with the company regarding product testing.
  • But even this has not stopped the New York attorney general from moving forward with his investigation, including sending a letter to Congress requesting it devote time and taxpayer dollars to the matter, or releasing his study data, which would help better understand exactly what was studied and how.
  • The attorney general is denying consumers access to goods based on reasoning that would not hold up under public scrutiny. If this situation continues to go unchecked, the way in which you buy goods in this country could be significantly impacted. Do you want your choices as a consumer to be curtailed in this manner? If the answer is no, then you must take action now.

 Is there something wrong with herbal supplements based upon the NY AG’s findings?

  • No. The New York attorney general’s argument is based on flawed science and application of a method that is not fit-for-purpose. There’s no evidence to suggest that these products are harmful or non-compliant with federal laws.
  • All of the botanical dietary ingredients that are the subject of the New York attorney general’s investigation have a long history of use and a strong library of research data supporting their health benefits.
  • Dietary supplement regulations are also in place to ensure the products are manufactured to high quality regarding their composition, strength, identity and purity, and are free of contaminants.
  • Dietary supplements are the only commodity of foods that has a 100 percent mandatory requirement for reporting serious adverse event reports (AERs) to the U.S. Food and Drug Administration (FDA). The agency monitors every single AER for safety issues, and uses the reports to remove supplements found to be unsafe from store shelves, request a voluntary recall, force a mandatory recall, or seize products found to be non-compliant with federal laws.

 Are dietary supplements regulated and who regulates them?

  • For more than 20 years, the FDA has had full regulatory authority and oversight of dietary supplement quality, safety, and labeling. The Dietary Supplement Health and Education Act of 1994 authorized the FDA to issue regulations to cover all aspects of supplement manufacturing.
  • State attorneys general, on the other hand, do not have the authority to pull supplements from shelves, whereas the FDA is fully equipped to go after dietary supplement manufacturers who do not play by the rules. Since that is not the case here, the FDA has not pursued action against any of the manufacturers in question.

 How can this affect you and your dietary supplements?

  • The actions and misinformation started by the New York attorney general has already spread to other states, including the attorneys general in Indiana, Connecticut, the District of Columbia, Hawaii, Idaho, Iowa, Kentucky, Massachusetts, Mississippi, New Hampshire, Pennsylvania, Rhode Island and the Northern Mariana Islands. The attorneys general from these states recently sent a letter to Congress asking them to investigate the supplement industry and expand the FDA’s regulatory authority over supplements.
  • Allowing state attorneys general to pull products off shelves without proper regulatory authority sets a dangerous precedent, which is a threat across all industries and significantly impacts consumer choice.

 What can you do?

  • Consumers must become active in the Natural Products Association’s grassroots efforts and prevent officials from removing products, especially without sharing the scientific basis for those requests. We must work together – by emailing, calling and tweeting – to compel the New York attorney general to share his data, and encourage the other attorneys general to rethink their involvement in Attorney General Schneiderman’s actions.
  • To participate, visit www.npainfo.org/grassrootsaction

 Dietary supplements are a safe part of a balanced approach to a healthy lifestyle, including good diet and exercise. Always consult with your doctor or health care professional before making any changes to your health care regimen.

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